October 2009 Vol 1, No 1 by Novellus Healthcare Communications, LLC

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Clinical News Adult Osteoporosis Linked to Low Birth Weight Results of a new study show that preterm babies with very low birth weight (VLBW) are at increased risk for osteoporosis or low bone mineral density (BMD) later in life. VLBW was defined as infants weighing <1500 g at birth. The study was based on data from

the Helsinki Study of Very Low Birth Weight Adults, a cohort study representative of the VLBW population around Helsinki between 1978 and 1985. This new study included 144 preterm-born VLBW young adults and 139 term-born controls, matched for sex, age, and birth hospital. BMD was assessed by measuring skeletal health.

Analysis showed that the pretermborn adults were twice as likely to have low BMD at the lumbar spine during early adulthood than the term-born controls, suggesting that a compromised BMD level at birth increases the risk of osteoporosis later in life. These findings have immediate implications for those dealing with

preterm babies or their parents. The researchers advise that these findings emphasize the need to promote adequate nutrition measures, with sufficient calcium and vitamin D, as well as weight-bearing exercise for those with VLBW. (Hovi P, et al. PLoS Med. 2009; 6:e1000135. Epub 2009 Aug 25.)

New Analysis Confirms Role of Antioxidants in Sperm DNA ®

CRINONE 4% CRINONE® 8% (progesterone gel) See package insert for full prescribing information. INDICATIONS AND USAGE Assisted Reproductive Technology Crinone 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency. Secondary Amenorrhea Crinone 4% is indicated for the treatment of secondary amenorrhea. Crinone 8% is indicated for use in women who have failed to respond to treatment with Crinone 4%. CONTRAINDICATIONS Crinone should not be used in individuals with any of the following conditions: known sensitivity to Crinone, progesterone or any of the other ingredients; undiagnosed vaginal bleeding; liver dysfunction or disease; known or suspected malignancy of the breast or genital organs; missed abortion; active thrombophlebitis or thromboembolic disorders; or a history of hormoneassociated thrombophlebitis or thromboembolic disorders. WARNINGS The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose. PRECAUTIONS General 1. The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear. 2. In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, nonfunctional causes should be considered. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken. 3. Because progestogens may cause some degree of fluid retention, conditions which might be influenced by this factor (e.g., epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. 4. The pathologist should be advised of progesterone therapy when relevant specimens are submitted. 5. Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. 6. A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progestin therapy. Information for Patients The product should not be used concurrently with other local intravaginal therapy. If other local intravaginal therapy is to be used concurrently, there should be at least a 6-hour period before or after Crinone administration. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage. Drug Interactions No drug interactions have been assessed with Crinone. Carcinogenesis, Mutagenesis, Impairment of Fertility Nonclinical toxicity studies to determine the potential of Crinone to cause carcinogenicity or mutagenicity have not been performed. The effect of Crinone on fertility has not been evaluated in animals. Pregnancy Crinone 8% has been used to support embryo implantation and maintain pregnancies through its use as part of ART treatment regimens in two clinical studies (studies COL1620-007US and COL1620-F01). In the first study (COL1620-007US), 54 Crinone-treated women had donor oocyte transfer procedures, and clinical pregnancies occurred in 26 women (48%). The outcomes of these 26 pregnancies were as follows: one woman had an elective termination of pregnancy at 19 weeks due to congenital malformations (omphalocele) associated with a chromosomal abnormality; one woman pregnant with triplets had an elective termination of her pregnancy; seven women had spontaneous abortions; and 17 women delivered 25 apparently normal newborns. In the second study (COL1620-F01), Crinone 8% was used in the luteal phase support of women undergoing in vitro fertilization (“IVF”) procedures. In this multi-center, open-label study, 139 women received Crinone 8% once daily beginning within 24 hours of embryo transfer and continuing through Day 30 post-transfer. Clinical pregnancies assessed at Day 90 post-transfer were seen in 36 (26%) of women. Thirty-two women (23%) delivered newborns and four women (3%) had spontaneous abortions. Of the 47 newborns delivered, one had a teratoma associated with a cleft palate; one had respiratory distress syndrome; 44 were apparently normal and one was lost to follow-up. Geriatric Use The safety and effectiveness in geriatric patients (over age 65) have not been established. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Nursing Mothers Detectable amounts of progestins have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not been determined. ADVERSE REACTIONS Assisted Reproductive Technology In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Crinone 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women were: bloating (7%), cramps not otherwise specified (15%), pain (8%), dizziness (5%), headache (13%), nausea (7%), breast pain (13%), moniliasis genital (5%), vaginal discharge (7%), pruritus genital (5%).

In a second clinical study of 139 women using Crinone 8% once daily for luteal phase support while undergoing an IVF procedure, treatment-emergent adverse events reported in 5% or more of the women were: abdominal pain (12%), perineal pain female (17%), headache (17%), constipation (27%), diarrhea (8%), nausea (22%), vomiting (5%), arthralgia (8%), depression (11%), libido decreased (10%), nervousness (16%), somnolence (27%), breast enlargement (40%), dyspareunia (6%), nocturia (13%). Secondary Amenorrhea In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Crinone 4% or 8% every other day for six doses. Treatment-emergent adverse events reported in 5% or more of women treated with Crinone 4% or Crinone 8% respectively were: abdominal pain (5%, 9%), appetite increased (5%, 8%), bloating (13%, 12%), cramps not otherwise specified (19%, 26%), fatigue (21%, 22%), headache (19%, 15%), nausea (8%, 6%), back pain (8%, 3%), myalgia (8%, 0%), depression (19%, 15%), emotional lability (23%, 22%), sleep disorder (18%, 18%), vaginal discharge (11%, 3%), upper respiratory tract infection (5%, 8%), and pruritus genital (2%, 6%). Additional adverse events reported in women at a frequency of less than 5% in Crinone ART and secondary amenorrhea studies and not listed above include: autonomic nervous system–mouth dry, sweating increased; body as a whole–abnormal crying, allergic reaction, allergy, appetite decreased, asthenia, edema, face edema, fever, hot flushes, influenza-like symptoms, water retention, xerophthalmia; cardiovascular, general–syncope; central and peripheral nervous system–migraine, tremor; gastro-intestinal–dyspepsia, eructation, flatulence, gastritis, toothache; metabolic and nutritional–thirst; musculo-skeletal system–cramps legs, leg pain, skeletal pain; neoplasm–benign cyst; platelet, bleeding & clotting–purpura; psychiatric–aggressive reactions, forgetfulness, insomnia; red blood cell–anemia; reproductive, female–dysmenorrhea, premenstrual tension, vaginal dryness; resistance mechanism–infection, pharyngitis, sinusitis, urinary tract infection; respiratory system–asthma, dyspnea, hyperventilation, rhinitis; skin and appendages–acne, pruritus, rash, seborrhea, skin discoloration, skin disorder, urticaria; urinary system–cystitis, dysuria, micturition frequency; vision disorders–conjunctivitis. OVERDOSAGE There have been no reports of overdosage with Crinone. In the case of overdosage, however, discontinue Crinone, treat the patient symptomatically, and institute supportive measures. As with all prescription drugs, this medicine should be kept out of the reach of children. DOSAGE AND ADMINISTRATION Assisted Reproductive Technology Crinone 8% is administered vaginally at a dose of 90 mg once daily in women who require progesterone supplementation. Crinone 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require progesterone replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10-12 weeks. Secondary Amenorrhea Crinone 4% is administered vaginally every other day up to a total of six doses. For women who fail to respond, a trial of Crinone 8% every other day up to a total of six doses may be instituted. It is important to note that a dosage increase from the 4% gel can only be accomplished by using the 8% gel. Increasing the volume of gel administered does not increase the amount of progesterone absorbed. This brief summary is based on the current Crinone package insert (Version 40405010007, Revised December 2006). How Supplied Crinone is available in the following strengths: 8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel. NDC-55056-0806-2 - 6 Single-use prefilled applicators. NDC-55056-0818-2 - 18 Single-use prefilled applicators. Each applicator is wrapped and sealed in a foil overwrap. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

A new study confirms the evidence from previous studies suggesting that men who eat foods high in antioxidants can reduce damage to their sperm’s DNA. Infertile men have more sperm DNA damage than fertile men. It is also well-established that sperm DNA damage is associated with elevated levels of very small, oxygen-containing molecules known as reactive oxygen species. Some studies have suggested that a subset of infertile men may be at risk for antioxidant deficiency, particularly vitamin C deficiency. This study reviewed the evidence from available studies on the effects of dietary antioxidant supplementation on sperm DNA quality, concluding that the current evidence supports the beneficial in vitro effects of antioxidant supplementation on improving sperm DNA, even though the exact mechanism of dietary antioxidants has not been established. One of those previous studies shows that vitamin C increases semen vitamin C levels and improves sperm DNA quality in men with vitamin C deficiency. In addition, 5 studies demonstrate that antioxidant therapy improves sperm DNA integrity and/or pregnancy rates. (Zini A, et al. J Assist Reprod Genet. 2009 Sep 19. Epub ahead of print.)

Chlamydia Antibody Levels Linked to Severity of Tubal Damage in Infertile Women Tubal damage in infertile women is associated with a history of chlamydia infection. A new study analyzed the extent of lesions found on laparoscopy and chlamydia antibody titers (CAT) in 408 infertile women with tubal damage. Results showed significant differences in the severity of the lesions— including tubal occlusion and adhesions and type of ovarian adhesions—in relation to CAT. These findings suggest that CAT levels are quantitatively associated with the severity of the tubal damage in infertile women. (El Hakim EA, et al. Arch Gynecol Obstet. 2009 Sep 16. Epub ahead of print.)

Rx only. U.S. Patent Number 5,543,150. Manufactured for: Columbia Laboratories, Inc. Livingston, NJ 07039 Manufactured by: Fleet Laboratories Ltd., Watford, United Kingdom © 2007, Columbia Laboratories, Inc. Printed in USA 6/07 CRI8-XBS-001

Columbia Laboratories, Inc. Livingston, NJ 07039

Parental Age and Level of Male Hormone Best Predictors of IVF Live Births A Chinese study has shown that the 2 factors that best predict live births Continued on page 19

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october 2009 THE OB/GYN AND INFERTILITY NURSE

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From the Editor

Welcome to The OB/GYN and Infertility Nurse Sue Jasulaitis, RN, MS Editor-in-Chief

Some people are always grumbling that roses have thorns; I am thankful that thorns have roses. —Alphonse Karr dissemination of knowledge are critical for keeping abreast of these medical advances and tailoring these advances to nursing care of the specialty patient. Although many fine professional journals are available today, none is entirely focused on the unique needs and challenges of the reproductive nurse. This concept compelled the development of a special journal that comprises all aspects of reproductive nursing. After many months of planning, developing, and designing this new journal, we are excited to share with you the first issue of The OB/GYN and Infertility Nurse—the official publication of the American Academy of OB/GYN and Infertility Nurses. Written by nurses for nurses, this new journal offers a forum for nurses, nurse practitioners, and all others involved in OB/GYN, infertility, and urology to discuss current and emerging diagnostic and therapeutic options relevant to the

he last decade has brought many exciting advances in medicine, notably in the field of reproductive and obstetric medicine. These advances have also brought new challenges to traditional nursing roles, especially in these specialized fields of human reproduction and infertility. The practice of specialty nursing requires a high degree of knowledge and skill, while still encompassing the fundamental commitment to patient care in nursing. Education and

VOL 1, NO

care of our patients, as well as strategies for counseling and follow-up for patients throughout their reproductive years and beyond. Articles in this new journal will provide a wealth of practical and up-to-date information on pertinent and evolving physiologic, medical, and psychological aspects of human reproduction, focusing on the role of the OB/GYN, infertility, and urology nurse in patient care. We invite you to take an active part in this publication, by sharing your thoughts and experience with your colleagues, suggesting topics for discussion, or asking questions to which you have not found immediate answers in your own practice. It is with great pleasure and anticipation that I welcome you to the pages of The OB/GYN and Infertility Nurse and look forward to collaborating with all of you, my special nursing colleagues, in the months to come.

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PUBLISHING STAFF Managing Director Jack Iannaccone jack@infertilitynurse.org 732-992-1537 Editorial Director Dalia Buffery dalia@greenhillhc.com 732-992-1889 Associate Editor Lara J. Reiman lara@greenhillhc.com 732-992-1892 Director, Client Services Russell Hennessy russell@greenhillhc.com 732-992-1888 Mark Timko mark@greenhillhc.com 732-992-1897 Senior Production Manager Lynn Hamilton Business Manager Blanche Marchitto Contact Information: Telephone: 732-992-1892 Fax: 732-656-7938 EDITORIAL BOARD Editor-in-Chief Sue Jasulaitis, RN, MS Clinical Research Manager Fertility Centers of Illinois, Chicago Donielle Abbruscato, RNC Clinical Nursing Manager Brunswick Hills OB/GYN Barbara Alice, MSN, RN, APN-C Nursing Manager, IVF Coordinator South Jersey Fertility Center Monica Benson, BSN, RNC Nurse Manager Third Party Reproduction, RMA New Jersey Kit Devine, MSN, ARNP Advanced Nurse Practitioner Fertility & Endocrine Associates, Kentucky Sandra Fernandez, RPh, PharmD Pharmacist Mandell’s Clinical Pharmacy Jennifer Iannaccone, RNC Nursing Manager IVF Coordinator, IVF New Jersey Donna Makris, RN, BSN, IBCLC Parent Education Coordinator St. Peter’s Medical Center Jill Marchetti, RN Director, Egg Donor Program IVF New Jersey Mary McGregor, RN IVF Coordinator The Fertility Institute of New Orleans Debra Moynihan, WHNP-BC, MSN Women’s Health Nurse Practitioner Carolina OB/GYN Patricia Rucinsky, RN, BSN Clinical Nurse Manager IRMS, St. Barnabas Joan Zaccardi, MS, DrNP Administrative Practice Manager Urogynecology Arts of New Jersey MISSION STATEMENT The OB/GYN and Infertility Nurse is the official publication of the American Academy of OB/GYN and Infertility Nurses. The OB/GYN and Infertility Nurse provides practical, authoritative, cuttingedge information on the physiologic, medical, and psychological aspects of human reproduction, focusing on the role of the OB/GYN, infertility, and urology nurse in patient care. Our journal offers a forum for nurses, nurse practitioners, physician assistants, administrators, researchers, and all others involved in OB/GYN, infertility, and urology to discuss the entire scope of current and emerging diagnostic and therapeutic options, as well as counseling and patient follow-up for men and women throughout their reproductive years and beyond. Written by nurses for nurses, The OB/GYN and Infertility Nurse promotes peer-to-peer collaboration among all nursing professionals toward the advancement of integrated services for optimal care delivery. The journal offers continuing education for all nurses involved in these interrelated fields of patient management.

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CONTENTS

october 2009

Vol 1, no 1

CLINICAL NEWS

Adult Osteoporosis Linked to Low Birth Weight New Analysis Confirms Role of Antioxidants in Sperm DNA 19 Many Australian Infertile Women Not Seeking Help 6

THE UROLOGY NURSE

10 Push for Open Identity of Sperm Donors on the Rise Prostate Cancer Update 11 Frequent Marijuana Use Increases Risk for Testicular Cancer

THE OB/GYN NURSE

12 When to Refer the Patient to an Infertility Center Many Women Still Ignore Risk of Alcohol in Pregnancy

NUTRITION

13 Lycopene May Be Beneficial for Sperm and Egg PHARMACY CORNER

14 Consider Latex Allergy When Dealing with Infertility Medications REPRODUCTIVE RESOURCES

15 Growing Use of Newborn Umbilical Cord Blood in Regenerative Medicine

THE INFERTILITY NURSE

16 Third-Party Reproduction Coordinator Educate Patients on the Benefits of Single-Embryo Transfer 17 New Techniques Using Polar Bodies Screening Enhance Genetic Diagnosis

THE OB/GYN & INFERTILITY NURSE

20 Polycystic Ovarian Syndrome: Medical and Reproductive Implications THE CANCER PATIENT

22 Fertility Preservation before Cancer Treatment Drugs that Increase BMD Important for Bone Health in Breast Cancer

OBESITY & REPRODUCTION Courtesy of Dr Alfred Senn

24 Effects of Overweight/Obesity on Fertility Bariatric Surgery May Have Reproductive Impact

ASRM MEETING HIGHLIGHTS

26 Multidisciplinary Approach to Patients with HIV Provides Reproductive Services Common Household Contaminant May Affect Fertility

The OB/GYN and Infertility Nurse is published 6 times a year by Greenhill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831. Copyright ©2009 by Greenhill Healthcare Communications, LLC. All rights reserved. The OB/GYN and Infertility Nurse is a trademark of Greenhill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America. The ideas and opinions expressed in The OB/GYN and Infertility Nurse do not necessarily reflect those of the Editorial Board, the Editors, or the Publisher. Publication of an advertisement or other product mentioned in The OB/GYN and Infertility Nurse should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the Editors nor the Publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issue, $17.00. Orders will be billed at individual rates unless proof status is confirmed. SUBSCRIPTIONS/CHANGE OF ADDRESS should be directed to CIRCULATION DIRECTOR, The OB/GYN and Infertility Nurse, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831; Fax: 732-656-7938.

october 2009 THE OB/GYN AND INFERTILITY NURSE

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Clinic Profile IVF New Jersey... Continued from page 1 I look for a nurse who is willing to learn, compassionate, empathetic, a good “hand holder,” a good listener, and one who likes to give hugs. After interviewing a potential employee, I encourage the candidate to review the literature on reproduction medicine, including basic anatomy, menstrual cycle, and hormone levels. Reviewing our IVF websites is also very useful. Most important, the nurse should understand that the world of infertility is challenging, exciting, and rewarding.

Jennifer Iannaccone, RN

discussed in an anatomy and physiology course; however, a nurse new to the field of infertility has much to learn.

In your role as clinical manager at a busy IVF center, what are you looking for in a prospective infertility nurse? After assisting in the delivery of thousands of babies for 20 years as a delivery room nurse, I began my career in infertility 10 years ago. In my role as clinical manager in charge of hiring nurses, I look back on these first days and months to find ways to smooth the transition of nurses into the world of infertility. With my extensive nursing experience, I had anticipated that working in an infertility center would be easy. After months of orientation, hundreds of questions, and many frustrating moments, I can now say that there is nothing more rewarding than working with a couple struggling to start a family and being able to congratulate them with a positive pregnancy test. This is what the field of reproductive nursing is all about. But it is also a very challenging area for nurses and requires certain qualities.

What are the steps to introducing a nurse to infertility? It is helpful to provide the new nurse a packet with information that reviews specific protocols, procedures, and pa tient consents specific to the IVF clin-

Each day should start with a brief review of the previous day’s information and any questions the new nurse has. Allow 1 hour each day for a discussion of a new concept, and the remainder of the day should be devoted to “hands-on” procedures, and a review at the end of each day. ic. On the first day, the new nurse should be assigned a preceptor for the duration of her orientation. A preceptor must be knowledgeable, dependable, warm, and patient. Because we all learn in a different way, some may require more time than others to grasp a certain concept. The preceptor should encourage questions and should not set a time limit for the orientation. When concepts are grasped, progress is made. The new nurse should understand that she will shadow her preceptor during orientation, and should be encouraged to take notes for future reference. She should be given a timeline, which will outline information to be reviewed each

Nurses inside IVF New Jersey (from left): Leslie Meincke, Cathy Ovacz, Patrice Cote, Jill Marchetti, Jamie omas, Ella Roychowdhury, Jennifer Iannaccone, Zoﬁa Mancera, Lauren Noble, Terri Nelson.

day, along with expectations. The preceptor should assess the knowledge level of the new nurse and help to build on it. Each day should start with a brief review of the previous day’s information and any questions the new nurse has. Allow 1 hour each day for a discussion of a new concept, and the remainder of the day should be devoted to “hands-on” procedures, and a review at the end of each day. Begin with the “basics,” such as review of the reproductive cycle, hormone levels, infertility testing, IUI, IVF cycles, egg donor rules, and so on. The nurse should spend some time in the embryology and andrology laboratories and with the donor egg team. In addition, the new nurse should

THE OB/GYN AND INFERTILITY NURSE october 2009

observe the physician during an initial consultation with an infertility couple or patient. Once comfortable with the concepts, the nurse will need to have an orientation in the recovery and operating room.

Could you elaborate a bit on the challenges? Infertility is a very challenging field of nursing, because it is forever and rapidly changing. I have been in this field for 10 years and have seen enormous advances during that time. That means that we are constantly learning new information and new procedures. There are many things we do today that were not done when I moved into this field. One example is preimplantation genetic diagnosis, which is becoming more and more common today but was on the horizon only 10 years ago. In addition, we are treating more patients at our center than before, and we are much busier than we were 10 years ago. IVF New Jersey is a large center that is constantly growing, but this may also be the case in other centers, in part because some states now mandate infertility coverage, which removes some of the cost barriers for couples. All this means we have to acquire a new set of skills and a lot of information that is not yet being taught in nursing programs. We also have to know about infertility and other drugs

used in this field; at our clinic, although the doctor prescribes the dose of a medication, the nurse chooses the specific drug and orders it, which can be challenging. This is why having a clear transitioning plan for the new nurse is so important. Finally, many times patients ask the nurse questions before they go to the physician, because as patient advocates, we do spend a lot of time with patients.

Do nurses work with the couple at any point? At our clinic we work with the couple as a unit. When a couple comes in for the initial visit, we do screening blood work on the patient and her partner. In addition, our andrologist will do a semen analysis to rule out a male factor, which is the cause of infertility in approximately 40% of the cases. In the event that this is the case, the man will be referred to a reproductive urologist for further evaluation. Clearly, the infertility nurse will interact with the woman and her partner to some extent in any event.

Do you have any final tips for the nurse who is new to the field of infertility? Having experience in OB/GYN is beneficial for a nurse who is entering the field of infertility, but it is not a must. It may be a coincidence, but I have found that many nurses who have previously worked in labor and delivery eventually transition to infertility. Nurses are notorious for placing too much stress on themselves. We all have our own way of learning, some by repetition, some learn visually, and others by hands on. Take each day as a new learning experience. Seize the moment, and it will happen. If you are interested in infertility, you will find it very rewarding. ■

Share Your Questions with Colleagues We invite you to share your professional questions with your colleagues and have them discussed on the pages of The OB/GYN and Infertility Nurse. Ideally, your question would reflect an issue you have encountered in your practice that may be of interest to other OB/GYN, infertility, or urology nurses. Fax: 732-656-7938 E-mail: lara@greenhillhc.com

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Emerging Questions How Should We Advise Pregnant Women... Continued from page 1

Donna Makris, RN, BSN, IBCLC

their expectant families on this subject. In July, the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices announced that pregnant women should be the first group to receive the H1N1 flu vaccine once it becomes available. The following groups of individuals are at risk for the H1N1 influenza virus: • Individuals with an underlying medical condition • People younger than age 25 years • Children • Pregnant women. As we well know, during pregnancy many soon-to-be mothers are very cautious about what they consume and what medication they take. Expectant mothers should be advised that early intervention against the H1N1 flu virus is extremely important.

fetus, leading to intrauterine growth restriction and preterm labor, in addition to the serious risk to the expectant mother. These are only some of the potential problems that could occur when a pregnant woman has the H1N1 flu. An increased risk during pregnancy is now well-documented across the country. The CDC has recently published information on 3 cases of H1N1 virus infection in pregnant women (MMWR. 2009;58:497-500). The CDC notes that during seasonal flu epidemics, pregnant women have been at increased risk for complications. It is now known that adults of reproductive age and children are more susceptible to the H1N1 flu virus than the general population. Because the current recommendation is not to vaccinate infants until they are 6 months old, vaccinating expectant mothers could have added benefits and may even provide some protection for the newborn. Vaccination Priorities The CDC’s Advisory Committee’s recommendations for H1N1 flu vaccination programs are different from the seasonal flu vaccination program. The CDC issued the following vaccination priorities for the H1N1 flu vaccine: 1. Pregnant women 2. People who live with or care for children <6 months old 3. Healthcare and emergency services personnel 4. Babies, children, and young adults ages 6 months to 24 years 5. Adults aged 25 through 64 years who are at increased risk for the novel H1N1 infection because of

One of the complications of the H1N1 flu is acute respiratory illness with rapidly progressing severe pneumonia. Pneumonia can potentially also alter the oxygen flow to the developing fetus, leading to intrauterine growth restriction and preterm labor, in addition to the serious risk to the expectant mother. Complications in Pregnancy Providing protection for a pregnant mother is critical. During pregnancy, the woman’s altered immune system may make her more vulnerable to a host of complications. Receiving the H1N1 flu vaccine should be a high priority for any expectant mother carrying a baby or having a baby this fall. One of the complications of the H1N1 flu is acute respiratory illness with rapidly progressing severe pneumonia. Pneumonia can potentially also alter the oxygen flow to the developing

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chronic medical disorders or a compromised immune system. Public health officials indicate that a vaccine should be available by midOctober and they advise people to check with their state health department and the CDC website for updates (www.cdc.gov/H1N1flu). In August, the federal government began testing H1N1 flu vaccine in volunteers around the country to prepare for a voluntary mass vaccination campaign in the fall. Various clinical trials are currently being conducted under the

H1N1 inﬂuenza virus

direction of the National Institutes of Health. The United States has a long history of developing safe and effective vaccines. The government will continue to monitor the safety of any approved H1N1 flu vaccine throughout the upcoming vaccination effort.

Although vaccination is voluntary, it is highly recommended for pregnant women. This year, it is essential that certain groups of individuals protect themselves against the H1N1 flu virus in addition to the seasonal flu. A seasonal flu shot will improve people’s immune system and reduce hospitalizations and emergency department visits. About 36,000 Americans die annually from complications of the seasonal flu. As with any flu strain, the most effective form of prevention is vaccination. In addition to vaccination, other precautions should be taken to prevent the spread of infection: washing hands thoroughly and frequently, covering the mouth while coughing and sneezing, and staying home when sick. Unknown Factors Although the H1N1 flu virus was recorded as mild during the spring and summer months in the United States, flu is one of the most unpredictable communicable diseases, and the H1N1 flu may reemerge in a stronger form later in the year. Public health officials expect that during the winter, the rate of the H1N1 flu cases can increase significantly, and they strongly advocate vaccinating those at risk, starting in October. Because this is a new strain of flu virus, we will not know how serious the risk is until far into the winter.

According to the CDC, pregnant women have accounted for 6% of deaths nationwide from the H1N1 virus, even though only 1% of the H1N1 flu cases occurred in pregnant women. Although vaccination is voluntary, it is highly recommended. The benefits of vaccination far outweigh any perceived risks. This fall it is critical that all healthcare professionals stress the importance that pregnant women receive the H1N1 flu vaccine. All healthcare professionals also need to remain informed about any developments with the H1N1 flu. ■

New Clinical Trial to Test H1N1 Flu Vaccine in Pregnancy The first clinical trial investigating the efficacy of an investigational H1N1 flu vaccine in pregnant women was launched in September 2009. Pregnant women represent the most susceptible population to this novel flu strain. The trial is conducted by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health. The H1N1 flu vaccine used in this trial is produced by Sanofi Pasteur, one of several vaccines currently in development for this variant. The trial will engage 6 sites across the United State and will enroll up to 120 pregnant women, ages 18 to 39 years, who are in their second or third trimester of pregnancy. Blood samples will be tested before and after vaccine administration, and umbilical blood cord will be collected to evaluate the antibodies that are being transferred from the expectant mother to the fetus, according to the NIAID.

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Clinic Spotlight Fertility Centers of Illinois... Continued from page 1 lecture on nursing is that the physician creates the medical treatment plan, but it is up to the nurse to implement it. The beauty of nursing is that we can implement the plan in a way that adds

This is how every nurse could bridge the gap into research, by reviewing your own population and seeing if there are patterns of care that may not be desirable.

Embryologist performing intracystoplasmic sperm injection procedure.

and caring services can provide. We routinely offer single-embryo transfers to our patients to enhance patient outcomes and reduce multiple pregnancies. Our embryology laboratories feature the most advanced equipment, the latest research applications, and a team of highly skilled professionals who have extensive clinical experience. FCI performs more than 3000 IVF cycles yearly, and has had more babies born than the next 10 fertility clinics in the Chicago area combined. A unique aspect of FCI is our commitment to infertility research, including pharmaceutical and product research. We routinely conduct clinical trials of new medications and procedures designed to improve the care of patients with reproductive needs. In my role as clinical research manager, I personally conduct these trials. In addition, our center evaluates new research questions with the goal to develop novel and innovative treatments. Nursing has a significant impact on the quality of care provided to our patients. Our direct commitment to quality care is what allows us to stand apart from other professions. I encourage nurses to use their specialty knowledge to generate questions for research based on their daily experience with patients. These research questions can vary from patient satisfaction to clinical outcomes with different treatment protocols. The critical part in research is knowing what questions to ask. Once we ask the right questions, looking for the answers through the research process is easy.

accident” by joining a friend who owns a research company. Since my background was infertility, my goal was to initiate a number of infertility studies. At that time, infertility research was sparse. Missing fertility nursing, which was my first interest, I came back to work “in the trenches,” as we call it. Gradually, as funding for infertility research became more common, and new medications were being developed to enhance fertility treatment, our center began participating in clinical trials. From there, we started to look at the specific treatment protocols within our own practice, and began to focus on how we could improve patient outcomes. We started by identifying problem areas that were not being addressed. We realized that we could use our database to look not only at the individual patient but also at our entire population to see if a problem we encounter in one patient is an isolated incident or could be relevant to other patients as well. One of the things I always say when I

quality to patient care. Nursing allows us a unique perspective to identify areas where improvement in clinical practice is needed. As nurses we make the biggest difference in the patient’s journey through medicine, be it fertility or another medical area, in the way we approach a

problem area and work through the stages of medical therapy. This is what we nurses do well. I see research as an extension of that type of patient care. I started looking at my own patient population and realized that if I am seeing this in my patients, it is probably a widespread problem. And this is how every nurse could bridge the gap into research, by reviewing your own population and seeing if there are patterns of care that may not be desirable, where improvement could be made. For example, you may notice that several patients have a miscarriage and they are all using the same medication, or maybe patients are complaining about a drug because it burns when administered. These could be questions for research that will help us improve patient care.

This is fascinating. You ask nurses to get involved in research because their daily experience with their Continued on page 9

River North IVF embryology team (from left): Sara Sanchez, Rebecca Brohammer, Andrew Barker, Juergen Liebermann, Jill Mathews, Amanda Erman, Elissa Pelts, Yuri Wagner.

How did you get involved in research, and how does it fit the model of the infertility nurse? After switching from a hospital nurse to infertility nursing more than 15 years ago, I became involved in research “by

An inside look at River North IVF Center’s embryology laboratory.

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Clinic Spotlight Fertility Centers of Illinois... Continued from page 8 individual patients could help others and improve patient care? Yes, nurses have the power to improve patient care by asking questions that will guide research and will ultimately improve patient care. You are right; as nurses we start at the ground

level and work our way up, because that tells us what questions to investigate. Many nurses are afraid of research, but there is so much we could do to improve patient care just by reporting what we are seeing on a daily basis. That is probably my main message to

nurses. We are the ones who ask the questions, and by asking the questions we can push medicine to another level and establish a plan for following through to study those issues. We do not have to be responsible for the statistical analysis of any study, but can be respon-

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sible for asking the questions based on our daily experience. Another aspect of my role is quality control and quality assurance. In that capacity we have just initiated a “quality improvement suggestions” program. I have asked all our nurses and other interdisciplinary team members, who know where the problem areas lie, to report any problem they are seeing in their own department. This can be a problem we are not aware of from a systemwide perspective. In addition to reporting the problem area, we ask the staff to suggest a solution or an action plan to correct or facilitate a solution. For example, if nurses identify several patients that have difficulty administrating a specific medication, we ask them to report that and suggest a solution or an action plan. Suggesting a solution gives the nurse ownership of that problem. Some of those identified

I urge all nurses to... send their questions to the journal, to share their experience with others and see if they have similar problems or solutions.

FOCUS ON Reproductive Nursing: OB/GYN, Urology, Infertility Clinical Updates: Diagnostic and Treatment Options Chronic Diseases, Aging, Fertility

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Physiology/Psychology of Human Reproduction Nutrition, Sexuality, Drug Therapy Continuing Education for Nurses

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problem areas can then lead to research. A major difficulty in research is what questions to ask. If we could figure out the right questions, we could review the system or the population and see if it is a recurrent problem. If we find that it is a common problem in our center, there is a good chance that it is a problem at other centers, locally or nationally. One of our studies currently being prepared for publication is based on a problem we identified at FCI involving luteal bleeding (bleeding between the time of egg retrieval/insemination and pregnancy test) and what medications may be associated with increased bleeding. After reviewing the literature, we realized that no one had asked that question in relation to the new medication therapies. Everyone, and every infertility nurse, has encountered this problem, but no one has asked the question. I urge all nurses to start asking questions, and even send their questions to the journal, to share their experience with others and see if they have similar problems or solutions, or if they could instigate new research ideas. The beauty of nursing lies in the implementation of quality in patient care. ■

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The Urology Nurse

Push for Open Identity of Sperm Donors on the Rise s many as 33% of young adults who were conceived with donor sperm express a desire to know the identity of their sperm donor, and 50% of those receiving this information make an effort to meet the man in person, according to Joanna Scheib, PhD, Professor of Psychology, University of California, Davis. Currently, most American sperm donors are still anonymous, but identity-release programs are on the rise, and increasing numbers of programs in the country now offer this option to offspring who reach adulthood. Dr Scheib was the lead author of what appears to be the world’s first study on the subject. She reported the results of that study last year during the 2008 annual meeting of the American Society of Reproductive Medicine.

The landscape is changing, Dr Scheib says, as some European countries have legislated against anonymous sperm donation altogether, and pressure is building in the United States to eliminate anonymity. Her study included 142 offspring, ages 18 years through 25 years, conceived through the open-identity sperm donor program called Identity Release at the Sperm Bank of California. Of the 125 offspring in the study who were informed about their means of conception, 39 (30%) chose to learn their donor’s identity; the majority of those who wished to learn the donor’s identity were 18 years old. Female sex and family structure were influential in choosing to know their sperm donor. Participants raised by a single mother made 44% of the requests

for donor identity, and “at least half of the adults went on to contact and meet their donor,” according to Dr Scheib.

Some European countries have legislated against anonymous sperm donation altogether, and pressure is building in the United States to eliminate anonymity. The desire for sperm donor identity was even greater in a separate study from Houston Baptist University, Texas, of 85 participants from an online support group for donor-conceived off-

spring: 90% had received no identifying information about their donor, although the same percentage expressed a desire for it, and 60% believed that all sperm donation should include identity information, according to Patricia Mahlstedt, EdD, a psychologist in private practice in Houston. Dr Mahlstedt said the study participants hoped that providers (sperm banks, physicians, nurses) would come to regard sperm donation as a positive option that did not require secrecy, and would encourage the use of donors who allow their identities to be revealed. Although about 40% of participants reported feeling “good” or “very good” about the means of their conception, approximately 30% said they felt “bad” or “very bad” about it. ■ —Caroline Helwick

Prostate Cancer Update rostate cancer is the most common solid tumor diagnosed in American men and the second leading cause of cancer-related death in men, according to the American Cancer Society. Although treatment choices for prostate cancer have not made as many strides as some other types of cancer, significant progress has been made in the diagnosis of patients at high-risk for prostate cancer. In addition, significant advances have been made in the approach to prostate cancer prevention for men with this disease, even for those with metastatic disease.

Diagnosis Progress has been made in the assessment of risk for prostate cancer in identifying single-nucleotide polymorphisms in 3 independent chromosomal regions—8q24, 17q12, and 17q24.3. This genetic information, together with a family history of prostate cancer, now allows clinicians to assess a man’s relative risk of being diagnosed with prostate cancer more accurately. Prevention Much evidence over the past few years supports the use of 5 mg/day of finasteride for the prevention of prostate cancer in men at high risk for this disease, especially African Americans or those with a family history of prostate cancer. Although finasteride has not yet been approved by the FDA as a chemopreventive agent, evidence supports the off-label clinical use of this agent for men at high risk for this disease.

Diet Several dietary supplements have been investigated for the prevention of prostate cancer. The recently published Selenium and Vitamin E Cancer Prevention Trial (SELECT) showed that neither vitamin E nor selenium, used alone or together, provides clinically significant benefit in this context. Treatment Information gleaned from the Surveillance, Epidemiology, and End Results program on the management of localized T1 and T2 prostate cancer showed no survival benefit at 10 years for androgen-deprivation therapy (ADT) compared with conservative management. In addition, some studies have shown an increased risk with ADT use for certain complications, including myocardial infarction, diabetes, and fractures. The evidence for the superiority of one treatment choice over another is lacking, but a recent study showed that radiation therapy within 2 years of cancer recurrence after radical prostatectomy offers a significant survival benefit compared with no salvage treatment. Abiraterone acetate—which inhibits the production of testosterone in the testis, the adrenal glands, and the prostate—has been shown to be less toxic than ketoconazole for men with metastatic prostate cancer. Prednisone is currently being investigated in phase 3 clinical studies that show further reduction of the incidence of mineral corticoid excess.

Carefully assessing risk, implementing preventive measures, educating patients on available treatment options, screening for clinical trial eligibility, and continual PSA monitoring are all within the clinical nurse arena.

Clinical Implications Prostate-specific antigen (PSA) continues to be the measure of response used for prediction of overall survival in men with prostate cancer. Carefully assessing risk, implementing preventive measures, educating patients on available treatment options, screening for clinical trial eli-

gibility, and continual PSA monitoring are all within the clinical nurse arena. Implementing current guidelines in clinical practice, and following evidence from published studies will enable nurses to prevent the disease, delay disease progression, and improve survival for men with prostate cancer. ■

New Vaccine Improves Survival for Men with Prostate Cancer

ccording to results of the phase 3 study—Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT)—which was presented at the 2009 annual meeting of the American Urological Association, a new vaccine that activates the im mune system against prostate cancer extends life by a median of 4.1 months in men with advanced prostate cancer. The vaccine, called sipuleucel-T (Provenge), represents the first active immunotherapy that has demonstrated improvement in survival of men with

advanced prostate cancer. The IMPACT study is the third trial that demonstrated a survival benefit with this vaccine and has the potential to create a new treatment paradigm in the management of men with prostate cancer, experts suggested at the meeting. In IMPACT, 512 men with metastatic, castrate-resistant prostate cancer were randomized to receive the vaccine or placebo in a 2:1 ratio. The median survival was 25.8 months with sipuleucel-T compared with 21.7 months in the placebo group. Continued on page 11

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The Urology Nurse

Frequent Marijuana Use Increases Risk for Testicular Cancer he incidence of testicular cancer has been on the rise in the past 4 to 6 decades, but the cause for this has not been known. Now findings from a new study (Daling JR, et al. Cancer. 2009;115:1215-1223) indicate an association between marijuana useâ&#x20AC;&#x201D;which also increased in the past few decadesâ&#x20AC;&#x201D;and the incidence of testicular cancer. The study compared 369 American men ages 18 to 44 years who were diagnosed with testicular cancer between 1999 and 2006 and 979 age-matched controls, all from 3 counties in Washington State. Those who had testicular cancer were more

likely to be current marijuana users compared with the controls. Age at first use among current users (<18 years) and frequency of use (daily/ weekly) appeared to increase the risk of cancer. Previous studies have shown that regular and frequent use of marijuana affects the human endocrine and reproductive system, and specifically in men it has been linked to reduced testosterone levels, lower sperm quality, and impotence. Stephen M. Schwartz, PhD, MPH, of the Public Health Sciences Division at Fred Hutchinson Cancer Research Cen -

Male Factor Infertility Linked to Testicular Cancer Risk

esults of a new study conducted over many years and involving 15 infertility centers in California show a direct connection between male factor infertility and testicular cancer, suggesting that these 2 conditions share common causes. In the past 3 to 5 decades, the rate of testicular cancer incidence has increased in industrialized countries, along with a decrease in semen quality and male fertility. Previous studies that have investigated a potential link between male infertility and testicular cancer have shown inconsistent results. For this new study, an initial cohort of 51,461 couples was recruited from 15 infertility centers between 1967 and 1998. Data on 22,562 male partners (44% of the couples) were linked to data identified in the California Cancer Registry. The incidence rate of testicular cancer in the 22,562 men was compared with the incidence rate in an age-matched cohort from the general population in California. Men who were identified with testicular cancer within 1 year of being evaluated for infertility were excluded from the analysis. Using semen analysis, male factor infertility status was identified for 19,106 of the men in the 22,562 cohort, showing that: â&#x20AC;˘ 4549 men had male factor infertility

(24% of the 19,106 cohort) â&#x20AC;˘ 14,557 men did not have male factor infertility (76% of the 19,106 cohort). During the study period, 67 cases of testicular cancer occurred in the entire cohort, of which only 34 occurred at least 1 year after the start of an infertility evaluation. These results show that the risk of developing testicular cancer is 3-fold greater in men with male factor infertility than in those without male factor infertility.

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tective process of the chemical that resembles marijuana. Nurses who are dealing with adoles-

â&#x20AC;&#x153;Our study is not the first to suggest that some aspect of a manâ&#x20AC;&#x2122;s lifestyle or environment is a risk factor for testicular cancer, but it is the first that has looked at marijuana use.â&#x20AC;? â&#x20AC;&#x201D;Stephen M. Schwartz, PhD

factor for testicular cancer, but it is the first that has looked at marijuana use.â&#x20AC;? Menâ&#x20AC;&#x2122;s reproductive system is known to produce a cannabinoid-like chemical that is believed to protect against cancer. In their study, Daling and colleagues hypothesized that marijuana use could be interfering with this pro-

cent boys may now be able to use this information as one more weapon against marijuana use at a young age, by emphasizing that not enough is known about the deleterious long-term effects of marijuana use, especially during the susceptible age of hormonal changes in teen-aged boys. â&#x2013;

If you knew something that might save a life, wouldnâ&#x20AC;&#x2122;t you want to share it with your patients?

The risk of developing testicular cancer is 3-fold greater in men with male factor infertility than in those without male factor infertility. This study confirms findings from previous studies that have shown an association between testicular cancer and infertility. In addition, these findings link for the first time the presence of male factor infertility and the increased risk for the development of testicular cancer. The study was published in February in the Archives of Internal Medicine (Walsh TJ, et al. 2009; 169:351-356). â&#x2013;

New Vaccine... Continued from page 10 The 3-year survival was improved by 38% in the vaccine group. This immunotherapy is delivered in 3 sessions over 4 weeks. The therapy does

ter in Seattle, noted, â&#x20AC;&#x153;Our study is not the first to suggest that some aspect of a manâ&#x20AC;&#x2122;s lifestyle or environment is a risk

not interfere with the daily activities before or after the therapy session. Side effects reported were mild in the vaccine group compared with placebo. â&#x2013;

Saving umbilical cord blood stem cells is a once-in-a lifetime opportunity that can be lifesaving to your patients. Cord blood stem cells have been saving lives for more than 20 years and have been used to treat nearly 80 serious diseases. In fact, they are showing significant potential to treat conditions that have no cure todayâ&#x20AC;&#x201D; like juvenile diabetes and brain injury. Make sure your patients learn about saving cord blood with Cord Blood Registry,ÂŽ the #1 choice of Ob/Gyns and expectant families.

View our cord blood education program at:

cordblood.com/educate New uses for cord blood stem cells are being discovered rapidly; however, banking cord blood does not guarantee that the cells will provide a cure or be applicable for every situation. Ultimate use will be determined by the treating physician. Use in regenerative medicine is still CONSIDERED EXPERIMENTAL 3OURCE FOR /B 'YN CLAIM "LIND SURVEY 'F+ -ARKET -EASURES ÂĽ #BR 3YSTEMS )NC s s -!

october 2009 THE OB/GYN AND INFERTILITY NURSE

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The OB/GYN Nurse

When to Refer the Patient to an Infertility Center Debra Moynihan, WHNP-BC, MSN Carolina OB/GYN

nfertility should be considered when the patient states that she has been trying to conceive without success for a period of 1 year if she is younger than 35 years. If she is older than 35, she should be advised to seek assistance after 6 months of unprotected intercourse. In most cases, the first stop for the majority of these patients is the OB/GYN office, which appears to be their comfort zone.

Ask Questions Early My best advice for nurses who work in OB/GYN nursing is to ask every new patient who is at least 25 years old about her childbearing plans. Many women seek routine care year after year, and this topic is never discussed. Then at a routine check-up around age 39 or 40 she says she is contemplating starting a family, and she is horrified to learn that it may be a challenge. Many women are still unaware that the biological clock is ticking. Educating our patients is the first step in the childbearing journey. Biologically, the best time to have a baby is in the 20s, but many women are not ready to conceive then, for various reasons—school, career building, fi-

Patient Information

nances, or lack of a lifetime partner. The “perfect” time to conceive is up to the individual and her partner, not the healthcare provider. But it is our responsibility to provide her with concrete information about fertility and the aging process. Once she is ready, it is our privilege to either help her in the journey or provide her the care she needs if she accomplishes the task on her own. The 3-Month Threshold When the patient comes into the OB/GYN office seeking assistance, usually the first things discussed are the menstrual cycle and ovulation. Some offices, even today, discuss the basal body temperature method. Depending on the age of the patient, this could be a misuse of valuable time.

Many women are still unaware that the biological clock is ticking. Educating our patients is the first step in the childbearing journey. Using an ovulation predictor kit may be more costly for the patient, but it is a very useful tool. A trial of 3 months should be long enough to evaluate the woman’s cycle. If she is anovulatory, the gynecologist will most likely recommend trying clomiphene (Clomid). This is a noble entry into treatment,

but if a pregnancy is not achieved after 3 months, the patient needs to move on. But many OB/GYNs tend to keep these patients under their wings, promoting the use of clomiphene for 6 to 12 months. Generally, if a pregnancy is not achieved within 3 months, the patient will require more aggressive treatment. Depending on the patient’s age, time may be of the essence. This is when the patient should be referred to a reproductive endocrinologist. Some gynecologists do a preliminary work-up on the woman, such as a hystersalpingogram and/or blood tests. They may also ask the patient’s partner to have a semen analysis done. If the partner agrees, the OB/GYN office should explore the use of laboratory services at a local infertility center, rather than a commercial laboratory or hospital, to ensure the accuracy of the semen analysis. It also increases the patients’ awareness of the existence of such centers and helps them get their foot in the door faster. Reproductive Endocrinology Remember that some patients have special circumstances, such as being past menopause, patients with cancer who have had chemotherapy, or women without a uterus. But these patients are not without hope; they need a referral to a reproductive endocrinologist, who will offer services, such as donor eggs or gestational

In addition to offering treatment, nurses may suggest some educational tools to their patients, including: • Conceive Magazine is a wonderful resource for patients attempting pregnancy, offering up-to-date, factual information. In its section “Ask the Experts,” 2 reproductive endocrinologists answer complicated questions about achieving pregnancy. • An easy-to-navigate website for patients—www.fertilitylifelines.com— helps patients in locating a fertility center near them. These tools will also increase patients’ awareness of the need to seek specialized care to achieve their dream.

carriers. Reproductive medicine has made great strides over the years. In some cases, finances may be an obstacle, but 15 states now have mandates that insurance must cover infertility treatment. The list is slowly growing; in the meantime, you can still encourage your patients to seek the treatment they need. Many infertility centers offer discounted fees for patients without coverage, and pharmaceutical companies offer discounted programs for necessary medications that are part of the treatment. Help is always available. Although the intentions of the OB/GYN clinics are sincere, patients’ needs will best be served in the hands of the reproductive endocrinologist when trying to achieve pregnancy. ■

Many Women Still Ignore Risk of Alcohol in Pregnancy

Figure Alcohol Consumption During Pregnancy, 1991-2005 60 50 Any use, not pregnant Binge drinking, not pregnant Any use, pregnant Binge drinking, pregnant

40 Percentage

recent article published in May 2009 by the Centers for Disease Control and Prevention (CDC) warns that too many pregnant women in the United States still drink alcohol during pregnancy (MMWR. 2009;58: 529-532), despite the well-known risks to the fetus, which many OB/GYN nurses and physicians may now be taking for granted. The study surveyed 533,506 women between 1991 and 2005, including 22,000 women who were pregnant during this period. The surprising results showed that pregnant women were still consuming as much alcohol in 2005 as in 1991 (Figure). A total of 12.2% of the pregnant women reported drinking once or more during their pregnancy, and 1.9% of the pregnant women surveyed reported binge drinking—at least 5 drinks on the same occasion—which may surprise many of those involved in patient care for pregnant women. A larger percentage (17.4%) of the older women (those aged 35 - 44 years) were drinking

30 20 10 0 1991

1993

1995

1997

1999

Year Source: MMWR. 2009;58:529-532.

2001

2003

2005

during pregnancy than younger women (8.6%) aged 18 to 24 years. Age itself did not appear to influence binge drinking. Almost twice as many pregnant women who are employed reported alcohol use as unemployed pregnant women. The report shows that among pregnant women, those who are more educated, employed, and unmarried are more likely to use alcohol during pregnancy compared with those who are less educated, unemployed, and married. The reasons for these differences are not clear and need to be further investigated. The CDC reiterates that alcohol use during pregnancy continues to be an important public health concern. OB/GYN nurses and other clinicians may need to increase their efforts at educating pregnant women about the risks of alcohol consumption during pregnancy and not assume that this is by now well known. The CDC also recommends that providers enhance their screening for alcohol use during pregnancy as a preventive measure. Continued on page 13

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Nutrition

Lycopene May Be Beneficial for Sperm and Egg he antioxidant lycopene found in some foods may exert positive effects on human sperm as well as eggs, according to preliminary research. Lycopene is found in tomatoes and some other foods, and has previously been touted as a possible chemopreventive agent in certain types of cancer. Two recent studies have investigated the potential benefits of lycopene for fertility. In the first study, investigators hypothesized that since oxidative stress can be harmful to sperm, the antioxidant properties in lycopene may provide protection to sperm quality. The experiment included sperm from documented fertile donors that was preincubated in solutions with and without lycopene and then exposed to hydrogen peroxide to induce DNA damage. Sperm samples that had been pretreated with lycopene solution demonstrated less damage than the untreated samples, according to Jamie Libman, MD, with McGill University, Montreal, Canada. Incubation with hydrogen peroxide (50 µM) resulted in a significant decline in mean percent sperm motility and a significant increase in percent DNA fragmentation index (DFI) compared with samples incubated without hydrogen peroxide. Pretreatment of samples with 5-µM lycopene resulted in a significantly lower percent DFI compared with untreated samples (8% vs 30%), although lycopene did not protect sperm from the observed decline in motility. In the other study in women, researchers showed that lycopene substantially reduced levels of adhesionrelated markers in normal peritoneal and adhesion fibroblasts.

Reactive oxygen and nitrogen species play an important role in the development of the adhesion tissue phenotype. Specifically, adhesion fibroblasts seem to have increased levels of type 1 collagen, vascular endothelial growth factor, and transforming growth factor-beta-1,

which may be reduced by an antioxidant, according to Tarek Dbouk, MD, from Wayne State University, Detroit, and colleagues. Adhesion tissue that was soaked in lycopene for 24 hours had significantly reduced mRNA levels of all of these

proteins. Although further investigations are needed to determine if adhesions and fibrosis would also be reduced, investigators suggested this could be a first step in a molecularly targeted therapeutic intervention for fibrosis. ■ —Caroline Helwick

got Mandells? Enter for a chance to win $250.00 Log on to MandellsClinicalPharmacy.com Email the answer to this question through our website and you’re in!

Many Women Still... Continued from page 12

Alcohol consumption during pregnancy is associated with an increased risk for poor birth outcomes, including: • Fetal alcohol syndrome • Birth defects • Low birth weight.

Pregnant women were still consuming as much alcohol in 2005 as they did in 1991.

What year did Terry and Eddie purchase Mandells?

Answers will be forwarded to The OB/GYN and INFERTILITY NURSE publication where a winner will be randomly selected.

Binge drinking is especially harmful for fetal brain development. The CDC’s Healthy People 2010 objectives include increasing the rate of pregnant women who abstain from alcohol consumption to 95%, and increasing the rate of those abstaining from binge drinking to 100%. ■

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october 2009 THE OB/GYN AND INFERTILITY NURSE

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Pharmacy Corner

Always Consider Latex Allergy When Dealing with Infertility Medications

he term “natural latex” refers to a product manufactured from a milky substance taken from the rubber tree. Latex allergy is a reaction to specific proteins in latex rubber that can progress rapidly and unpredictably in susceptible people who will have adverse consequences. The cornerstone of latex allergy treatment is avoidance of the allergen itself. Several infertility drugs and drug classes contain latex (Table). Keep in mind that if a drug is stored in a vial or a syringe with a rubber stop-

per or a needle shield, inevitably latex allergens can contaminate the drug itself. These allergens pose a serious risk, with potentially serious and even fatal allergic reactions, to exposed individuals who are susceptible to latex.

If a drug is stored in a vial or a syringe with a rubber stopper or a needle shield, inevitably latex allergens can contaminate the drug itself. Therefore, becoming familiar with which drugs and drug classes contain latex is important for nurses dealing

with infertility patients. When a drug containing latex is prescribed for a patient, the nurse should ascertain that the patient is not allergic to latex, and consider whether another drug option, with similar therapeutic benefits but a different chemical profile, should be prescribed. To be certain about latex allergy, the nurse should always ask the patient about the potential for such allergy. When in doubt, contact the pharmacist, who can contact individual manufacturers, for updated information regarding the latex-free status of any infertility medications. Surprisingly, the Food and Drug Administration does not require products containing latex to be labeled as

@Copyright iStockphotos.com/drbouz

Sandra Fernandez, RPh, PharmD Pharmacist, Mandell’s Clinical Pharmacy, Somerset, NJ

such, but the pharmacist can always get that information for you. ■

Table Drugs with/without Latex Used for Infertility Treatment Drug class Follitropins Human FSH preparation Stimulate ovarian follicular growth in women who do not have primary ovarian failure

Trade product

Latexfree X

Bravelle 75IU vial Follistim AQ 75 IU vial Follistim AQ 150 IU vial Follistim AQ 300 IU cartridge

X X X

Follistim AQ 600 IU cartridge

Follistim AQ 900 IU cartridge

Gonal-f 450 IU MDV Gonal-f 1050 IU MDV Gonal-f RFF 75 IU syringe

Menotropins Preparation of gonadotropins (containing FSH and LH) extracted from the urine of postmenopausal women Stimulate ovarian follicular growth and maturation in women who do not have primary ovarian failure Chorionic Gonadotropins In women: Induce ovulation when administered after patient monitoring indicates sufficient follicular development has occurred in response to FSH treatment In men: Used to treat hypogonadotropic hypogonadism (absent/decreased function of testes)

Contains latex

X X X

Gonal-f RFF 300 IU pen Gonal-f RFF 450 IU pen Gonal-f RFF 900 IU pen

X X X

Menopur 75 IU vial Repronex 75 IU vial

X X

HCG 10,000 IU vial (APP Pharmaceuticals)a Novarel 10,000 IU vial Pregnyl 10,000 IU vial Ovidrel 250 µg syringe

X X X X

Drug class GnRH Antagonists Inhibit premature LH surge in women undergoing controlled ovarian stimulation GnRH Agonists Single daily doses result in an initial increase in LH and FSH levels, which increase estradiol levels Continuous daily administration results in decreased levels of LH and FSH, which reduces estrogen levels Lutropin Alfa Recombinant human LH (r-hLH) When used concomitantly with follitropin, stimulates the development of a potentially competent follicle and indirectly prepares the reproductive tract for implantation and pregnancy Estradiol Valerate Modulates the secretion of FSH and LH through negative feedback mechanism Used to treat hypo-estrogenism from hypogonadism or primary ovarian failure Progesterone Prepares the uterine lining to receive fertilized egg and sustains pregnancy in progesterone-deficient women undergoing ART IV Anesthetics/Antibiotics

Trade product Cetrotide 250 µg syringe Cetrotide 3 mg syringe Ganirelex 250 µg syringe

Contains latex

X X X

Leuprolide Acetate 2-wk kit 1 mg/0.2 mL (Sandoz Pharmaceuticals)b

Luveris 75 IU vial

Latexfree

Delestrogen 10 mg/mL vial Delestrogen 20 mg/mL vial

X X

Progesterone oil 50 mg/mL (Watson Pharmaceuticals)b

Manufacturer-specific: contact the dispensing pharmacy for latex information on the product being dispensed (allergic content may differ for each manufacturer)

APP Pharmaceuticals is currently the only manufacturer of this generic drug. If other manufacturers begin to produce this drug, the latex information may be different. Manufacturer’s name indicates latex information applies to that manufacturer’s brand only. Drugs manufactured by others may have different latex information. ART indicates assisted reproductive technology; FSH, follicle-stimulating hormone; GnRH, gonadotropin-releasing hormone; IV, intravenous; LH, luteinizing hormone. b

THE OB/GYN AND INFERTILITY NURSE october 2009

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Reproductive Resources

Growing Use of Newborn Umbilical Cord Blood in Regenerative Medicine David T. Harris, PhD Professor, Department of Immunobiology, University of Arizona, and Scientific Director, Cord Blood Registry

ewborn umbilical cord blood, once considered a biological waste product, has proved to be a valuable medical resource, with nearly 80 conditions now being treated with cord blood stem cells.1 Umbilical cord blood is increasingly being used in medicine, in traditional transplant applications and in regenerative medicine to heal injury and regrow tissue. Reproductive nurses are on the front line as providers of the education necessary for parents to make an informed decision on whether to donate or privately bank their child’s cord blood stem cells.

Cord Blood in Transplant Medicine Cord blood was first used as a source of hematopoietic stem cells in transplantation in 1988 for a young patient with Fanconi anemia, who received cord blood collected from his sister. More than 20 years later, the patient is disease free, and cord blood is now considered the standard of care in the pediatric transplantation setting.2 In addition to hematologic disorders, cord blood is also used for malignant, metabolic, and immune conditions. Inpatient stem-cell transplant care begins with a conditioning regimen to eradicate the underlying disease using high-dose chemotherapy and potentially radiation therapy. This regimen also serves to suppress the patient’s immune system and create space within the bone marrow to allow the stem cells to proliferate. The patient then undergoes a painless cord blood transplant via intravenous (IV) infusion to regenerate a healthy blood and immune system. After that, the patient is closely monitored for signs of infection or other complications. For conditions such as sickle-cell anemia, cord blood transplants can be completely curative. One such example is Joseph Davis, Jr., of Cedar Hill, Texas, who had a severe form of sicklecell anemia. Joseph’s father said, “Our doctors told us that unless he had a stem-cell transplant, he might not make it to his teens—and at that time he was barely 2 years old.” An unexpected pregnancy yielded joyful results: Joseph received cord blood stem cells harvested from his brother’s umbilical cord that were a genetic match. Today, his health completely restored, Joseph is a typical, rambunctious 9 years old, according to his mother. The family

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has become passionate advocates for cord blood storage, testifying in front of legislatures across the country. Regenerative Medicine More recently, advancements in regenerative medicine have led to therapies using cord blood stem cells to repair tissues once believed to be irreversibly damaged. The characteristics of cord blood that make it ideal for use in regenerative medicine include the stem cells’ ability to secrete cellular reparative factors and differentiate into many tissue types.3 Regenerative medicine research has shown great promise for brain injury, type 1 diabetes, and vascular disease, as well as exciting preclinical data for congenital heart disease.4-8 Researchers are studying the most effective treatment protocols for regenerative medicine, which will likely depend on the indication. The treatment protocol may involve a simple IV infusion, in which the stem cells will migrate to the damaged tissue (eg, brain injury, cerebral palsy, type 1 diabetes). For other indications, stem cells may be delivered directly to the damaged tissue by injection or coupled with standard therapy (eg, vascular disease). The treatment may also involve tissue-engineering techniques to generate replacement tissue grafts using

Cord Blood Registry technician handling a processing bag set after the blood components (plasma, red blood cells, and stem cells) have been separated.

autologous cord blood stem cells (eg, congenital heart disease). The Future: Educate Your Patients The use of cord blood in medicine has grown considerably. More than 15,000 cord blood transplants have been performed worldwide, and approximately 3000 patients are treated with cord blood annually.9 This number is likely to grow with expected breakthroughs in regenerative medicine research. As the use of cord blood in medicine continues to grow, so does the importance of educating expecting parents on their cord blood storage options: to donate the cord blood to a public bank for use by an unrelated patient in need, or to store with a family bank to preserve the valuable stem cells for use by

The Case of Chloe Levine Jenny Levine of Denver, Colorado, first learned about cord blood’s potential medical uses at her OB/GYN visit. She and her husband Ryan decided to privately bank their second daughter Chloe’s cord blood before her birth. Gradually, her parents realized she was not developing properly. “At 9 months, Chloe was still unable to hold a bottle and was unable to crawl properly. She had limited use of the right side of her body,” said her mother. Chloe was diagnosed with right-sided hemiplegic cerebral palsy, most likely due to an in-utero stroke. “My husband and I were completely devastated,” said Jenny. The Levines were told that Chloe faced 17 to 18 years of therapy, with no guarantees of success. But the family soon discovered a Duke University study where children with cerebral palsy were being reinfused with their own cord blood stem cells, with encouraging results. Chloe was accepted at Duke and intravenously reinfused with her cells on May 27, 2008. Shortly after, Chloe began to show changes. “Enough of the stiffness in her right foot had disappeared, and for the first time she could push the peddle down on her battery-powered tractor,” said Jenny. “She began to expand her vocabulary, saying things like her nickname, ‘Coco.’ Therapists had worked for weeks before to get her to produce words like these without success.” Today, a year and a half after infusion, Chloe no longer receives physical or speech therapy, and her occupational therapy has been cut in half. She began preschool this fall; she no longer qualifies for special needs services at school.

Technician placing cassette tray containing sealed specimens of cord blood into a dewar tank for cryogenic storage.

the newborn or by a family member. Parents and their children depend on the knowledge and expertise of those who care for them during pregnancy. An estimated 90% to 95% of cord blood is still routinely discarded after birth—an alarming statistic given the enormous potential of umbilical cord blood stem cells. The more you know, the more valuable information you can pass on about this underutilized medical resource. ■ References 1. McGuckin CP, Forraz N. Umbilical cord blood stem cells—an ethical source for regenerative medicine. Med Law. 2008;27:147-165. 2. Brunstein CG, Setubal DC, Wagner JE. Expanding the role of umbilical cord blood transplantation. Br J Haematol. 2007;137:20-35. 3. Harris DT, Badowski M, Ahmad N, Gaballa MA. The potential of cord blood stem cells for use in regenerative medicine. Expert Opin Biol Ther. 2007;7:1311-1322. 4. Cord Blood for Neonatal Hypoxic-Ischemic Encephalopathy. ClinicalTrials.gov. http://clinicaltrials. gov/ct2/show/NCT00593242?term=nct00593242&ran k=1. Accessed September 24, 2009. 5. Haller MJ, Viener HL, Wasserfall C, et al. Autologous umbilical cord blood infusion for type 1 diabetes. Exp Hematol. 2008;36:710-715. 6. Sodian R, Schaefermeier P, Abegg-Zips S, et al. Abstract 3087: human tissue-engineered heart valves based on umbilical cord blood derived progenitor cells as single cell source. Circulation. 2008;118:S812. 7. Henning RJ, Burgos JD, Vasko M, et al. Human cord blood cells and myocardial infarction: effect of dose and route of administration on infarct size. Cell Transplant. 2007;16:907-917. 8. Meier C, Middelanis J, Wasielewski B, et al. Spastic paresis after perinatal brain damage in rats is reduced by human cord blood mononuclear cells. Pediatr Res. 2006;59:244-249. 9. Frey MA, Guess C, Allison J, Kurtzberg J. Umbilical cord stem cell transplantation. Semin Oncol Nurs. 2009; 25:115-119.

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The Infertility Nurse

Third-Party Reproduction Coordinator Unique Challenges and Rewards Jill Marchetti, RN, BSN Director, Egg Donor and Gestational Carrier Program, IVF New Jersey

began my career in nursing as a pediatric intensive care nurse and enjoyed working in that field for several years. I then transferred to infertility, working as an in vitro fertilization (IVF) coordinator. Although I enjoyed that role immensely, I was drawn to third-party reproduction and eventually took a job as a donor coordinator. After a short time as a donor coordinator, I realized that my true passion was infertility, and today I cannot picture doing anything else. The role of third-party reproduction coordinator varies from clinic to clinic, but it has some basic characteristics that involve coordinating all aspects of donor, recipient, gestational carrier, and donor embryo cycles. This encompasses a host of responsibilities: • Fielding phone calls from new patients • Informational sessions with patients • Medication teaching sessions • Formulating schedules • Following recipient and gestational carrier pregnancy outcomes throughout the first trimester of pregnancy • Implementation of the Food and Drug Administration regulations for human cells, tissues, and cellular and tissue-based products. Third-party reproduction poses many challenges and rewards to clinicians. One of the main challenges is that many patients considering using donor eggs, donor embryos, or gestational car-

riers have been on the infertility roller coaster for several years. By the time they present as patients, they are emotionally and financially drained and often justifiably angered by their previous failed efforts and inability to conceive. That frustration can often cause them to be labeled “difficult,” when in fact they have just been beaten down by disappointment. Such patients are generally very well informed and have done copious research to find a clinic that will provide the best chance of success.

One of the best rewards of this specialty is that most patients get pregnant, and it is amazing to be part of a dream fulfilled. Patients often only have the financial resources for 1 more cycle. This desperation often causes enormous stress on the patient and/or the couple. Often, patients seeking third-party reproduction are also grieving the loss of their reproductive or childbearing potential. Patients frequently keep their choice to pursue alternative means to parenthood a secret from friends and family mem-

bers, which in turn fosters feelings of isolation and increased dependence on their coordinator for support. This specialized patient population requires a coordinator who is knowledgeable, understanding, and compassionate. With these challenges to face, many people may wonder why anyone would be drawn to third-party reproduction. The answer is that with all these challenges come many positive and rewarding experiences. One of the best rewards of this specialty is that most patients get pregnant, and it is amazing to be part of a dream fulfilled. Another unique and positive aspect is the close, long-term relationships that are formed between the coordinator and the patients. Many fertility cycles can take up to 6 months or more. Over that period, a special bond is formed that often continues, via e-mail updates, throughout the entire pregnancy, birth announcements, photographs, and sometimes even an in-person visit with the newest member(s) of the family. In addition, third-party reproduction coordinators work with truly diverse population of patients and medical professionals, including donors, recipients, carriers, doctors, attorneys, psychologists, embryologists, and agencies. Although the position of a thirdparty reproduction coordinator entails a complex juggling act, with many moving parts, it is also a profoundly gratify-

Definitions Third-party reproduction: Use of eggs, sperm, or embryos that have been donated by a third person (donor) to enable an infertile individual or couple (intended recipient) to become parents Donor eggs: Eggs taken from the ovaries of a fertile woman and donated to an infertile woman to be used in an assisted reproductive technology procedure Gestational carrier: A woman who carries an embryo to delivery. The embryo is derived from the egg and sperm of persons not related to the carrier. Therefore the carrier has no genetic relationship with the resulting child Embryo donation: A procedure that enables embryos either that were created by couples undergoing fertility treatment or that were created from donor sperm and donor eggs specifically for the purpose of donation to be transferred to infertile patients to achieve a pregnancy Adapted with permission from the American Society for Reproductive Medicine. Third Party Reproduction (Sperm, Egg, and Embryo Donation and Surrogacy): A Guide for Patients. 2006. www. asrm.org/patients/patientbooklets/thirdparty.pdf.

ing specialty that is on the forefront of cutting-edge technology and virtually limitless possibilities to parenthood. ■

Educate Patients on the Benefits of Single-Embryo Transfer ingle-embryo transfer can reduce the chances of multiple births after in vitro fertilization (IVF) and is cost-effective in the longterm, when considering the adverse consequences of multiple births, but patients still need to be convinced of its benefits, according to several reports presented at the 2008 annual meeting of the American Society for Reproductive Medicine (ASRM).

Single Embryos Cost-Effective, with Fewer Complications Although multiple-embryo transfers are less expensive to the patient, because it increases the pregnancy rate, single-embryo transfer is the more costeffective option in the final analysis, according to the Centers for Disease Control and Prevention (CDC). Investigators evaluated data for

159,269 fresh assisted reproductive technology (ART) cycles that progressed to transfer in 2005-2006. Of the 23,010 cycles that met the criteria in practice guidelines, only 6.4% underwent singleembryo transfer. Two embryos were transferred in >78% of the cycles, and ≥3 embryos were transferred in 15% of cycles, according to Maurizio Macaluso, MD, Head of the CDC’s Women’s Health and Fertility Branch. He suggested that insurance companies should remove the cost barriers to patients to encourage single-embryo procedures and reduce overall costs to the healthcare system. The live-birth rate per transfer for the entire cohort was 35%; the multiple-birth rate was 31%. If singleembryo transfer had been used for all cycles, the live-birth rate would have been 32% per transfer, but 97% of all

deliveries would have been singletons. Single-embryo transfer would require patients an additional $20 million to $60 million to achieve the current pregnancy rate, but the savings gained by avoiding multiple deliveries would have decreased the overall medical costs by $491 million to $1.12 billion.

Although multiple-embryo transfers are less expensive to the patient, single-embryo transfer is the more cost-effective option in the final analysis. In the CDC study, 50% of infants from multiple gestations had adverse

outcomes, and 7% were premature and had very low birth weight. Dr Macaluso recommends that insurance companies should remove barriers and provide “the right incentives” for patients to elect single-embryo procedures. The ASRM recommends singleembryo transfer for women age <35 years who have not failed a previous IVF cycle and who have additional embryos, but these are guidelines, not mandates, and are not generally followed. In a second study, single-embryo transfer in selected patients with a good-quality frozen-thawed blastocyst yielded a pregnancy rate of 31%, without multiple pregnancies. The study compared the outcomes of frozenthawed blastocyst cycles, in which 39 patients had 1 good-quality blastocyst transferred, 66 patients had a doubleembryo transfer that included 1 goodContinued on page 17

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The Infertility Nurse Educate Patients on the Benefits... quality embryo, and 140 patients had a double-embryo transfer with 2 goodquality embryos. Pregnancy rates were 35% when a double-embryo transfer contained only 1 good-quality embryo and 42% with 2 good-quality embryos; multiple-pregnancy rates were 9% and 29%, respectively. Single-Embryo Transfer Is Common in Sweden Since the introduction of singleembryo transfer, Sweden has witnessed a dramatic improvement in IVF-related outcomes, with better newborn outcomes and a reduction in workload and costs within neonatal units, according to a study that was based on the Swedish National Birth Register. From 1991 to 2005, the average num-

Continued from page 16

ber of fresh embryos transferred in Sweden was reduced from 2.7 to 1.3, the multiple-birth rate plunged from 35% to 5%, and the percentage of IVF babies with birth weight less than 2500 g dropped from 35% to <9%. DVD Use an Effective Tool Specialists have been pushing for improved education about singleembryo transfer to encourage practitioners to increase their patient education efforts. “Reducing the incidence of multiple births is an important goal,” said Mark Hornstein, MD, President of the Society for Assisted Reproductive Technology. “We need to provide more information and resources to patients, so that they too understand how sin-

gle-embryo transfer, when appropriate for an individual case, will increase the health and safety of mother and child.” This was the aim of an Australian study that showed that the use of an informational DVD is more effective than educational brochures at increasing patients’ knowledge of the risks of multiple pregnancies. The study included 100 couples starting their first IVF cycle at an Australian clinic who were randomized to use of an informational brochure or a DVD. The materials were identical, but the DVD included 2 interviews with mothers of twins, one of whom had an uneventful pregnancy and the other premature labor. The patients completed questionnaires before and after viewing the information, then again on the day of

their embryo transfer. The couples viewing the DVD were more likely to prefer single-embryo transfer and were more concerned about the risks inherent in multiple pregnancies than those receiving just the brochure. When the day of embryo transfer arrived, more patients who viewed the DVD chose single-embryo transfer compared with the brochure readers (87% vs 69%, respectively). The DVD group also reported being more “scared about having twins,” suggesting the DVD had a more emotional impact on the couple. Educational DVDs may provide an affordable and effective means of delivering health risk information, the study results suggest. ■ —Caroline Helwick

any fertility clinics today offer older women to undergo preimplantation genetic diagnosis (PGD), also referred to as preimplantation genetic screening (PGS) to identify healthy embryos without chromosomal defects, although the American Society for Reproductive Medicine (ASRM) has stated that the evidence does not yet support the use of PGD to increase pregnancy rates, and more reliable methods are needed.

Comparative Genomic Hybridization Researchers in the United Kingdom have been investigating PGS techniques using polar bodies screening, which is emerging with promising results. Comparative genomic hybrid ization (CGH), which has been studied by Reprogenetics UK and Oxford University, involves polar body screening to identify healthy embryos while sparing them excessive stress. This technique was first reported at last year’s ASRM annual meeting. Using CGH to inspect every chromosome in an embryo discarded in polar bodies, investigators detected almost twice as many maternally derived abnormalities as routine PGD screening. Elpida Fragouli, PhD, of Oxford University, explained that routine PGD screening, which is used to identify and transfer euploid embryos, permits only limited cytogenetic analysis via fluorescent in situ hybridization (FISH) blastomere examination and also poses a higher risk of injury to the embryos. In this study, CGH was evaluated in

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50 women (average age, 41 years) with multiple failed in vitro fertilization (IVF) attempts or multiple abortions. In 293 fertilized eggs, polar body DNA was subjected to whole genome amplification and CGH. Zygotes were cryopreserved while polar bodies underwent analysis. Normal embryos were thawed and transferred in subsequent cycles. Chromosome errors were detected in 43% of first polar bodies and in 40% of second polar bodies. The total oocyte abnormality rate was 65%, with most errors involving the smaller chromo-

ples with repeated implantation failure (mean of 4 cycles). First and second polar bodies were evaluated in 194 zygotes from 27 women (average age, 40 years), and analyzed by CGH. And 79 blastocysts from 13 women (average age, 37 years) were also examined. Oocyte and blastocyst aneuploidy rates were 68% and 43%, respectively, with this technique. A classification of “highly abnormal” (3 or more chromosome errors) was given to 27% of the aneuploid zygotes and 16% of the blastocysts. PGD

Using CGH to inspect every chromosome in an embryo discarded in polar bodies, investigators detected almost twice as many maternally derived abnormalities as routine PGD screening. somes. The use of FISH, which typically evaluates 9 to 12 chromosomes, would have failed to detect 48% of the abnormalities. To date, 20 of these patients have had transfers, leading to 6 pregnancies, 2 of which are ongoing, and further transfers were in progress at the time of the report. “CGH revealed that errors may affect any chromosome in human oocytes, including types of abnormalities not seen in established pregnancies,” according to Dr Fragouli. Higher Pregnancy Rate with CGH In another study from Reprogenetics UK, CGH was used to examine the entire chromosome complement of oocytes and embryos derived from cou-

screening using FISH would have failed to detect 42% of oocyte and 38% of blastocyst aneuploidies, the researchers determined. Using this method, “Thus far, 12 women have had an embryo transfer after polar body CGH, leading to 1 ongoing pregnancy. Six women have had an embryo transfer after blastocyst analysis, resulting in 4 ongoing pregnancies, with further transfers underway,” Dr Fragouli said. “Unlike oocyte screening, blastocyst analysis was associated with high pregnancy rates,” Dr Fragouli noted. The use of CGH “is likely to assist a subset of patients with repeated implantation failure (those capable of producing blastocysts) in achieving pregnancies.”

Courtesy of Dr Alfred Senn, Foundation FABER, Lausanne.

New Techniques Using Polar Bodies Screening Enhance Genetic Diagnosis

Fertilized oocyte, with 2 polar bodies (arrow). Created with OCTAX EyeWare.

European Society of Human Reproduction Embryology At the annual meeting of the European Society of Human Reproduction Embryology (ESHRE) in June 2009, Professor Joep Geraedts announced that the ESHRE Task Force would be launching a pilot study in September with a new technique to screen polar bodies, in which each pair of 23 chromosomes in polar bodies would be screened, using a new molecular DNA application and called “24sure.” The new technique was developed by BlueGnome and involves microarray technology to show that polar body screening in the later stage of embryo development works. If this first clinical trial is successful, the organization will launch an international study in 2 centers—one in Italy and the other in Germany. Professor Geraedts observed, “If we can show that polar body screening works, it will be a major step forward in improving IVF treatment for many women who have persistent difficulty in getting pregnant and maintaining pregnancy.” ■ —C.H.

october 2009 THE OB/GYN AND INFERTILITY NURSE

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Join the Academy at

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CLINIC PRO FILE

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Transitioning

EMERGING QUESTIO

How Should NS Pregnant WoWe Advise the H1N1 Flu men Regarding Vaccine? Donna Makris, RN, BSN, IBCLC Paren

to Infertility Nu rsing

Interview with Jennifer Ianna ccone, RN

• A

to The OB/GYN and Infertility Nurse, . Written for nurses by nurses, it covers current and pertinent information on the physiologic, medical, and psychological aspects of human reproduction, with special emphasis on the nurse’s role in patient care ($150 value).

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on all American Academy of OB/GYN and Infertility Nurses™ educational activities, including more than $200 off future Annual Meeting registration fees.

t Education Coord inator, Saint Peter’ s Medical Cente bstetricians, midwi r, New Brunswick, ves, and nurse NJ practitioners in New Bruns in the Unite wick, New Jersey d offer a wide States agree , we with the recen array of classes national recom t tant famili for expecmendations that es, and, as nant women should pregthe Parent have priority once Education Coordinator, a vaccine for the I am certain that many of novel H1N1 influe za virus (also know n- asking about our participants will be n as the swine becomes availa flu) fall. OB/G the H1N1 flu vaccine this ble. YN nurses and At Saint Peter’ other working with s University Hospi pregnant wome nurses tal be prepa n should red to provide information to

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for issues such as coverage and reimbursement.

Research

Interview with Sue Jasulaitis, RN, MS n her role as Clinic ue Jasulaitis is New Jersey, Jennif al Manager at IVF dure, which Clinic Manager at Fertili al Research precepted many er Iannaccone has has a lower is less intrusive but also ty Centers of nurses to the field success rate. If Illinois (FCI), infertility. In the IUI fails, of the coupl River North, this interview, Chica e then in go. tries In this interview describes the steps an IVF she dure, which she discusshas a very good proce- es key features of ic to help a new she takes at her clin- rate the cente success nurses at our center. nurse get famili can improve patien r and how ar with the demands of The nurse is t care by this field. gesting problem the areas to study basedsugnates the patien one who coordi- their on own t’s daily experience. IVF cycle. She Do you do only writes up the patient’s IVF at IVF New Jerse IVF procedures We assign y? the start dates protocol. What are some Actually we have of medicaof the special tions and once features of FCI? a lot more coupl a protocol is who are doing deterintrauterine insem es mined, schedule her FCI has 10 IVF orientation tion (IUI) than ina- and make offices aroun in d the (IVF). The reason vitro fertilization the appro sure she has undergone all Chicago area, with 2 fully staffed in is that IVF is a vitro fertilization priate testing. intrusive proce (IVF) centers. dure; it is a surgic more dinate with the husba We also coor- one of the FCI is largest al pro- semen cedure that requir nd to have his frozen es general anesth the country, and fertility centers in and involves esia day of retriev , which is used if on the has provided more ment to >100, treatal he is unable Inside River North more couples begin risk. Therefore, a specim 000 to patients during produce past . en. All with an IUI proce the mately 60 - of knowledge. this involves a new set specia25 years. We have 11 physic ians support clinical staff, as well as 120 Basic infertility lized in reprod staff employed uctive medicine, may be large at FCI. a team of embry Our main Continued on page ologists, appro 6 xi- quality care goal is to combine the best that expertise, technology,

Inside

Pharmacy Corn Latex allergies in er infertility drugs

Newborn Umb Cord Blood ilical The case of Chloe Levine

Hill Healthcare

Communicatio ns, LLC

Fertility Ce How Nurses Can nters of Illinois Influence Infertilit y

Page 14

• Obtain to the enhanced, member-only sections at www.obgyn-infertility-nurse.org to network with your peers in a community of OB/GYN, Infertility, and Urology Nursing Professionals. Discuss current and emerging diagnostic and therapeutic options, as well as strategies for counseling and follow-up of patients.

Continued on page

CLINIC SPO TLIGHT

IVF New Jersey Roychowdhury, nurses outside the clinic (from left): Jamie Thom Lauren Noble, Jennifer Iannaccone, Zofia Mance as, Leslie Meincke, ra, Cathy Ovacz Ella Terri Nelson. , Jill Marchetti,

Page 15

Continued on page

Polar Bodies Screening New techniques enhance genetic diagnosis

Page 17

Obesity and Reproduction What nurses need to know

Page 24

VOL 1, NO 1

The official pu blication of the American Academy of OB/GYN and Infertility Nu rses

TOGIN1009_ASCO Highlights Tabloid 10/5/09 5:59 PM Page 19

Clinical News Clinical News... Continued from page 3 from couples older than age 35 undergoing in vitro fertilization (IVF) are the age of both parents and the level of anti-Mullerian hormone (AMH), a hormone secreted by the testes. The team of researchers analyzed data of 336 couples undergoing IVF. Results showed that among the ovarian reserve tests, including baseline follicle-stimulating hormone levels and antral follicle count, only AMH was a significant predictor of live births. Age of the parents was the second significant predictor. The researchers note that using a pregnancy-outcome marker, such as age or AMH levels, before controlled ovarian stimulation would be helpful during patient counseling, especially for expensive treatments such as IVF. (Lee TH, et al. Reprod Biol Endocrinol. 2009;7:100.)

the journal that has asked for this study requested further experiments to better understand the implications of their initial findings.

Many Australian Infertile Women Not Seeking Help A longitudinal study of thousands of Australian women has revealed that only 33.3% of those with infertility were seeking hormonal treatment and/ or in vitro fertilization (IVF) for their

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had sought advice for their fertility concerns, but again only 50% of them had sought hormonal treatment or IVF. Women with infertility were significantly more likely to seek advice if they had polycystic ovary syndrome or endometriosis. They were less likely to seek help if they had never been pregnant, had a terminated pregnancy, were obese, or smoked daily. (Herbert DL, et al. Austr N Z J Public Health. 2009;33:358-364.) ■

Articles Wanted We invite you to submit articles for publication in The OB/GYN and Infertility Nurse. Articles should cover topics relevant to OB/GYN, infertility, and urology nurses.

Human Sperm Created from Embryonic Stem Cells In the search for new ways to help men with infertility problems, British scientists announced in July that they have succeeded in developing human sperm from human embryonic stem cells. Dr Karim Nayernia and colleagues noted that sperm produced in that way, using what is called in vitro derived sperm, cannot be used for fertility treatment, and this was not the purpose of the study. Rather, the goal of the study was to understand infertility problems in men in relation to sperm quality and other issues affecting infertility. This study was originally scheduled to be published in the July 2009 issue of Stem Cells and Development, but publication was delayed, Dr Nayernia told The OB/GYN and Infertility Nurse, because

fertility problems. The study was based on responses to 4 rounds of surveys completed by women participating in the Australian Longitudinal Study on Women’s Health (ages 28-33). A total of 14,247 women (18-23 years old) responded to the first survey. An additional 9145 responded to the fourth survey (25-30 years old). At the time of the fourth survey, 17.3% of the women reported infertility. Approximately 71% of these women

Potential Topics/Areas of Interest • • • • • • • • • • • • •

Reproductive Medicine Pregnancy Preterm Labor Ectopic Pregnancy HIV and Pregnancy Hypertension in Pregnancy Women’s Health Men’s Health Infertility in Men Female Sexual Dysfunction Erectile Dysfunction Sperm Analysis Psychology and Physiology of Aging • Medical Aspects of Sexuality/Fertility

• Psychological Aspects of Infertility • Endocrine Complications • Ovarian Hyperstimulation Syndrome • Genetic Disorders and Infertility • Genetic Screening • Alternative Medicine, Nutrition, Acupuncture • Osteoporosis and Sexuality • Cancer and Fertility Preservation • Infectious Diseases and Reproduction • Weight Issues in Fertility • Drug Therapies • Birth Control, Contraception

How to Submit Articles must be double-spaced and saved as a Word file. They must include a title, name of author, and full contact information, including telephone and e-mail address. Submit your article electronically to: lara@greenhillhc.com, Telephone: 932-992-1892.

Also wanted • Volunteer your clinic to be featured in this journal • Continuing Education articles To have your clinic featured in the journal, or to submit an article that will carry Continuing Education Credit, contact Dalia Buffery at: dalia@greenhillhc.com, Telephone: 732-992-1889.

october 2009 THE OB/GYN AND INFERTILITY NURSE

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The OB/GYN & Infertility Nurse

Polycystic Ovarian Syndrome Medical and Reproductive Implications Aaron S. Lifchez, MD, and Sue Jasulaitis, RN, MS Dr Lifchez is Clinical Associate Professor, University of Illinois, Chicago. Ms Jasulaitis is Clinical Research Manager, FCI, Chicago.

olycystic ovarian syndrome (PCOS) is a common reproductive disorder affecting about 10% of women in their childbearing years. PCOS is often accompanied by irregular menstrual cycles (oligomenorrhea), excess body hair (hirsutism), excess weight, and infertility. In addition to reproductive problems, however, women with PCOS have an increased risk for the metabolic syndrome, characterized by several cardiovascular (CV) risk factors, including insulin resistance. Therefore, recognizing the woman with PCOS is important not only for increasing her chance of getting pregnant but also for reducing her risk of heart disease or other medical complications.

Diagnosis The diagnosis of PCOS is made by first excluding other potential diagnoses and by establishing the presence of 2 of the following 3 criteria (which were last revised in 2003): 1. Absent or irregular ovulation 2. Appearance of polycystic ovaries (PCO) on ultrasound, defined as the presence of ≥12 follicles in each ovary, measuring <10 mm 3. Clinical or laboratory evidence of increased levels of androgens (male hormones). Transvaginal ultrasound is a sensitive and specific tool for detecting PCO. Assessing the levels of active or bioavailable androgens includes measuring free testosterone and calculating the free androgen index. Measuring dehydroepiandrosterone (DHEA) and DHEA with sulfate ester may also be helpful. The symptoms of PCOS often have a gradual onset. Irregular menstruation and hirsutism may appear after the first menstrual period, but most women do not seek help until their early or mid20s. Abnormal vaginal bleeding is also a common complaint. Some women may stop menstruating or have oligomenorrhea; this irregular shedding of the uterine lining (endometrium) can lead to premalignant changes, such as endometrial hyperplasia with/ without atypia, and if left untreated can result in endometrial cancer. Insulin Resistance In addition to these reproductive issues, women with PCOS are at risk of developing metabolic complications that increase the risk for CV disease, including:

Coming in December Drug Therapy for PCOS Part 2 of this article will provide details of the benefits and uses of each of the drug classes used for PCOS.

1. Elevated cholesterol and/or triglyceride levels 2. Type 2 diabetes 3. Hypertension 4. Obesity. Therefore, particularly in obese women with PCOS, it is important to do an oral glucose tolerance test and a lipid panel. By age 40, up to 40% of patients with PCOS have impaired glucose tolerance or diabetes. Treatment of PCOS is therefore not only directed at correcting reproductive problems but also at decreasing the CV risk factors, which are more of a problem for obese patients than for lean patients with PCOS. PCOS appears to be clustered in families, suggesting that the cause is likely genetic, at least in part. Because women with PCOS have a decreased insulin resistance, their bodies compensate for it by overproducing insulin. The resulting hyperinsulinemia contributes to excess production of androgens by the ovaries, leading to hirsutism and contributing to ovulatory and menstrual disorders. A suggested pathway for the development of these conditions is described in the Figure. Given the strong evidence that excess insulin plays a role in the development of PCOS, it is reasonable to assume that reducing circulating levels of insulin will help restore normal reproductive function and fertility. Incorporating lifestyle changes—in cluding improved nutrition (particularly reduced carbohydrate intake), weight loss, and an exercise regimen— in combination with the use of insulinsensitizing agents, can be critical to the successful treatment of PCOS. Dietary Recommendations Recommended dietary changes for patients with PCOS include: • Avoiding carbohydrates by themselves and instead combining them with proteins and fats • Spacing out carbohydrates during the day (as opposed to eating all carbohydrates in 1 meal), which reduces the rise in blood glucose level that causes a sharp rise in insulin. • Consuming carbohydrates with a low glycemic index (glycemic index is a measure of how fast the body

THE OB/GYN AND INFERTILITY NURSE october 2009

converts carbohydrates into glucose; the lower the glycemic index, the slower the conversion to glucose and the slower the increase in insulin) • Whenever possible, avoiding carbohydrates that tend to increase the appetite, such as pasta. Exercise Women with PCOS must exercise regularly to lower insulin levels (and help weight loss). Exercise of any type helps and is especially useful for reducing insulin after a meal. Advise patients to find an activity that is pleasant for them; those not currently exercising much should start slow and build it up toward the goal of exercising 5 days a week for 60 minutes. The more exercise, the better: • Aerobic exercise burns calories, aids in weight control, lowers blood pressure, raises high-density lipoprotein (good) cholesterol, and may decrease insulin resistance • Resistance training builds lean muscle mass and helps decrease the potential for osteoporosis • In overweight patients (body mass index ≥25 kg/m2), a reduction in serum androgens, and spontaneous

resumption of regular menstruation, may occur with as little as a 5% decrease in weight. Drug Therapy for PCOS There are many medications used for PCOS. Essentially treatment is directed at the symptoms of PCOS other than infertility (irregular menstrual periods, hirsutism), or at infertility. The various drug options include: • Oral contraceptives • Antiandrogens • Ovulation-inducing agents • Insulin-sensitizing agents. Drugs used for type 2 diabetes, known as insulin-sensitizing agents, are very effective in the treatment of PCOS. These drugs improve the body’s response to insulin, thereby reducing the need for excess insulin and restoring insulin levels to normal. At present, many reproductive endocrinologists believe that insulinsensitizing agents represent the firstline therapy for patients with PCOS interested in achieving pregnancy. These agents do need to be prescribed in conjunction with a carbohydraterestricted diet, as well as weight loss for those patients with PCOS who are obese, and increased exercise. ■

Figure Insulin Resistance, Hyperinsulinemia, Oligo-Anovulation, and PCOS Insulin resistance

Hyperinsulinemiaa

Decreased SHBG production by the liver

Increased ovarian production of androgen

Disordered release of LH/FSHb

Oligo-anovulationd

Hyperandrogenismc

PCOS a

Elevated levels of insulin in the blood. Pituitary hormones that stimulate the ovaries. Elevated blood levels of male hormones. d Absent or irregular ovulation. LH indicates luteinizing hormone; FSH, follicle-stimulating hormone; PCOS, polycystic ovarian syndrome; SHBG, sex hormone–binding globulin. b c

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The Cancer Patient

Fertility Preservation before Cancer Treatment Nurses Must Get Involved atients with cancer who wish to preserve their fertility after chemotherapy may be getting shortchanged, oncologists suggested at the 2009 meeting of the American Society of Clinical Oncology (ASCO).

when it is too late, said Gwendolyn Quinn, PhD, MPH, Moffitt Cancer Center, Tampa, Florida, at ASCO. Dr Quinn did a national survey of oncologists, showing that although many of them discuss fertility preservation with their patients, 25% never or only rarely refer patients to infertility specialists or to reproductive endocrinologists before cancer treatment. Oncologists often say that fertility preservation seems far less important than saving a life. As one oncologist said, “I’m very uncomfortable saying to a patient, ‘You have a 20% chance of survival, and by the way, have you ever thought about having kids?’” reported Dr Quinn.

freezing. Oncologists should not be having this discussion at the end of the treatment plan.” Other concerns include cost and safety of the procedure, leading many patients to opt for other reproductive options.

“We should train RNs or NPs, appoint consultants in fertility preservation within cancer centers, and develop focused fertility-preservation programs.” —Kutluk Oktay, MD

Kutluk Oktay, MD

Chemotherapy and radiotherapy often result in premature ovarian failure: 40% to 80% of women of childbearing age who have cancer become infertile after cancer therapy, and 30% to 75% of men become sterile. The risks vary by the patient’s age and treatment regimen, but age at the time of chemotherapy is the main factor. The patient risk for becoming infertile can be easily calculated on www.fer tilehope.org/tool-bar/risk-calculator.cfm. A loss of fertility is obviously an immense concern for people, but patients with cancer may only become aware of this after cancer treatment,

Timing Is Critical A key barrier to discussing fertility preservation with patients is the imperative to initiate cancer treatment immediately. But Kutluk Oktay, MD, Director of the Institute for Fertility Preservation in New York City (www.fertilitypreser vation.org), and Director of the Division of Reproductive Medicine, New York Medical College, emphasizes that fertility preservation must be considered as early as possible to preserve the full range of treatment options. “Most fertility approaches [for women] revolve around the menstrual period. If patients are not referred early enough, they may miss this opportunity,” he said at the meeting. “Our biggest ally is time. We need 2 weeks from the start of the menstrual period to stimulate egg production and perform embryo or egg

Nurses Can Make a Difference The time barrier can be reduced with the involvement of nurses, Dr Quinn suggested. “While physicians will want to present the information initially, nurses may be the more appropriate providers for having lengthy conversations and doing follow-up and referrals,” she said. Dr Oktay agreed: “We should train RNs or NPs, appoint consultants in fertility preservation within cancer centers, and develop focused fertilitypreservation programs.” A common scenario is a 30-year-old childless woman, who is diagnosed with breast cancer and is scheduled to receive dose-dense doxorubicin plus cyclophosphamide, followed by paclitaxel. It is estimated that this common

Fertility Preservation for Other Patients At last year’s meeting of the American Society of Reproductive Medicine, Dr Oktay said that fertilitypreservation procedures are expanding to patients without cancer. Of a cohort of 515 patients referred to his Institute for Fertility Preservation in the past decade, 5% had no cancer, but he said this is now the fastest growing group of patients being referred to him. Of these 515 patients, 226 (44%) did undergo fertility preservation, 217 (42%) declined it, and for 72 (14%) it was deemed inappropriate. The reasons for these 72 cases were: 33 were already menopausal, 24 had low ovarian reserve, and 15 had chronic diseases at advanced stages. The institute now has more than 300 patients annually compared with only a few patients annually 10 years ago. chemotherapy regimen will result in the loss of 10 years’ worth of oocytes, giving this 30-year-old woman an egg reserve of a 40-year-old woman. After chemotherapy, the patient is prescribed tamoxifen for 5 years, during which time she must forego pregnancy; this reduces her already diminished egg reserve to that of a 45-year-old. As a result of her cancer treatment and the lack of fertility preservation, this woman has a near-zero probability of achieving a pregnancy and bearing even one child. ■ —Caroline Helwick

Drugs that Increase BMD Important for Bone Health in Breast Cancer one health is increasingly recognized as an important factor in women with breast cancer, with adverse effects possible from both cancer and its treatment. At the recent meeting of the American Society of Clinical Oncology, Larry J. Suva, PhD, of the University of Arkansas for Medical Sciences, Little Rock, noted that 2 major bonerelated processes are of concern in early-stage breast cancer: postmenopausal- and treatment-induced osteoporosis, and the development of bone metastases in any patient with breast cancer. Patients with breast cancer often have osteoporosis. Osteoporosis occurs

Oral bisphosphonates, which are indicated for the prevention/treatment of osteoporosis, can substantially increase BMD in patients with bone loss associated with aromatase inhibitors in postmenopausal women. when bone remodeling favors the resorption process mediated by osteo-

clasts, which are stimulated by the receptor activator of the nuclear factor kappa-beta ligand (RANKL). During bone resorption, activated osteoclasts produce molecules and enzymes that can degrade the bone matrix. Agents that inhibit osteoclast activity, therefore, can promote bone health, according to Dr Suva. In patients with breast cancer who have osteoporosis, recent data are showing that bisphosphonates, as well as denosumab, which is currently under FDA review, can increase bone mineral density (BMD). Bisphosphonates inhibit an important enzyme in osteoclasts while denosumab inhibits RANKL, he explained. Continued on page 23

THE OB/GYN AND INFERTILITY NURSE october 2009

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The Cancer Patient Drugs that Increase BMD... Continued from page 22 Osteoclastic activity may also be important in the metastatic process. Interleukin-8 (IL-8) is an inflammatory marker common in postmenopausal women with osteoporosis and in women with breast cancer. IL-8 is implicated in bone resorption, and high levels of IL-8 have been correlated with decreased survival in patients with metastatic breast cancer. Agents that inhibit osteoclast activity are now recognized for their protective role in breast cancer, Dr Suva noted. A recent pivotal study (N Engl J Med. 2009;360:679-691) showed that the addition of the bisphosphonate zoledronic acid to adjuvant endocrine therapy in patients with early-stage breast cancer reduced the risk of disease progression by 36%. “Patients with early-stage disease can have better clinical outcomes if treatment regimens also incorporate agents that inhibit osteoclast activity,” said Michael Gnant, MD, Medical University of Vienna, Austria, during this bone biology session at ASCO. Bone loss associated with aromatase inhibitors is a rising concern, said Catherine H. Van Poznak, MD, of the University of Michigan, Ann Arbor. In managing breast cancer, clinicians should address such comorbid factors and concerns as osteoporosis, and should balance the risk:benefit ratio of specific treatment options. Oral bisphosphonates, which are indicated for the prevention/treatment of osteoporosis, can substantially increase BMD in patients with bone loss associated with aromatase inhibitors in postmenopausal women, said Dr Van

Poznak, and potentially also in premenopausal patients, and in women with breast cancer and chemotherapyinduced ovarian failure, she said. Henry G. Bone, MD, of the Michigan Bone and Mineral Clinic, stressed the importance of calcium and vitamin D in patients with breast cancer, and empha-

sized the value of oral bisphosphonates as a means of preventing bone loss associated with aromatase inhibitors. “Strictly from the standpoint of preventing or treating osteoporosis, conventional dosages of bisphosphonates should be adequate in women receiving adjuvant therapy,” Dr Bone said, but he

noted that studies evaluating bisphosphonates in conjunction with aromatase inhibitors used much higher doses than those used in postmenopausal women with osteoporosis. The “limiting dose” of these agents in the breast cancer setting is not yet clear. ■ —Caroline Helwick

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• Ovarian Hyperstimulation Syndrome • Acupuncture and Stress • IVF Failure in Good Responders • Development in Egg Freezing • Drug Therapy for PCOS

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Obesity & Reproduction

Effects of Overweight/Obesity on Fertility What Nurses Need to Know Pat Cullen, RN Director of Operations, Fertility Centers of Illinois

patient presented to the clinic with the following complaints: I have been struggling with my weight for many years. As a college student, I used to work out, but since then I have progressively gained weight, and now it is so hard to lose any of these additional pounds. Do you think it is making it harder for me to get pregnant? I have been married since 2003, and have been trying for pregnancy since 2005. Being overweight is common today; about 61% of American women are overweight, 33% are obese, and 6.9% are morbidly obese. Much of the medical literature discusses obesity in relation to body mass index (BMI), the measure used to define weight. The Centers for Disease Control and Prevention classifies BMI as1: • Normal: >18.5 kg/m2-24.9 kg/m2 • Overweight: 25 kg/m2-29.9 kg/m2 • Obese: ≥30 kg/m2 • Morbidly obese: ≥35 kg/m2 The deleterious effects of obesity on reproductive health include menstrual disorders, infertility, and maternal complications during pregnancy.2-4

BMI and IVF Success Studies involving the link between body weight and in vitro fertilization (IVF) have yielded inconsistent results, some showing reduced pregnancy and live birth rates in overweight/obese women compared with normal-weight women,5-10 and some showing no such differences.11-16 But women with elevated BMI may require more effort to achieve pregnancy, and once in fertility treatment, they may require increased doses of fertility stimulation medicine.5,12 Obese patients also require an alternation in their treatment regimens, because of an overall lower medicine response, as measured by longer cycle stimulation days, less eggs produced, more cancel led cycles, and lower pregnancy rates.5,11-13,16 This may be related to the effects of obesity on hormone production, which can cause a lack of ovulation and irregular menstrual cycles. We conducted a recent study (to be presented at the 2009 annual meeting of the American Society of Reproductive Medicine) at the Fertility Centers

of Illinois on BMI and pregnancy, which shows that BMI affects the success of fertility treatment with IVF.17 Results show that the higher a woman’s BMI is, the harder it is for her to become pregnant. However, a woman nearing age 40 is affected more by her age than by her weight in her ability to get pregnant. That is, high BMI has a profound negative effect on IVF pregnancy rates, but that effect diminishes with age.17 From a nursing perspective, patients with a high BMI often need increased emotional support in their attempt to reduce weight and while being in treatment. Advise these patients during treatment that they may face an in creased risk of cycle cancellation, lower eggs production, a higher amount of immature or abnormal eggs, a lower or failed fertilization rate, decreased pregnancy rate, and a higher miscarriage rate. Also advise them that they will be prescribed additional medications to attempt to counteract these issues and manage the underlying medical problems associated with obesity. BMI and Pregnancy Pregnancy-related complications increase dramatically in patients with a high BMI, including17: • Increased risk for miscarriage • Gestational diabetes • Preeclampsia. In addition, overweight pregnant women are at increased risks for infection, Cesarean delivery, stillbirth, and anesthesia-related complications. Advise your obese patients that IVF treatment is considered elective medical therapy, because it is potentially associated with additional medical risks, which are amplified in obese women and in other at-risk populations. For these reasons, IVF cycles have been delayed or cancelled to decrease the risk to the patient. Nurses should routinely counsel obese patients that medical clearance will be required if they are pursuing treatment Recommendations The obese patient should begin by losing weight. The obese, younger woman who has been unsuccessful in her attempts to achieve pregnancy after 6 to 12 months should seek a consultation with a reproductive endocrinologist or an OB/GYN. However, an older obese woman should not put off the more aggressive fertility treatment while trying to lose weight, because eggs are rapidly aging.

THE OB/GYN AND INFERTILITY NURSE october 2009

Diet modification and aerobic exercise are very important. Even modest weight modification results in an increase in pregnancy rates. Some patients choose surgical assistance to weight loss; gastric bypass surgery involves new metabolic needs and changes. After bypass surgery, delaying pregnancy for at least 1 year is recommended. Other weight-loss options include nutritional counseling and holistic approaches to health. At our clinics, we work closely with centers that offer yoga for fertility and nutrition experts specializing in fertility and weight loss.

The higher a woman’s BMI is, the harder it is for her to become pregnant. However, a woman nearing age 40 is affected more by her age than by her weight in her ability to get pregnant. Environment, exercise, and lifestyle changes are keys to success. Weight loss may make it more likely that the woman will achieve pregnancy and have a safe pregnancy and delivery. This will also reduce the risk of diabetes and heart problems later in life. Appropriate nursing support and counseling is critical to help these patients have a positive experience while maximizing their ability to fulfill their dreams of pregnancy. ■

References 1. Ogden CL, Carroll MD, Curtin LR, et al. Prevalence of overweight and obesity in the United States, 19942004. JAMA. 2006;295:1549-1555. 2. Sharpe RM, Franks S. Environment, lifestyle and infertility—an inter-generational issue. Nat Cell Biol. 2002;4(suppl):S33-S40. 3. American College of Obstetricians and Gynecologists. ACOG Committee Opinion, September 2005. Obesity in pregnancy. Obstet Gynecol. 2005;106:671-675. 4. Pasquali R, Pelusi C, Genghini S, et al. Obesity and reproductive disorders in women. Hum Reprod Update. 2003;9:359-372. 5. Fedorcsák P, Dale PO, Storeng R, et al. Impact of overweight and underweight on assisted reproduction treatment. Hum Reprod. 2004;19:2523-2528. 6. Wang JX, Davies M, Norman RJ. Body mass and probability of pregnancy during assisted reproduction treatment: retrospective study. BMJ. 2000;321:1320-1321. 7. Loveland JB, McClamrock HD, Malinow AM, Sharara FI. Increased body mass index has a deleterious effect on in vitro fertilization outcome. J Assist Reprod Genet. 2001;18:382-386. 8. Nichols JE, Crane MM, Higdon HL, et al. Extremes of body mass index reduce in vitro fertilization pregnancy rates. Fertil Steril. 2003;79:645-647. 9. Lintsen AM, Pasker-de Jong PC, de Boer EJ, et al. Effects of subfertility cause, smoking and body weight on the success rate of IVF. Hum Reprod. 2005;20:1867-1875. 10. Ferlitsch K, Sator MO, Gruber DM, et al. Body mass index, follicle-stimulating hormone and their predictive value in in vitro fertilization. J Assist Reprod Genet. 2004;21:431-436. 11. Spandorfer SD, Kump L, Goldschlag D, et al. Obesity and in vitro fertilization: negative influences on outcome. J Reprod Med. 2004;49:973-977. 12. Wittemer C, Ohl J, Bailly M, et al. Does body mass index of infertile women have an impact on IVF procedure and outcome? J Assist Reprod Genet. 2000;17:547-552. 13. van Swieten EC, van der Leeuw-Harmsen L, Badings EA, van der Linden PJ. Obesity and Clomiphene Challenge Test as predictors of outcome of in vitro fertilization and intracytoplasmic sperm injection. Gynecol Obstet Invest. 2005;59:220-224. 14. Lashen H, Ledger W, Bernal AL, Barlow D. Extremes of body mass index do not adversely affect the outcome of superovulation and in-vitro fertilization. Hum Reprod. 1999;14:712-715. 15. Frattarelli JL, Kodama CL. Impact of body mass index on in vitro fertilization outcomes. J Assist Reprod Genet. 2004;21:211-215. 16. Dokras A, Baredziak L, Blaine J, et al. Obstetric outcomes after in vitro fertilization in obese and morbidly obese women. Obstet Gynecol. 2006;108:61-69. 17. Sneed ML, Uhler ML, Grotjan HE, et al. Body mass index: impact on IVF success appears age-related. Hum Reprod. 2008;23:1835-1839. 18. Wang JX, Davies M, Norman RJ. Obesity increases the risk of spontaneous abortion during infertility treatment. Obes Res. 2002;10:551-554.

Bariatric Surgery May Have Reproductive Impact orbidly obese women who undergo bariatric surgery may not only lose pounds but also increase their reproductive capacity, according to findings of 2 recent studies reported at the 2008 annual meeting of the American Society for

Reproductive Medicine. Beth M. Lewkowski, MD, and colleagues at Washington University in St. Louis followed 5 patients who had bariatric surgery before in vitro fertilization (IVF) treatments. These patients’ body mass index (BMI) before surgery Continued on page 25

Table Reduced FSH and Inhibin B in Morbidly Obese Women Measure FSH

Control group (normal weight) 4.9 mIU/mL

Obese women pre-op 3.6 mIU/mL

Obese women post-op 6.1 mIU/mL

Inhibin B

80.4 pg/mL

23.2 pg/mL

30.2 pg/mL

MIS

1.4 ng/mL

1.0 ng/mL

2.2 ng/mL

BMI

22.7 kg/m

49.1 kg/m

37.2 kg/m2

BMI, indicates body mass index; FSH, follicle-stimulating hormone; MIS, Müllerian-inhibiting substance.

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Obesity & Reproduction Bariatric Surgery... Continued from page 24 ranged from 22.8 kg/m2 to 39.2 kg/m2; their infertility duration ranged from 24 months to 10 years. Four of them underwent gastric bypass surgery and 1 had gastric banding.

Pre-op and post-op results showed low early FSH levels in the obese women; these levels were significantly recovered after a 25% weight loss post-op. All 5 women had ovarian stimulation with a standard step-down gonadotropin protocol after mid-luteal down-regulation with a gonadotropinreleasing hormone agonist: 3 of them conceived with the first IVF cycle and 2 required additional cycles to conceive. At the time of the report, 3 women successfully delivered full-term babies, and 2 were pregnant. In the second study, Alex J. Polotsky, MD, and colleagues from Albert Einstein College of Medicine measured several markers of fertility-related ovarian reserve in 20 morbidly obese women—mean BMI, 49 kg/m2—before

and after bariatric surgery. The women’s serum was measured in the early follicular phase of screening (pre-op) and 6 months post-operatively (post-op) to examine levels of folliclestimulating hormone (FSH), inhibin B, and Müllerian-inhibiting substance

(MIS). Some 36 normal-weight infertility patients served as controls. Pre-op and post-op results showed low early FSH levels in the obese women; these levels were significantly recovered after a 25% weight loss postop (Table). Inhibin B was also marked-

ly reduced in the obese women, but was slower to recover. MIS was not significantly different between obese and normal-weight infertile women; the increase in the obese patients after surgery was not significant. ■ —Caroline Helwick

Presents The Second Annual 2009 Curriculum for

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At the completion of this activity participants should be able to: • Explain how various agents and combination regimens used in induction regimens for multiple myeloma (MM) may affect stem cell mobilization • Describe the safety and efficacy of standard agents used for stem cell mobilization in patients with MM • Interpret data from clinical trials evaluating novel approaches to stem cell mobilization as reported at the 2008 ASH meeting

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Global Education Group designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

This activity was developed for physicians, nurses, and pharmacists. VOL 1, NO

Jersty ey g New IVFtion rtili Nursin ing to Infe

Physician Credit Designation

The purpose of this activity is to enhance knowledge concerning the treatment of patients with multiple myeloma (MM).

Target Audience

E.COM TY-NURS N-INFERTILI WWW.OBGY

PROFILE CLINIC

Statement of Need

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Global Education Group (Global) and Medical Learning Institute, Inc. (MLI). Global is accredited by the ACCME to provide continuing medical education for physicians.

Registered Nurse Designation Medical Learning Institute, Inc. Provider approved by the California Board of Registered Nursing, Provider 15106, for 1.0 contact hour.

Registered Pharmacy Designation MLI is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 1.0 contact hour (0.1 CEU) of continuing education credit. The universal program number for this activity is 468-999-09-027-H01-P.

Agenda: 1 hour Articles/Commentaries: 45 minutes Evaluation/Posttest: 15 minutes Date of original release: August 31, 2009 Valid for CME credit through: August 31, 2010

This activity is jointly sponsored by

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genetic diagn Page 17

n Reproductio Obesity and s need to know What nurse Page 24

This activity is supported by an educational grant from Millennium Pharmaceuticals, Inc.

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october 2009 THE OB/GYN AND INFERTILITY NURSE

TOGIN1009_ASCO Highlights Tabloid 10/5/09 5:59 PM Page 26

ASRM Meeting Highlights

Multidisciplinary Approach to Patients with HIV Provides Reproductive Services t the 2008 annual meeting of the American Society for Reproductive Medicine (ASRM), Nataki Douglas, MD, of Columbia University, discussed a relatively new multidisciplinary approach to patients with HIV who are considering starting a family or becoming pregnant. The reproductive needs of HIV-seropositive women can be successfully managed by using such an approach, Dr Douglas said. “Nearly 130,000 American women are HIV positive. Most are at reproductive age and many desire children,” Dr Douglas said. Since its inception in 1997, the program has performed around 500 cycles of in vitro fertilization (IVF) or intrauterine insemination (IUI) for couples whose family planning is complicated by HIV. She believes this is the first program of this nature in the United States.

All patients seen in this program have a multidisciplinary evaluation before fertility treatment. This includes medical evaluations with an infectious diseases specialist and an obstetrician specialized in dealing with high-risk patients, as well as a psychosocial assessment and consultation with a maternal fetal medicine specialist with a special interest in HIV. Family and support structure are determined. All oocyte retrievals are performed in a separate operating room designed to handle virally infected patients. Oocytes are stripped of granulosa cells to remove elements containing blood inside a portable incubator before gamete transfer into the embryology laboratory for fertilization via intracytoplasmic sperm injection. Separate Forma CO2 incubators are used for oocytes and embryos from HIV-positive patients, as required by the US Food

and Drug Administration. A retrospective analysis included 40 HIV-positive women seen at the program between 2000 and 2007; the average patient was 37 years old and was diagnosed with HIV approximately 7 years earlier. All were receiving antiretroviral therapy.

“Nearly 130,000 American women are HIV positive. Most are at reproductive age and many desire children.” —Nataki Douglas, MD Of these 40 women, 25 underwent controlled ovarian hyperstimulation and IUI (n = 8) or IVF (n = 17), and 11 delivered babies. Of the patients in the IVF group, 3 had miscarriages.

All children were HIV negative at birth and remained so at 3 and 6 months after delivery. In each case, the mother’s CD4 cell counts remained stable throughout the pregnancy and the viral loads remained undetectable. Marc Sauer, MD, who heads the Columbia program, said, “It’s a fairly rare center in this country that offers this care to people with HIV.” He added that he sees people all over the country who do not get fertility care because of their HIV status. David Adamson, MD, past president of ASRM, commented that the Co lumbia program “is a good example of what can be achieved when reproductive specialists partner with their colleagues in maternal-fetal medicine and infectious disease….HIV-positive men and women live full lives, which can include the joys of parenthood.” ■ —Caroline Helwick

Common Household Contaminant May Affect Fertility Preliminary Studies Suggest a Harmful Association common chemical component of plastics, bisphenol A (BPA), found in plastic food and beverage containers, could reduce fertility in men and women, according to preliminary studies presented at ASRM 2008. BPA affects cells and tissues in much the same way as estrogen. The Centers for Disease Control and Prevention has estimated that BPA is present to some degree in the urine of most of the US population. BPA is found in hard plastics, bottles, cans, baby formula, eyeglasses, and dental sealants, among other things.

BPA’s Effects on Semen In a prospective cohort of 71 male partners of women seeking fertility treatment, Harvard investigators found that 90% of the men had urinary evidence of BPA exposure at a mean concentration of 2.4 mg/L. The results showed an association, which did not reach statistical significance, between elevated levels of BPA and poor semen quality, reported Shelley Ehrlich, MD, of Harvard School of Public Health, Boston. The men with BPA concentrations above the mean of the study group had 3.5 times greater chance of having low sperm concentrations compared with men whose exposure fell below the mean. Although the results did not reach significance, they confirm findings from animal studies and are also in line with at least one other human study, Dr Ehrlich said.

Nevertheless, “this is a very small study with preliminary findings, so we should interpret the results with caution,” Dr Ehrlich cautioned. She and her colleagues plan to study the association between BPA concentrations and various semen parameters.

“As levels of contaminants increase in the environment, they increase in our bodies. Estrogenmimicking chemicals like BPA have potential to cause damage.” —David Adamson, MD BPA’s Effects on Female Reproduction In another study reported at the meeting, Julie Lamb, MD, of the University of California, San Francisco, and colleagues found that BPA appears to have similarly harmful effects on female reproduction. She and her colleagues conducted a pilot study to explore the correlation between BPA levels and reproductive outcomes in 44 women undergoing their first cycle of in vitro fertilization (IVF). Quantifiable blood levels of BPA were detected in 93% of the women, at a mean concentration level of 4.2 ng/mL, although levels ranged as high as 67.4 ng/mL.

THE OB/GYN AND INFERTILITY NURSE october 2009

Of the 44 women, 22 became pregnant, and they tended to have lower BPA concentration levels (mean, 3.4 ng/mL) than the other women undergoing IVF who did not become pregnant (mean 4.2 ng/mL), Dr Lamb reported. BPA may be exerting effects that are related to estrogen metabolism, suggested Lusine Aghajanova, MD, PhD, also from the University of California, San Francisco. In an in vitro study, she exposed human endometrial stromal fibroblasts (hESF) from hysterectomy specimens to normal environmental concentrations of BPA, and found that the chemical had variable effects on genes involved in estrogen metabolism and on the differentiation of hESF cells. Specifically, the cells displayed disrupted proliferation and maturation.

“If the endometrium does not develop normally, it may not coordinate with embryo development and implantation will not occur,” Dr Aghajanova explained. “People need to try and reduce their exposure to BPA.” Reducing exposure is not easy to do, however, because BPA is found in so many common products. Commenting on the studies, David Adamson, MD, past president of ASRM, pointed out, “As levels of contaminants increase in the environment, they increase in our bodies. Estrogenmimicking chemicals like BPA have potential to cause damage. These studies are the beginning, but more research is needed to fully define the effects of BPA and to understand its mechanisms.” ■ —C.H.

“Care to do a little proliferating?”

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CRINONE® 4% CRINONE® 8% (progesterone gel) See package insert for full prescribing information. INDICATIONS AND USAGE Assisted Reproductive Technology Crinone 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency. Secondary Amenorrhea Crinone 4% is indicated for the treatment of secondary amenorrhea. Crinone 8% is indicated for use in women who have failed to respond to treatment with Crinone 4%. CONTRAINDICATIONS Crinone should not be used in individuals with any of the following conditions: known sensitivity to Crinone, progesterone or any of the other ingredients; undiagnosed vaginal bleeding; liver dysfunction or disease; known or suspected malignancy of the breast or genital organs; missed abortion; active thrombophlebitis or thromboembolic disorders; or a history of hormoneassociated thrombophlebitis or thromboembolic disorders. WARNINGS The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose. PRECAUTIONS General 1. The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear. 2. In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, nonfunctional causes should be considered. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken. 3. Because progestogens may cause some degree of fluid retention, conditions which might be influenced by this factor (e.g., epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. 4. The pathologist should be advised of progesterone therapy when relevant specimens are submitted. 5. Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. 6. A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progestin therapy. Information for Patients The product should not be used concurrently with other local intravaginal therapy. If other local intravaginal therapy is to be used concurrently, there should be at least a 6-hour period before or after Crinone administration. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage. Drug Interactions No drug interactions have been assessed with Crinone. Carcinogenesis, Mutagenesis, Impairment of Fertility Nonclinical toxicity studies to determine the potential of Crinone to cause carcinogenicity or mutagenicity have not been performed. The effect of Crinone on fertility has not been evaluated in animals. Pregnancy Crinone 8% has been used to support embryo implantation and maintain pregnancies through its use as part of ART treatment regimens in two clinical studies (studies COL1620-007US and COL1620-F01). In the first study (COL1620-007US), 54 Crinone-treated women had donor oocyte transfer procedures, and clinical pregnancies occurred in 26 women (48%). The outcomes of these 26 pregnancies were as follows: one woman had an elective termination of pregnancy at 19 weeks due to congenital malformations (omphalocele) associated with a chromosomal abnormality; one woman pregnant with triplets had an elective termination of her pregnancy; seven women had spontaneous abortions; and 17 women delivered 25 apparently normal newborns. In the second study (COL1620-F01), Crinone 8% was used in the luteal phase support of women undergoing in vitro fertilization (“IVF”) procedures. In this multi-center, open-label study, 139 women received Crinone 8% once daily beginning within 24 hours of embryo transfer and continuing through Day 30 post-transfer. Clinical pregnancies assessed at Day 90 post-transfer were seen in 36 (26%) of women. Thirty-two women (23%) delivered newborns and four women (3%) had spontaneous abortions. Of the 47 newborns delivered, one had a teratoma associated with a cleft palate; one had respiratory distress syndrome; 44 were apparently normal and one was lost to follow-up. Geriatric Use The safety and effectiveness in geriatric patients (over age 65) have not been established. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Nursing Mothers Detectable amounts of progestins have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not been determined. ADVERSE REACTIONS Assisted Reproductive Technology In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Crinone 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women were: bloating (7%), cramps not otherwise specified (15%), pain (8%), dizziness (5%), headache (13%), nausea (7%), breast pain (13%), moniliasis genital (5%), vaginal discharge (7%), pruritus genital (5%).

Columbia Laboratories, Inc. Livingston, NJ 07039

TOGIN1009_ASCO Highlights Tabloid 10/6/09 11:46 AM Page 28

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