Ajog jm 2017

Volume 1, Number 1, January-March 2017

ISSN 0971-8788 Case Report

Asian Journal of

Obstetrics &

Gynaecology Practice In this Issue Anovulation and Infertility: Focus on Clomiphene Citrate and N-acetylcysteine for Ovulation Induction Knowledge and Attitude of Infertile Couples Attending IRM: A Prospective Observational Study Hypertensive Disorders in Pregnancy: An Obstetric Catastrophe Bilateral Single System Ectopic Ureters with Secondary Calculi in an Adult: Case Report A Rare Case of Torsion Ovarian Fibroma Case of Mix-up or Switching of Gametes, Embryos – Glaring Omission Under ART Bill, India

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

1

Asian Journal of

Online Submission

Volume 1, Number 1, January-March 2017

Contents

An IJCP Group Publication Corporate Panel Dr Sanjiv Chopra Prof. of Medicine and Faculty Dean Harvard Medical School Group Consultant Editor Dr Deepak Chopra Chief Editorial Advisor Dr KK Aggarwal Group Editor-in-Chief IJCP Group, eMedinewS and eMediNexus

FROM THE ISSUE EDITOR

Effect of Maternal Hematocrit on Offspring IQ at 4 and 7 Years of Age

5

Alka Kriplani

Dr Veena Aggarwal MD, Group Executive Editor AJOG Specialty Panel Dr Alka Kriplani Editor Consultant Editor Dr Urmil Sharma Assistant Editors Dr Nutan Agarwal (Delhi) Dr Neera Aggarwal (Delhi) Dr A Biswas (Singapore) Dr CS Dawn (Kolkata) Dr Gauri (Delhi) Dr Suneeta Mittal (Delhi) Dr S Mehra (Delhi) Dr Prashant Mangeshikar (Mumbai) Dr Prakash Trivedi (Mumbai) Dr Gita Ganguly

Mukherjee (Kolkata) Dr (Mrs) Prabha Arora (Delhi) Dr Hema Divakar (Bangalore) Dr Kamini A Rao (Bangalore) Dr Deepti Goswami (Delhi) Dr Neerja Bhatla (Delhi) Dr Bhawna Malhotra (Delhi) Dr Biswas Nicholas (Australia) Dr Sudhaa Sharma (Jammu) Dr Jaibhagwan Sharma (Delhi) Dr Veena Mathur (Agra) Dr Garima Kachhawa

Editorial Board

Obstetrics and Gynaecology Dr Alka Kriplani Dr Thankam Verma Dr Kamala Selvaraj

Cardiology Dr Praveen Chandra Dr SK Parashar Paediatrics Dr Swati Y Bhave Diabetology Dr CR Anand Moses Dr Sidhartha Das Dr A Ramachandran Dr Samith A Shetty Dr Vijay Viswanathan Dr V Mohan Dr V Seshiah Dr Vijayakumar ENT Dr Jasveer Singh Dr Chanchal Pal

Dentistry Dr KMK Masthan Dr Rajesh Chandna

FROM THE DESK OF the GROUP EDITOR-IN-CHIEF

Inform your Patients Before Traveling

6

KK Aggarwal

review article

Anovulation and Infertility: Focus on Clomiphene Citrate and N-acetylcysteine for Ovulation Induction 7 Anita Kant

Gastroenterology Dr Ajay Kumar Dr Rajiv Khosla Dr JS Rajkumar Dermatology Dr Hasmukh J Shroff Dr Pasricha Dr Koushik Lahiri Dr Jayakar Thomas Nephrology Dr Georgi Abraham Neurology Dr V Nagarajan Dr Vineet Suri Dr AV Srinivasan

Clinical Study

Knowledge and Attitude of Infertile Couples Attending IRM: A Prospective Observational Study 13 Akshaya Kumar Mahapatro, Indumathi Joy, Kundavi Shankar, Thankam Varma

Oncology Dr V Shanta Orthopedics Dr J Maheshwari

Anand Gopal Bhatnagar Editorial Anchor Advisory Body Heart Care Foundation of India Non-Resident Indians Chamber of Commerce and Industry World Fellowship of Religions

Hypertensive Disorders in Pregnancy: An Obstetric Catastrophe 20 Surya Malik, Khushpreet Kaur, Parneet Kaur

Asian Journal of Volume 1, Number 1, January-March 2017

Contents

Published, Printed and Edited by Dr KK Aggarwal, on behalf of IJCP Publications Ltd. and Published at E-219, Greater Kailash, Part-1 New Delhi-110 048 E-mail: editorial@ijcp.com

Case Report

Bilateral Single System Ectopic Ureters with Secondary Calculi in an Adult: Case Report

Printed at Edge Printers, Delhi

24

Gopi Kishore M, Suhasini G, Prasad PVGS, Sainadh AV

Copyright 2017 IJCP Publications ltd.

All rights reserved.

The copyright for all the editorial material contained in journal, in the form of layout, content including images and design, is held by IJCP Publications Ltd. No part of this publication may be published in any form whatsoever without the prior written permission of the publisher.

A Rare Case of Torsion Ovarian Fibroma

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Pradeep Musale Ramamchandra, Lalitha Shivanna, Mamatha Siddappaji

Editorial Policies The purpose of IJCP Academy of CME is to serve the medical profession and provide print continuing medical education as a part of their social commitment. The information and opinions presented in IJCP group publications reflect the views of the authors, not those of the journal, unless so stated. Advertising is accepted only if judged to be in harmony with the purpose of the journal; however, IJCP group reserves the right to reject any advertising at its sole discretion. Neither acceptance nor rejection constitutes an endorsement by IJCP group of a particular policy, product or procedure. We believe that readers need to be aware of any affiliation or financial relationship (employment, consultancies, stock ownership, honoraria, etc.) between an author and any organization or entity that has a direct financial interest in the subject matter or materials the author is writing about. We inform the reader of any pertinent relationships disclosed. A disclosure statement, where appropriate, is published at the end of the relevant article.

Note: Asian Journal of Obs and Gynae Practice does not guarantee, directly or indirectly, the quality or efficacy of any product or service described in the advertisements or other material which is commercial in nature in this issue.

MEDICOLEGAL

Case of Mix-up or Switching of Gametes, Embryos – Glaring Omission Under ART Bill, India 30 Sonali Kusum

Around THE GLOBE

News and Views

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IJCP’s Editorial and Business Offices Delhi

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FROM THE ISSUE EDITOR

Effect of Maternal Hematocrit on Offspring IQ at 4 and 7 Years of Age

Dr Alka Kriplani

Professor and Head of Unit II Dept. of Obstetrics and Gynecology AIIMS, New Delhi

M

aternal hematocrit is associated with offspring IQ at 4 and 7 years of age, suggests a new study published online in BJOG. The mean IQ at 4 and 7 years was significantly lower in the moderate and mild anemia groups than in the normal hematocrit group (92.3 and 94.7 vs.

100.6, respectively at 4 years; and 90.2 and 93.4 vs. 99.1 at 7 years). The high hematocrit group had

a significantly higher mean IQ (104.5 at 4 years; 103.2 at 7 years) when compared with the normal hematocrit group. Women with moderate anemia were more likely to have children with IQ of 70-84 at 4 years (RR 1.22, 95% CI 1.08-1.38) and <70 at 7 years (RR 1.59, 95% CI 1.14-2.23). Women with a high hematocrit were more likely to have children with an IQ ≥120 at 7 years (RR 1.22, 95% CI 1.08-1.39).

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Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

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FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

Inform your Patients Before Traveling

Dr KK Aggarwal

Group Editor-in-Chief IJCP Group, eMedinewS and eMediNexus

T

he doctor-patient relationship is a sacred relationship. This relationship is initiated when the patient comes to the doctor, who in turn agrees to treat him. This ‘implied contract’ imposes on the doctor a legal duty to exercise due skill and care in providing medical treatment. Once a doctor takes on the care of the patient, he also has a duty to provide continuity of care when he is traveling or is unable to attend to the patient.

The ‘fiduciary’ nature of the relationship, one that is based on trust, which the patient reposes in his doctor also places an ethical obligation on the doctor to always put the interests of the patient first. Patients rely on doctors for help in their time of need. Regulation 1.2.1 of MCI Code of Ethics requires that “…Physicians should merit the confidence of patients entrusted to their care, rendering to each a full measure of service and devotion.”

going to be away on a vacation or for a conference etc. also convey the same to your patient. Inform them about the duration of time you would be away and the dates of your departure and return. If you have arranged for another physician to take care of your patients in your absence, then share the names, along with his or her credentials and training, with your patients also. This enables the patient to make an informed decision, whether to continue with you as his doctor. Before doing a surgery, the patient must know that you would not be there for his post-op care.

Take an informed consent of the patient, otherwise avoid doing the surgery.

So, before you undertake a case, if you are planning a visit out of town or a vacation, you still need to take care of your patients.

A physician is required to be “diligent in caring for the sick” (MCI Regulation 1.1.2). Once having undertaken a case, the physician should not neglect the patient, nor should he withdraw from the case without giving adequate notice to the patient and his family (MCI Regulation 2.4).

Communication is the key to developing and nurturing the trust in a doctor-patient relationship. So, if you are

Failing to do so might put you at risk for a medical malpractice claim.

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Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

REVIEW ARTICle

Anovulation and Infertility: Focus on Clomiphene Citrate and N-acetylcysteine for Ovulation Induction Anita Kant

Abstract Infertility is fast becoming a significant health challenge in India. Anovulation is one of the important causes of female factor infertility and disorders of anovulation are responsible for nearly 30% of infertility. Polycystic ovary syndrome (PCOS) is the commonest cause of anovulatory infertility. Clomiphene citrate, an antiestrogen, is the first-line treatment for anovulatory PCOS and also the first choice for ovulation induction therapy with hypothalamic-pituitary dysfunction as the underlying cause.

Treatment with clomiphene citrate tends to increase ovulation and pregnancy rates. Clinical efficacy evaluations suggest that clomiphene citrate improves live birth rate and clinical pregnancy rate among women with PCOS. N-acetylcysteine (NAC), a mucolytic drug with insulin sensitizing properties, is a promising adjuvant to clomiphene citrate for ovulation induction in PCOS patients.

Keywords: Infertility, ovulation induction, clomiphene citrate, N-acetylcysteine, polycystic ovary syndrome, anovulation

T

he problem of infertility is widely prevalent across the globe. According to a systematic analysis of 277 health surveys, in the year 2010, nearly 48.5 million couples failed to have a child after 5 years, worldwide. The global estimates of primary and secondary infertility have not changed much between 1990 and 2010.1 A recent Indian study conducted among couples in Ambala (urban population) noted the prevalence of primary infertility as 6.1%, and that of secondary infertility as 5.7%. Among women with primary infertility, ovulatory factor surfaced as the commonest cause.2

A case-control study by Saoji3 stated that primary infertility is common among women in urban areas.

The study also suggested that the most significant risk factors for primary infertility included higher education, age at marriage >25 years, deferral of childbearing for â&#x2030;Ľ1 year, obesity, polycystic ovary syndrome (PCOS), irregular menstrual pattern, endometriosis, sexually transmitted infection (STI) and age at menarche >14 years.

Infertility is fast becoming a significant health challenge in our country.

Anovulation Anovulation is one of the important causes of female factor infertility. Disorders of anovulation are *Director, Gynecology and Obstetrics

Asian Institute of Medical Sciences, Faridabad, Haryana

responsible for nearly 30% of infertility and are often characterized by irregular periods (oligomenorrhea) or absence of periods (amenorrhea). Anovulation can be treated either medically or surgically, depending upon the cause for anovulation.4 The common causes for anovulation include:4 zz Causes suitable for ovulation induction zz Hypothalamic-pituitary causes: Hypogonadotropic hypogonadism, hyperprolactinemia zz Ovarian causes: PCOS. zz Causes not suitable for ovulation induction zz Premature ovarian failure zz Genetic disorders.

PCOS seems to be the commonest cause of anovulatory infertility, accounting for nearly 75% of women having infertility due to anovulation.5 PCOS presents with hirsutism, acne, alopecia and irregular menstruation.

Obesity is commonly associated with PCOS.6 The syndrome has the following characteristics:5 zz Abnormal ovarian morphology. zz Abnormal steroidogenesis - increased ovarian production of androgens besides increased production of progesterone and estradiol. zz Hyperinsulinemia - seen in nearly 80% of obese women and 30-40% of women of normal weight with PCOS. zz Abnormal gonadotropin secretion - increased serum luteinizing hormone (LH) with ultrasonically detected polycystic ovary.

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Review article Managing Anovulatory Infertility The goal of treatment is to correct the underlying disorders such as hyperprolactinemia, hypothyroidism and adrenal disorders first. Lifestyle modifications, including correction of body mass index (BMI), smoking cessation and minimalizing alcohol consumption, play a significant role in treatment success.6 The options for ovulation induction and fertility treatment in women with PCOS include:7 zz Weight loss, exercise and lifestyle modifications zz Clomiphene citrate zz Metformin zz Gonadotropins zz Ovarian drilling zz In vitro fertilization (IVF).

Ovulation Induction: Cause-specific Treatment Weight change: Underweight women (BMI <18 kg/m2) should be advised to gain weight before offering infertility treatment. Likewise, obese women (BMI >30 kg/m2) should be advised to lose weight.4 In women with PCOS, excess body fat tends to increase insulin resistance. In these women, weight loss can potentially improve ovarian function and the hormonal abnormalities associated with obesity.5 Treating hyperprolactinemia: Dopamine agonists such as bromocriptine, cabergoline and quinagolide are prescribed to these patients.6 Once prolactin levels reach below 1,000 IU/L, the menstrual periods often return and about 70-80% of women begin to ovulate.4 Treating hypothyroidism: Infertile women with subclinical thyroid dysfunction tend to have anovulatory disorders.6 Thyroxine replacement corrects hypothyroidism and brings thyroid-stimulating hormone (TSH) and prolactin levels back to normal.4 Medical Induction of Ovulation Gonadotropin-releasing hormone: Women with a purely hypothalamic cause for amenorrhea are treated with pulsatile gonadotropin-releasing hormone.

A pulse of gonadotropin-releasing hormone is delivered subcutaneously every 90 minutes, which results in unifollicular ovulation.4 8

Antiestrogen therapy: It is close to 5 decades now that clomiphene citrate has been the choice of therapy for ovulation induction.6 Clomiphene citrate has been the first-line treatment for anovulation on account of hypothalamic-pituitary dysfunction associated with normal basal levels of endogenous estradiol.

Nearly 80% of these subjects are oligo- or anovulatory due to PCOS.4 Tamoxifen is another potential agent for treating anovulation.6 Gonadotropins: Patients who remain anovulatory despite antiestrogen therapy are treated with exogenous gonadotropins.4 Insulin sensitizers: Insulin resistance is linked with hyperandrogenism in PCOS patients. As a result, insulin sensitizers have found use in ovulation induction. A decrease in insulin resistance might cause a reduction in ovarian dysfunction and improve ovarian responsiveness to follicle-stimulating hormone (FSH).4 Aromatase inhibitors: Aromatase inhibitors, such as anastrozole and letrozole, have been used for ovulatory disorders and for superovulation and have shown promising results.4 Clomiphene Citrate for Ovulation Induction How does Clomiphene Citrate Work?

Clomiphene citrate, an antiestrogen, is the first-line treatment for anovulatory PCOS. It is the first choice for ovulation induction therapy where the cause is hypothalamic-pituitary dysfunction.4,6 Antiestrogens promote the release of gonadotropin from the pituitary gland as they occupy the estrogen receptors in the hypothalamus. This interferes with the normal feedback mechanisms, i.e., blocking the negative feedback effect of estradiol. As a result, there is increased FSH secretion that prompts follicular growth.6 Clomiphene citrate, a nonsteroidal compound, is administered orally and is relatively cheaper than some of the injectable alternatives.4 Clomiphene citrate instigates a discharge of FSH from the anterior pituitary, which encourages ovulation and pregnancy in euestrogenic anovulatory women. Clomiphene citrate blocks the estrogen receptors at the level of the hypothalamus.4 It blocks the negative feedback effect of estradiol and stimulates gonadotropin secretion from the pituitary

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

Review article gland. This gives way to follicle selection and estrogen production, resulting in a midcycle LH surge. Of note, in patients treated with clomiphene citrate, exogenous human chorionic gonadotropin (hCG) is not required for follicle rupture, unless ovulation does not occur despite the development of large follicles.8

Average number of follicles was 2.5 ± 1.65 in letrozole group and 2.36 ± 1.4 in clomiphene citrate group. β-hCG was positive in 20.8% in letrozole and 22.6% in clomiphene citrate group. Pregnancy rate was higher in clomiphene citrate group. There was no difference in rate of abortion between the two groups.

What is the Optimal Dosage of Clomiphene Citrate?

Clomiphene Citrate for Ovulation Induction in Women with PCOS

Clomiphene citrate is given orally in a dose of 50-250 mg/day for a period of 5 days starting from Day 2, 3, 4 or 5 of spontaneous or progestagen-induced bleeding. It is started with the lowest dose and the dose is increased in increments of 50 mg/day per cycle until the attainment of an ovulatory cycle. The starting time of the drug does not affect the outcomes,4,8 50 mg/day is the recommended starting dose; nearly half of the pregnancies are achieved with this dose.

With treatment initiation on Day 2, serum progesterone is measured on Days 21 and 28 of the cycle.

As mentioned earlier, PCOS is closely linked with anovulatory infertility. Clomiphene citrate is frequently used in patients with PCOS for ovulation induction.4 Most guidelines recommend clomiphene citrate as firstline therapy for PCOS patients.11 Brown and colleagues12 conducted a review to determine the effectiveness of antiestrogen agents in women with subfertility associated with anovulation, possibly caused by PCOS. Clomiphene citrate was effective in increasing pregnancy rate compared to placebo (OR 5.8). In another review by Tang et al,13 clomiphene citrate improved live birth rate (pooled OR 0.3, 95% confidence interval [CI] 0.17-0.52, 2 trials, 500 women) and clinical pregnancy rate (pooled OR 0.34, 95% CI 0.21-0.55, 2 trials, 500 women) among obese women, as compared to metformin.

Clinical Efficacy of Clomiphene Citrate in Ovulation Induction

Treatment with clomiphene citrate has been associated with an ovulation rate of 73% and a pregnancy rate of 36%.4 In well-selected patients with no other causes of infertility, the pregnancy rate can be as high as 60% after 6 cycles and 97% after 10 cycles.8 The administration of clomiphene citrate leads to increased release of pituitary gonadotropins resulting in follicular recruitment. There is continued secretion of estradiol, selection of the dominant follicle and ovulation after stopping the drug.9 Hughes et al9 reviewed published studies to assess the effects of clomiphene citrate on ovulation and pregnancy in women with oligo-ovulatory subfertility. Treatment with clomiphene citrate was associated with increased ovulation, as compared to placebo. The odds ratio (OR) for high doses (50-250 mg/day) was 6.82, while that with low doses (10 mg/day) was 1.29.

Clomiphene citrate was associated with an increased pregnancy rate per treatment cycle (OR 3.41).

Zadehmodares et al conducted a study to compare the effect of clomiphene citrate and letrozole in ovulatory stimulation in infertile women under intrauterine insemination (IUI). Patients were either given 5 mg letrozole daily or 100 mg clomiphene citrate daily for 5 days starting on Day 3 of their menses.

10

Badawy et al14 investigated the impact of luteal phase administration of clomiphene citrate for ovulation induction in women with PCOS. In all, 212 women (438 cycles) with PCOS were included in the study. Patients were divided into two groups: The early clomiphene citrate group received 100 mg clomiphene citrate daily starting the next day after finishing medroxyprogesterone acetate for 5 days (110 patients, 227 cycles); the late clomiphene citrate group received 100 mg clomiphene citrate daily for 5 days starting on Day 3 of menses (102 patients, 211 cycles). There were more ovulating patients in the early clomiphene citrate group (59.1% vs. 51.9%).

The total number of follicles and the number of follicles >14 mm and >18 mm during stimulation were higher in the early clomiphene citrate group.

Furthermore, the endometrial thickness at the time of hCG administration was 9.1 ± 0.23 in the early clomiphene citrate group; significantly greater than the late clomiphene citrate group (8.2 ± 0.60 mm). Pregnancy rate was 20.9% in the early clomiphene citrate group compared to 15.7% in the late clomiphene citrate group. Therefore, early

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

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Review article administration of clomiphene citrate in patients with PCOS was found to result in more follicular growth and endometrial thickness and a higher pregnancy rate. Ding et al15 also suggested in a recent a systematic review and meta-analysis that luteal phase clomiphene citrate could be a promising method for ovulation induction in women with PCOS compared to conventional clomiphene citrate administration.

In a comparison of letrozole and clomiphene citrate

by Roy et al,16 among patients with anovulatory PCOS with infertility, the mean number of dominant follicles was 1.86 ± 0.26 and 1.92 ± 0.17 in letrozole and clomiphene citrate groups, respectively. Number of ovulatory cycle in letrozole group was 196 (66.6%) versus 216 (67.9%) in clomiphene citrate group.

The mean estradiol level was significantly higher in clomiphene citrate group (364.2 ± 71.4 pg/mL) compared to letrozole group (248.2 ± 42.2 pg/mL).

Letrozole and clomiphene citrate had comparable ovulation rate.

A meta-analysis compared the clinical efficacy and safety of letrozole with clomiphene citrate for ovulation induction in women with PCOS. Six randomized controlled trials involving 841 patients were included.

The number of mature follicles per cycle was lower with letrozole (standardized mean difference −1.41; 95% CI −1.54 to −1.28) compared with clomiphene citrate.

There were no significant differences in pregnancy rate (relative risk [RR] 0.97; 95% CI 0.79-1.18), abortion rate (RR 1.38; 95% CI 0.48 to −3.96) and multiple pregnancy rate (RR 0.34; 95% CI 0.07 to −1.72) between the two groups.17 N-acetylcysteine as an Adjuvant to Clomiphene Citrate N-acetylcysteine (NAC) is a mucolytic drug with insulin sensitizing properties. It has several biological effects including improved pregnancy rate.18 NAC is an antioxidant with anti-apoptotic effects. It preserves vascular integrity and decreases homocysteine levels.19 In patients with PCOS, NAC has been shown to improve the parameters of glucose control. It was found to reduce insulin levels and increase peripheral insulin sensitivity. The antioxidant effects of NAC appear to improve the level of circulating insulin and insulin sensitivity in PCOS patients with hyperinsulinemia.20 10

A study compared the effects of clomiphene citrate plus NAC with clomiphene citrate alone for inducing ovulation in patients with PCOS. Ovulation rate improved with the addition of NAC (17.9% vs.

52.1%). The number of mature follicles was more in the NAC group (2.1 ± 0.88 vs. 3.2 ± 0.93). The mean estradiol levels at the time of hCG injection, serum progesterone levels on Days 21-23 of the cycle and the endometrial thickness were also improved in the NAC group.21 Maged et al22 determined the adjuvant effect of metformin and NAC to clomiphene citrate in ovulation induction in PCOS patients.

Patients in Group I were given clomiphene citrate only, Group II received clomiphene citrate plus NAC and Group III received clomiphene citrate plus metformin.

A significant difference was found between Group II and other two groups regarding average number of ovulatory follicles >18 mm (2.25 vs. 1.75 and 1.89, respectively).

A significant difference was also noted between Group II and other two groups regarding pregnancy rate per patient (20% vs. 10% and 10%, respectively).

Endometrial thickness was also greater in Group II as compared to the other two groups. NAC was thus found to improve ovulation and pregnancy rates in PCOS patients and was beneficial for endometrial thickness as an adjuvant to clomiphene citrate.

In another study, NAC appeared to be a safe and welltolerated adjuvant to clomiphene citrate for ovulation induction. It improved ovulation and pregnancy rates in PCOS patients. The number of follicles >18mm and the mean endometrial thickness on the day of hCG administration were significantly higher in the clomiphene citrate + NAC group. The ovulation and pregnancy rates were also significantly higher in this group.23 Conclusion Infertility is widely prevalent globally and is fast becoming a significant health challenge in India.

Anovulation is a significant cause of female factor infertility and PCOS is the commonest cause of anovulatory infertility. Treating the underlying disorders including hyperprolactinemia, hypothyroidism and adrenal disorders is important in these patients.

Clomiphene citrate is the first-line treatment for anovulatory PCOS and the first choice for ovulation induction therapy where the cause is hypothalamic-

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

Review article pituitary dysfunction. Clomiphene citrate provokes a discharge of FSH from the anterior pituitary thus promoting ovulation and pregnancy in euestrogenic anovulatory women. In well-selected patients with no other causes of infertility, the pregnancy rate with clomiphene citrate can be as high as 60% after 6 cycles and 97% after 10 cycles. Treatment with clomiphene citrate is known to increase ovulation rate and pregnancy rate. Most guidelines recommend clomiphene citrate as first-line therapy for PCOS patients. Clinical efficacy evaluations suggest that clomiphene citrate improves live birth rate and clinical pregnancy rate among women with PCOS. NAC is a promising adjuvant to clomiphene citrate for ovulation induction in PCOS patients.

It reduces insulin levels and increases peripheral insulin sensitivity in patients with PCOS. Adding NAC to clomiphene citrate improves ovulation and pregnancy rates in PCOS patients.

References 1. Mascarenhas MN, Flaxman SR, Boerma T, Vanderpoel S, Stevens GA. National, regional, and global trends in infertility prevalence since 1990: a systematic analysis of 277 health surveys. PLoS Med. 2012;9(12):e1001356.

2. Mittal A, Yadav S, Yadav SS, Bhardwaj A, Kaur R, Singh P, et al. An epidemiological study of infertility among urban population of Ambala, Haryana. IJIMS. 2015;2(4): 124-30.

3. Saoji AV. Primary infertility problems among female have been a source of concern in India lately. IJMHS. 2014;4(1):332-40.

4. Katsikis I, Kita M, Karkanaki A, Prapas N, Panidis D. Anovulation and ovulation induction. Hippokratia.

2006;10(3):120-7.

5. Homburg R. The management of infertility associated with polycystic ovary syndrome. Reprod Biol Endocrinol.

2003;1:109.

6. Gorthi S, Balen AH, Tang T. Current issues in ovulation induction. TOG. 2012;14(3):188-96.

7. Vause TD, Cheung AP, Sierra S, Claman P, Graham J, Guillemin JA, et al; Society of Obstetricians and Gynecologists of Canada. Ovulation induction in polycystic ovary syndrome. J Obstet Gynaecol Can. 2010;32(5): 495-502.

8. Messinis IE. Ovulation induction: a mini review. Hum Reprod. 2005;20(10):2688-97.

9. Hughes E, Collins J, Vandekerckhove P. Clomiphene citrate for ovulation induction in women with oligo-amenorrhoea. Cochrane Database Syst Rev. 2000;(2):CD000056.

10. Zadehmodares S, Niyakan M, Sharafy SA, Yazdi MH, Jahed F. Comparison of treatment outcomes of infertile women by clomiphene citrate and letrozole with gonadotropins underwent intrauterine insemination. Acta Med Iran. 2012;50(1):18-20.

11. Davidson R, Motan T, Korownyk C. Clomiphene for anovulatory infertility. Can Fam Physician.

2016;62(6):492.

12. Brown J, Farquhar C, Beck J, Boothroyd C, Hughes E. Clomiphene and anti-oestrogens for ovulation induction in PCOS. Cochrane Database Syst Rev. 2009;(4):CD002249.

13. Tang T, Lord JM, Norman RJ, Yasmin E, Balen AH. Insulinsensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility. Cochrane Database Syst Rev. 2012;(5):CD003053.

14. Badawy A, Inany H, Mosbah A, Abulatta M. Luteal phase clomiphene citrate for ovulation induction in women with polycystic ovary syndrome: a novel protocol. Fertil Steril.

2009;91(3):838-41.

15. Ding N, Chang J, Jian Q, Liang X, Liang Z, Wang F. Luteal phase clomiphene citrate for ovulation induction in women with polycystic ovary syndrome: a systematic review and meta-analysis. Gynecol Endocrinol. 2016;32(11):866-71.

16. Roy KK, Baruah J, Singla S, Sharma JB, Singh N, Jain SK, et al. A prospective randomized trial comparing the efficacy of letrozole and clomiphene citrate in induction of ovulation in polycystic ovarian syndrome. J Hum Reprod Sci. 2012;5(1):20-5.

17. He D, Jiang F. Meta-analysis of letrozole versus clomiphene citrate in polycystic ovary syndrome. Reprod Biomed Online. 2011;23(1):91-6.

18. Youssef G, Makin B, Ali AM, Waly M, Alaa N, Abou-Setta A. N-acetyl-cysteine in anovulatory women: The impact of postcoital test. Middle East Fertil Soc J. 2006;11(2): 109-12.

19. Agarwal A, Aponte-Mellado A, Premkumar BJ, Shaman A, Gupta S. The effects of oxidative stress on female reproduction: a review. Reprod Biol Endocrinol.

2012;10:49.

20. Sekhon LH, Gupta S, Kim Y, Agarwal A. Female infertility and antioxidants. Current Women’s Health Reviews.

2010;6(2):84-95.

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Review article 21. Badawy A, State O, Abdelgawad S. N-Acetyl cysteine and clomiphene citrate for induction of ovulation in polycystic ovary syndrome: a cross-over trial. Acta Obstet Gynecol Scand. 2007;86(2):218-22.

22. Maged AM, Elsawah H, Abdelhafez A, Bakry A, Mostafa WA. The adjuvant effect of metformin and N-acetylcysteine to clomiphene citrate in induction of ovulation in patients

with polycystic ovary syndrome. Gynecol Endocrinol.

2015:1-4.

23. Salehpour S, Sene AA, Saharkhiz N, Sohrabi MR, Moghimian F. N-Acetylcysteine as an adjuvant to clomiphene citrate for successful induction of ovulation in infertile patients with polycystic ovary syndrome. J Obstet Gynaecol Res. 2012;38(9):1182-6.

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Clinical Study

Knowledge and Attitude of Infertile Couples Attending IRM: A Prospective Observational Study Akshaya Kumar Mahapatro*, Indumathi Joy†, Kundavi Shankar‡, Thankam Varma#

Abstract Objective: The purpose of this present study was to evaluate the knowledge of infertile couples about the risk factors associated with infertility and to assess their attitude towards various methods of infertility treatment.

Study design: This prospective observational study of knowledge and attitude of infertile couple was carried out in our hospital. The present study was conducted on all the subfertile couples (n = 223) who presented for an initial assessment to our outpatient department (OPD) by giving a questionnaire paper containing 16 knowledge-based and 7 attitude-based questions in English. Their level of knowledge was assessed by giving score 1 to correct answer, zero for wrong and those do not know the answer. Their level of knowledge was scored as inadequate (scored <50%), moderately adequate (scored >50 to <75%) and adequate (>75%) regarding infertility. Result: Out of the 223 couples, prevalence of primary and secondary infertility was 73% and 27%, respectively. The mean duration of infertility was 4.46 ± 3.32 years. On scoring their level of knowledge, (n = 115) had inadequate, (n = 101) had moderately adequate and (n = 7) had adequate knowledge. There was no statistically significant difference found (p = 0.97) in the knowledge in relation to their educational qualification and type of infertility (p = 0.657) among the participants. Conclusion: We discovered that the knowledge about the risk factors associated with infertility is generally limited among the participants, in spite of their higher education level and there needs to be an educative counseling session in all the infertility clinics to create an awareness among the married couples.

Keywords: Infertility, knowledge, attitude, assisted reproductive technique, counseling, awareness

I

t is the dream of every married couple to have a child, which will bring happiness and joy into their life. Most people assume that they will have children when they want and spend time and energy trying to get pregnant, but get frustrated then they find that to have a baby when wanted is not so simple.1 Infertility is a disease of the reproductive system, which affects both men and women with almost equal frequency.2 The World Health Organization (WHO) defines primary infertility as inefficiency to conceive after a year of unprotected sex and secondary if not conceived following previous pregnancy. Infertility is a global phenomenon that affects between 60 million *Post Doctoral Fellowship † Associate Consultant ‡ Senior Consultant # Medical Director Institute of Reproductive Medicine, Madras Medical Mission, Chennai, Tamil Nadu Address for correspondence Dr Akshaya Kumar Mahapatro Vijay Shanthi Infiniti, Tower 1-6A, Chettipedu, Chennai, Tamil Nadu E-mail: dr.aks73@gmail.com

to 168 million people worldwide.3 Psychologically, the infertile woman exhibits significantly higher psychopathology in the form of tension, hostility, anxiety, depression, self-blame and suicidal ideation.4 Social stigma regarding infertility is especially common across South Asia. For e.g., in Andhra Pradesh, India 70% of women experiencing infertility reported being punished with physical violence for their failure.5 A global survey of almost 17,500 women (mostly of childbearing age) from 10 countries revealed that knowledge regarding fertility and biology of reproduction was poor.6 Many women have little awareness of the period of the month in which they are most fertile and when to seek treatment.7,8 The risk factors for infertility include obesity, advanced maternal age, menstrual irregularities sexually-transmitted infections, smoking, alcohol consumption and many others.9 Increasing the level of knowledge of these factors may help to decrease the incidence of infertility by allowing couples to avoid certain risk factors that might lead to it. This knowledge may also help wider society to understand and empathize with the infertile couple,

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clinical study which may lead to a decrease in the psychological burden to those affected.10 Moreover, patient education has been found to be a key aspect of patient satisfaction with infertility care.11,12 Psychological distress is seen as both cause and effect of infertility and quite common in infertile couple.13 Researches exploring the knowledge, behaviors, perceptions and practices regarding infertility or certain treatment options have been carried out in developed countries but very limited data is available from the Indian population despite high prevalence of infertility. This present study was conducted in our hospital to evaluate the knowledge of infertile couples attending to outpatient department (OPD) about the risk factors associated with infertility and to assess their attitude towards various methods of infertility treatment.

Material and Methods This prospective observational study of knowledge and attitude of infertile couples was carried out in our hospital. The present study was conducted during the period of November 2014 to August 2015, on all the infertile couples (n = 223) who presented for an initial assessment to our OPD. Recruitment was based on the couple’s willingness to answer the questionnaire in English. Couples, who were unable to read English were excluded from the study. The couples were informed about the study and offered knowledge- and attitude-based questionnaires during clinical history taking. The questionnaire contains 16 knowledgebased and 7 attitude-based questions. Their response was collected immediately during history taking.

Their level of knowledge was assessed by giving score 1 to correct answer, zero for wrong and those do not know the answer. Those who scored <50% were considered to have inadequate, those with scores >50 to <75% as moderately adequate and those with scores >75% adequate knowledge regarding infertility.

Statistical analysis was done by frequency, percentage calculation and Chi-square test using SPSS software.

Results Demographic Information

Out of 223 couples, the prevalence of primary infertility was (n = 162) and that of secondary infertility was (n = 61). The mean duration of infertility was 4.46 ± 3.32 years. Out of 223 female partners, the mean female age (years) was 30.03 ± 4.25. Among 223 female partners, 108 (48.4%) were graduates and 99 (44.4%) were postgraduates. Mean male age was 33.94 ± 4.73 years.

One hundred thirty-one (58.7%) of male partners were graduates and 78 (35%) were postgraduates (Table 1).

Knowledge and Misconceptions Regarding Related to Infertility

Table 2 shows the response of infertile towards risk factors associated with infertility. In our study, most of the patients (>70%) of respondents were aware about the common risk factors such as advanced age, obesity, irregular menstrual cycle, stress, environmental pollutant, fertile period and advantages of regular exercise. But less than 50% of respondents were aware about the other common risk factors such as genital tracts infection which leads to tubal block, common symptoms of endometriosis, which also leads to infertility.

In our study, 41% had misconception that use of oral contraceptive affect their fertility status and 48% were not aware about the OCP role, this misconception may have led to unwanted pregnancy loss. About 61% respondents were aware that increase in frequency of intercourse increases the chance of pregnancy rate, but 70% of the respondents had the false belief that lying down in bed for long time after sexual intercourse increases the chances of pregnancy. We found 33% of respondents had misconception that delay in pregnancy runs in families and 30% had no knowledge about the

Table 1. Demographic Data Parameters Mean age of female (years)

30.03 ± 4.25

Range 20-43 years

Mean age of male (years)

33.94 ± 4.73

Range 26-48 years

Education of female

Graduates - 108 (48.4%)

Postgraduates - 99 (44.4%)

Education of male

Graduates 131 (58.7%)

Postgraduates - 78 (35%)

Type of infertility

Primary - 162 (72.6%)

Secondary - 61 (27.4%)

4.46 ± 3.32

Range 1-17 years

Mean duration of infertility

14

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clinical study Table 2. Response of Couple About Knowledge-based Questionnaire Yes

No

Donâ&#x20AC;&#x2122;t know

Do you think increasing age in women may delay to achieve pregnancy?

Questions

167 (74.9%)

38 (17%)

18 (8.1%)

Does obesity in a women delay the fertility?

173 (77.6%)

23 (10.3%)

27 (12.1%)

Do you think irregular cycle may be a cause for delay in achieving pregnancy?

180 (80.7%)

21 (9.4%)

22 (9.9%)

Does pain in the lower abdomen during periods and during sexual intercourse delays pregnancy?

44 (19.7%)

76 (34.1%)

103 (46.2%)

What do you mean by fertile period in a women having regular cycle?

166 (74.4%)

39 (17.5%)

18 (8.1%)

Do you think foul smelling discharge P/V in a women is a cause for pregnancy delay?

39 (17.5%)

58 (26%)

126 (56.5%)

Does OCP use in past delay conception in the women?

92 (41.3%)

29 (13%)

102 (55.7%)

Do you think frequency of intercourse increases the chance of pregnancy?

136 (61%)

56 (25.1%)

31 (13.9%)

Does lying down in bed for long time after sexual intercourse increase the pregnancy chance?

157 (70.4%)

30 (13.5%)

36 (16.1%)

Do you think stressful life in a woman affects her fertility?

202 (90.6%)

10 (4.5%)

11 (4.9%)

Do you think delay in pregnancy runs in families?

73 (32.7%)

83 (37.2%)

67 (30%)

Do you think exposure to environmental pollutant reduce fertility?

101 (45.3%)

46 (20.6%)

76 (34.1%)

Do you think regular exercise by a woman increases her fertility?

171 (76.7%)

20 (9%)

32 (14.3%)

Does smoking reduce sperm parameters in men?

200 (89.7%)

7 (3.1%)

16 (7.2%)

Do you think increasing age in men reduces fertility?

126 (56.5%)

58 (26%)

39 (17.5%)

Do you think a women conceived previously might have problems to conceive again?

69 (30.9%)

117 (52.5%)

37 (16.6%)

Table 3. Response of Couple About Attitude-based Questionnaire Questions

Yes

No

18 (8.1%)

205 (91.9%)

Who do you think it should be investigated first?

H - 7 (3.1%)

W - 14 (6.3%)

Both - 202 (90.6%)

Who is being blamed for infertility in the society?

H - 1 (0.4%)

W - 123 (55.2%)

Both - 99 (44.4%)

Do you think it is socially acceptable to have a test-tube baby?

161 (72.2%)

58 (26%)

NW - 4 (1.8%)

If a couple cannot have a child, do you think they should adopt?

169 (75.8%)

47 (21.1%)

NW - 7 (3.1%)

Do you think your husband should donate sperm to help an infertile couple to have a baby?

121 (54.3%)

94 (42.1%)

NW - 8 (3.6%)

Are you interested to donate your egg to help an infertile couple to have a baby?

107 (48%)

108 (48.4%)

NW - 8 (3.6%)

Do you think infertility is a disease?

hereditary nature of infertility. In our study, 90% of female partners were aware that smoking reduces the sperm parameters in men and 57% were aware that increased age in men also reduces fertility.

Attitude Towards Infertility and Its Social Consequences

Table 3 shows the response of infertile patients to some attitudinal statements towards infertility and its social consequences. In our study, 92% of patients did not want to label infertility as a disease and 91% correctly were that it was a problem of the couple and

needed investigation of the couple simultaneously.

In our study, we found that 55% of females were blamed by the family members and society in spite of the fact that the cause may be related to any one of the partner. In our study, we found >70% patients were aware about the mode of treatment available such as in vitro fertilization (IVF) and adoption. Interestingly, we found that 54% of infertile couples husbandâ&#x20AC;&#x2122;s were willing to help infertile couple by sperm donation but response of infertile females towards egg donation was equivocal (48%). Tables 4-6 showing about their level of knowledge and its correlation.

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clinical study Table 4. Correlation of Type of Infertility with Levels of Knowledge Type of infertility

Inadequate knowledge

Moderately adequate knowledge

Adequate knowledge

P value

Primary

85 (52.46%)

72 (44.44%)

5 (3.08%)

NS (0.657)

Secondary

30 (49.18%)

29 (47.54%)

2 (3.27%)

Table 5. Female Education with Levels of Knowledge Education

Inadequate knowledge

Moderately adequate knowledge

Adequate knowledge

P value

High school

6 (2.7%)

5 (2.2%)

0

NS (0.977)

Higher secondary

3 (1.3%)

2 (0.9%)

0

Graduates

56 (25.1%)

49 (22%)

3 (1.3%)

Postgraduates

50 (22.4%)

45 (20.2%)

4 (1.8%)

Table 6. Levels of Knowledge Knowledge

No.

Percentage (%)

Inadequate knowledge

115

51.6

Moderately adequate knowledge

101

45.3

Adequate knowledge

7

3.1

Discussion Although there is widespread acknowledgment of the importance of patient education within the infertility field, there is limited research into the knowledge which infertile patients actually possess and also the way they gain infertility-related information in resource poor settings where health literacy is typically low. According to Bunting and Boivin et al 2007,14 knowledge about fertility issues is a core motivator for fertility problems. A Global survey revealed inadequate knowledge of women regarding fertility;6 our study also demonstrated that the participants had inadequate knowledge about the risk factors associated with infertility. But the knowledge regarding the potential risk factors associated with infertility was high. In our study, 75% of female partners were aware that increasing age results in decline in fertility which is similar to the study by Bunting and Boivin et al (2008),10 but there was lack of awareness of the significance of age for declining fertility among childless Canadian women15 and Australian women,16 and among the university students in Sweden.17 In our study, we found that 77% were aware that obesity has negative effects on fertility which is similar to Abolfotouh et al,18 Brannian et al,19 Bunting et al study (2013),20 and Daniluk et al study (2015).15 In our study, we found that 81% women were aware that irregular cycles may be a cause for delay in 16

pregnancy, but in Abolfotouh et al18 study only 64% were aware about it. In our study, only 20% of female partner considered dysmenorrhea and dyspareunia as a risk factor for fertility but no other study considers it as a risk factor. It is crucial to know about the fertile period for a women, when she should try to conceive.

In our study, fertile period was well-known to 74% participants similar to Linda Rae Bennet9 study, but in Ali et al21 and an Australian study only 46% and 32%, respectively were aware about it. The higher percentage in our study could be due to higher educational qualification of female partners and prevalence of more referral patients. In our study, 82.5% of female partners were not aware about genital tract infections as a risk factor for infertility. Since, diagnosis and treatment of genital tract infections can prevent the major sequel, the tubal block, awareness of genital tract infection as a risk factor is highly required in our society. In our study, 41.3% believed that use of OCP affects fertility and 107 (55.7%) didnâ&#x20AC;&#x2122;t know its effect, but in Ali et al21 study, 61% correctly highlighted use of OCP affecting fertility. Study conducted by Bunting10 also highlighted that participants had a false belief that use OCP as a risk factor for in fertility.

In our study, 70% female partners had belief that lying in bed after intercourse increases the pregnancy chance, which is similar to Bunting and Boivin et al study in which participants believed in the myth that lying down for 10 minutes after sex increases the pregnancy rate.10 A randomized controlled trial by Custers et al22 at Netherland and Orief et al, Egypt23 reported that 15 minutes of immobilization after intrauterine insemination (IUI) significantly improves pregnancy rate as compared to immediate mobilization.

From a psychological standpoint, women facing

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

clinical study infertility exhibit significantly more tension, hostility, anxiety, depression, self-blame and suicidal ideation.4 In our study, 90% females were aware about the negative effect of stress on fertility, which is had similar to other studies. In our study, only 33% of couple belief that infertility runs in family but no other study commented on the hereditary nature of fertility.

In our study, 45% couple believed that environmental pollutants reduce fertility chance. In our study, 77% women were aware that regular moderate exercise increases the fertility rate similar to Bunting and Boivin et al study but in Ali et al study only 13% participant knew about it. In our study, 90% of women thought that smoking reduces the sperm parameters, which is similar to other studies by Bunting and Boivin et al10 and Daniluk and Koert study.15 In our study, 56.5% women thought that increasing manâ&#x20AC;&#x2122;s age reduces the chance of fertility, which is similar to Daniluk and Koert et al study.15 In our study, we found that 52% women had the misconception that in case of previous spontaneous conception there will be no problem for further conception; due to this false belief there was delay in their consultation.

Considering attitude of people in our study, 92% did not want to label infertility as a disease but in Ali et al study, only 56% opined that infertility is not a disease. In our study, we found 90% women answered that both partner should be investigated at same time, which is similar to Ali et al study21 and Bennett study.24 Unnecessary blame on a woman for infertility can potentially affect her self-esteem and might socially cripple her. In our study, we found that 55% of female partners thought that they were blamed by society for infertility and this is similar to Luna et al25 study in Latin America, but the percentage was higher than that of our study in studies by Ali et al21 and Sami et al26 in Pakistan. In our study, 72% agreed that to have a test tube baby is socially acceptable which is similar to Adashi et al study.8 Since, child adoption is an available option for infertile couples, many couples with incurable infertility in advanced countries are willing to adopt babies but are limited by the few babies available for adoption.

In our study, we found that 76% infertile couples agreed for adoption as an option for infertile couples similar to other studies. In Kilic et al27 study, most of them stated adoption as the first choice if they had learned

that they would never have a child in their future life.

In Sohrabvand et al study,28 total 98.7% of responders opposed sperm donation. In a study by Hwang et al29 about the attitudes of infertile male patients toward use of artificial insemination by donor (AID) concluded about high acceptance of AID among infertile males.

Although IVF techniques have been providing hope to infertile couples, male and female gametes and a healthy woman with a healthy uterus are required to apply these techniques. Donation programs have become a resource for couples who cannot produce the requisite gametes.30 In our study, the attitude of infertile females towards egg donation was equivocal (50%), which was similar to Chliaoutakis et al study.31 In another study conducted in Turkey by Isikoglu et al,32 the proportion of positive respondents towards oocyte donation was nearly 85%. The proportions were 82.3% among fertile individuals and 86.7% among infertile ones.

Westlander et al33 reported that in their study group, infertile women were more in favor of donating oocyte compared to fertile ones. In our study, we considered all the risk factors responsible for infertility but other studies included few risk factors. No study considered endometriosis, heredity and chance of infertility in a previously normally conceiving women and there was previous no such study including South Indian women.

Limitations of the Study Only patients those were able to read English were included in spite of it not being the local language.

Most of the patients attending our OPD were referred or previous treatment failure cases. Most of the couple included in our study were well-educated.

Conclusion Infertility is a fairly common problem affecting 10-15% of the population. We discovered that the knowledge about infertility is generally limited among the participants. In spite of their higher education level, most of the couple coming to us had inadequate knowledge about the risk factors associated with infertility. In fact, there are a lot of misconceptions, such as OCPs can cause infertility. The cultural and religion perspective about ART is unclear, which has resulted in its reduced acceptability. Since, the prevalence of infertility is rising due to late marriages, career, stressful and altered lifestyles, we suggest there

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clinical study is a need for educative counseling sessions in all the infertility clinics to create an awareness among the married couples.

References 1. Holistic online com (online). 2000 [Cited 2007 Aug 10]; Available from URL: http://www.holisticonline.com/ remedies/infertility/inf_ introduction. htm.

2. Callahan LT, Caughey AB. Infertility and assisted reproductive technologies. In: Blueprints Obstetrics and Gynecology. 5th Edition, Lippincott Williams & Wilkins; 2008. pp. 275-89.

3. Neelofar S, Tazeen S. The cultural politics of gender for infertile women in Karachi, Pakistan. South Africa: InGender Studies Conference; 2006.

4. Fido A. Emotional distress in infertile women in Kuwait.

Int J Fertil Womens Med. 2004;49(1):24-8.

5. Daar A, Merali Z. Infertility and social suffering: the case of ART in developing countries. In: Vayena ERP, Griffin D (Eds.). Current Practices and Controversies in Assisted Reproduction. Geneva: World Health Organization; 2002.

6. What you never know about fertility. World Fertility Awareness Month; 2006.

7. Blake D, Smith D, Bargiacchi A, France M, Gudex G. Fertility awareness in women attending a fertility clinic.

Aust N Z J Obstet Gynaecol. 1997;37(3):350-2.

8. Adashi EY, Cohen J, Hamberger L, Jones HW Jr, de Kretser DM, Lunenfeld B, et al. Public perception on infertility and its treatment: an international survey. The Bertarelli Foundation Scientific Board. Hum Reprod. 2000;15(2): 330-4.

9. Namujju J. Knowledge, attitudes and practices towards infertility among adults 18-40 years in Kalisizo, Rakai District in Uganda. Uganda Scholarly Digital Library, Thesis, 2008. Available at: http://dspace.mak.ac.ug/ handle/123456789/972. Accessed on January 12, 2017.

10. Bunting L, Boivin J. Knowledge about infertility risk factors, fertility myths and illusory benefits of healthy habits in young people. Hum Reprod. 2008;23(8):1858-64.

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13. Negro-Vilar A. Stress and other environmental factors affecting fertility in men and women: overview. Environ Health Perspect. 1993;101 Suppl 2:59-64.

14. Bunting L, Boivin J. Decision-making about seeking medical advice in an internet sample of women trying to get pregnant. Hum Reprod. 2007;22(6):1662-8.

15. Daniluk JC, Koert E, Cheung A. Childless women’s knowledge of fertility and assisted human reproduction: identifying the gaps. Fertil Steril. 2012;97(2):420-6.

16. Hammarberg K, Setter T, Norman RJ, Holden CA, Michelmore J, Johnson L. Knowledge about factors that influence fertility among Australians of reproductive age: a population-based survey. Fertil Steril. 2013;99(2):502-7.

17. Skoog Svanberg A, Lampic C, Karlström PO, Tydén T. Attitudes toward parenthood and awareness of fertility among postgraduate students in Sweden. Gend Med. 2006;3(3):187-95.

18. Abolfotouh MA, Alabdrabalnabi AA, Albacker RB, Al-Jughaiman UA, Hassan SN. Knowledge, attitude, and practices of infertility among Saudi couples. Int J Gen Med. 2013;6:563-73.

19. Brannian JD. Obesity and fertility. S D Med. 201;64(7): 251-4.

20. Bunting L, Tsibulsky I, Boivin J. Fertility knowledge and beliefs about fertility treatment: findings from the International Fertility Decision-making Study. Hum Reprod. 2013;28(2):385-97.

21. Ali S, Sophie R, Imam AM, Khan FI, Ali SF, Shaikh A, et al. Knowledge, perceptions and myths regarding infertility among selected adult population in Pakistan: a cross-sectional study. BMC Public Health. 2011;11:760.

22. Custers IM, Flierman PA, Maas P, Cox T, Van Dessel TJ, Gerards MH, et al. Immobilisation versus immediate mobilisation after intrauterine insemination: randomised controlled trial. BMJ. 2009;339:b4080.

23. Orief YI, El-agwany AS, Darwish EAE, Salim NM. The effect of bed rest after intrauterine insemination on pregnancy outcome. Middle East Fertil Soc J. 2015;20: 11-5.

11. Schmidt L. Infertile couples’ assessment of infertility treatment. Acta Obstet Gynecol Scand. 1998;77(6): 649-53.

24. Bennett LR, Wiweko B, Bell L, Shafira N, Pangestu M, Adayana IB, et al. Reproductive knowledge and patient education needs among Indonesian women infertility patients attending three fertility clinics. Patient Educ Couns. 2015;98(3):364-9.

12. Souter VL, Penney G, Hopton JL, Templeton AA. Patient satisfaction with the management of infertility. Hum Reprod. 1998;13(7):1831-6.

25. Luna F. Assisted reproductive technologies in Latin America: some ethical and sociocultural issues. In: Vayena E, Rowe PJ, Griffin PD (Eds.). Medical, Ethical and Social

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26. Sami N, Ali TS. The cultural politics of gender for infertile women in Karachi, Pakistan: Proceedings of the FOTIM Gender Studies Conference; January 17-19, 2006; Pretoria, South Africa.

27. Kilic S, Ucar M, Yaren H, Gulec M, Atac A, Demirel F, et al. Determination of the attitudes of Turkish infertile women towards surrogacy & oocyte donation. Pak J Med Sci. 2009;25(1):36-40.

28. Sohrabvand F, Jafarabadi M. Knowledge and attitudes of infertile couples about assisted reproductive technology.

Iranian J Reprod Med. 2005;3(2):90-4.

29. Hwang DS, Jeon TG, Park HJ, Park NC. The attitudes of infertile male patients toward the use of artificial insemination by donor: a korean regional survey. Korean J Urol. 2014;55(2):134-9.

30. Baykal B, Korkmaz C, Ceyhan ST, Goktolga U, Baser I. Opinions of infertile Turkish women on gamete donation and gestational surrogacy. Fertil Steril. 2008;89(4): 817-22.

31. Chliaoutakis JE, Koukouli S, Papadakaki M. Using attitudinal indicators to explain the public’s intention to have recourse to gamete donation and surrogacy. Hum Reprod. 2002;17(11):2995-3002.

32. Isikoglu M, Senol Y, Berkkanoglu M, Ozgur K, Donmez L, Stones-Abbasi A. Public opinion regarding oocyte donation in Turkey: first data from a secular population among the Islamic world. Hum Reprod. 2006;21(1):318-23.

33. Westlander G, Janson PO, Tägnfors U, Bergh C. Attitudes of different groups of women in Sweden to oocyte donation and oocyte research. Acta Obstet Gynecol Scand.

1998;77(3):317-21.

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Clinical Study

Hypertensive Disorders in Pregnancy: An Obstetric Catastrophe Surya Malik*, Khushpreet Kaur†, Parneet Kaur‡

Abstract Objective: To study the contribution of hypertensive disorders in pregnancy in maternal and fetal morbidity and mortality and to study its relation with various maternal factors like antenatal care during pregnancy, socioeconomic status education and parity. Methods: The present study was conducted on a prospective basis for 1 year from 1st February 2011 to 31st January 2012 in the Dept. of Obstetrics and Gynecology, Govt. Medical College, Patiala, Punjab. All the cases with hypertensive disorders of pregnancy, presenting as obstetrical emergency were included in the study. A detailed history including age, parity, gestational age, antenatal care during pregnancy, socioeconomic status and obstetrical history, medical or surgical disorders was taken into account. Results: Hypertensive disorders of pregnancy contributed 35.32% of all the obstetrical emergencies. Various maternal complications that were encountered were abruptio placenta (23.6%), acute renal failure (2.25%), pulmonary edema (3.37%), HELLP syndrome (5.62%), coagulopathy (2.25%) and postpartum hemorrhage (13.48%). Maternal mortality was 3.45%. Fetal mortality was 33.33%. Conclusions: Through this study, it was concluded that hypertensive disorders of pregnancy is a leading cause of maternal morbidity and mortality. It is more common in unbooked cases with low socioeconomic status and poor access to antenatal care.

Keywords: Hypertensive disorders of pregnancy, HELLP syndrome

H

ypertensive disorders represent the most common medical condition of pregnancy affecting between 10 to 15% of all gestations and account for approximately a quarter of all antenatal admissions.1 According to World Health Organization’s (WHO’s) systematic review on maternal mortality worldwide, hypertensive disease remains a leading cause of direct maternal mortality. Together with hemorrhage and infection, hypertension forms the deadly triad that contributes to morbidity and mortality during pregnancy and child birth.2 Around 5,85,000 women die each year due to pregnancy related causes, 98% of these occur in developing countries. It is estimated that 13% of maternal deaths are due to hypertensive disorder of pregnancy particularly in eclampsia.3

Hypertensive disorders in pregnancy can be divided into four well-defined groups: *Junior Resident † Professor ‡ Associate Professor Dept. of Obstetrics and Gynecology Govt. Medical College, Patiala, Punjab Address for correspondence Dr Surya Malik A2A, House No. 159, Janakpuri West, New Delhi E-mail: surya85.sm@gmail.com

20

Gestational hypertension zz Pre-eclampsia, eclampsia zz Chronic hypertension zz Essential zz Secondary zz Pre-eclampsia superimposed hypertension. zz

on

chronic

Eclampsia is an extremely severe form of pre-eclampsia characterized by the sudden onset of generalized tonic-clonic seizures. Eclampsia occurs antepartum in 35-45%, intrapartum in 15-20% and postpartum in 35-45% of cases.4 Approximately 1 in 2,000 deliveries is complicated by eclampsia in developed countries, whereas the incidence in developing countries is estimated around 1 in 100 to 1 in 1,700 cases.5 In the developing countries, there is low utilization of both antenatal and intrapartum care and the patients present to the hospital only as a final resort.

The opportunity to detect women at the pre-eclamptic stage is therefore usually lost. In addition, the WHO estimates that only 40% of birth in developing countries take place in health facilities.6 Cases presenting with this morbid condition as emergency were included in the present study.

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

clinical study Methods The present study was conducted on a prospective basis for 1 year from 1st February 2011 to 31st January 2012 in the Dept. of Obstetrics and Gynecology, Govt. Medical College, Patiala, Punjab. All the cases with hypertensive disorder of pregnancy presenting as obstetrical emergency were included in the study.

A detailed history including age, parity, gestational age, antenatal care during pregnancy, socioeconomic status, obstetrical history, medical or surgical disorders was taken into account.

Results Hypertensive disorders in pregnancy has a major role in maternal and fetal morbidity and mortality.

In the present study, it is evident that hypertensive disorders in pregnancy were more common in the age Table 1. Demographic Profile of Cases No.

Percentage (%)

18-23

46

51.69

24-29

18

20.22

30-35

15

16.8

>35

10

11.23

0

54

60.67

1-2

27

30.34

Age (years)

Parity

3-4

5

5.62

>4

3

3.37

Residence Rural

68

76.4

Urban

21

23.6

Educated

18

20.22

Uneducated

71

79.77

Booked

12

13.48

Unbooked

77

86.52

Literacy

Booking status

Socioeconomic status

group of 18-23 years (51.685%) and primigravida (60.67%). Majority of the patients were unbooked, uneducated and belonged to rural background (Table 1). Maximum cases 57 (64.04%) presented with eclampsia, whereas 31 (34.83%) had severe preeclampsia (Table 2). Out of 57 cases of eclampsia, 44 (77.2%) had antepartum eclampsia followed by 11 (19.3%) cases who had postpartum eclampsia (Table 3).

It was observed that 51.72% of the cases had vaginal delivery, whereas 48.28% underwent lower segment cesarean section (LSCS) (Table 4). Various maternal complications were encountered; abruptio placenta was seen in 21 (23.6%), postpartum hemorrhage (PPH) in 12 (13.48%), pulmonary edema in 3 (3.37%), coagulopathy in 2 (2.25%), acute renal failure in 2 (2.25%) and HELLP (Hemolysis, Elevated Liver enzymes and Low Platelet count) syndrome in 5 (5.62%) (Table 5). Maternal mortality was 3.45%.

Table 2. Details of Hypertensive Disorders (n = 89) Hypertensive disorder

No.

Percentage (%)

Eclampsia

57

64.04

Pre-eclampsia

31

34.83

Chronic hypertension

1

31.25

Total

89

100

Table 3. Distribution of Cases According to Pattern of Eclampsia Pattern

No.

Percentage (%)

Antepartum

44

77.2

Intrapartum

2

3.5

Postpartum

11

19.3

Total

57

100

Table 4. Distribution of Cases According to Mode of Delivery Mode

No.

Percentage (%)

Lower

60

67.42

Vaginal delivery

45

51.72

Upper lower

15

16.86

Lower middle

10

11.24

LSCS

42

48.28

Upper middle

3

3.37

Total

87

100

Upper

1

1.12

N = 87 because one case got referred to higher center, while one case died before any intervention can be done.

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clinical study Table 5. Distribution of Cases According to Maternal Complications Maternal complications

No.

Percentage (%)

Abruptio placenta

21

23.6

Acute renal failure

2

2.25

Pulmonary edema

3

3.37

HELLP syndrome

5

5.62

Coagulopathy

2

2.25

PPH

12

13.48

Table 6. Fetal Outcome (n = 87) Outcome

No.

Preterm/Term (%)

Alive/Stillbirths (%)

50.58

66.67

49.42

33.33

Preterm (44) Alive

24

Stillbirth

20

Term (43) Alive

34

Stillbirth

9

Table 7. Complications as Reported by Different Authors Various researchers

Abruptio placenta (%)

Renal dysfunction (%)

Pulmonary edema (%)

HELLP syndrome (%)

Coagulopathy (%)

PPH (%)

Yücesoy et al12 (2005)

7.5

2.35

0.78

11

2.35

-

19

9

-

4.8

4.8

-

Liu et al10 (2008)

Shaheen et al (2008)

4.96

-

-

9.34

-

-

Present study

23.6

2.2

3.37

5.6

2.2

13.48

9

In the present study, 44 (50.58%) fetuses were preterm of which 24 were alive and 20 were stillbirths, followed by 43 (49.42%) which were term. Out of these 43 fetuses, 34 were alive while 9 were dead (Table 6). Fetal mortality was 33.33%.

Discussion There were 89 cases of hypertensive disorders in pregnancy, which presented as obstetric emergency during the period. Thus incidence came out to be 35.32%, which is similar to that seen in the study done

by Oladapo et al7 (2005). Present study had 60.67% hypertensive patients who were primigravida and 39.33% who were multigravida, which is almost similar to the study done by Tukur et al8 (2007), whereas Shaheen et al9 (2008), Liu et al10 (2008) and Kullima et al11 (2009) reported more prevalence in multigravida.

LSCS was done in 48.28% of cases which is almost similar to that seen in studies by Tukur et al8 (2007), 22

48.3% and Yücesoy et al12 (2005), 58.8%. Liu et al10 (2008) had high rates of LSCS (87.3%) due to fetal indications.

Present study had 23.6% abruption rates which is comparable to the study by Shaheen et al9 (2008), 19%, with some variations. Coagulopathy rates in the present study were similar to that seen in the study by Yücesoy et al12 (2005), 2.2% and 2.35%, respectively (Table 7).

Present study had 3.4% maternal mortality, which is almost similar to that reported by Yücesoy et al12 (2005), 1.17% and Shaheen et al9 (2008), 4.8%.

In the present study, 66.66% babies were born alive and 33.33% were stillbirths which is almost similar to the study by Shaheen et al9 (2008); 30% as abruption rates were high in both studies, 23.6% and 19%, respectively (Table 7). Tukur et al8 (2007) and Yücesoy et al12 (2005) had same rates of stillbirths 13% and 12.6%, respectively.

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

clinical study Conclusions From the present study, it is concluded that hypertensive disorders in pregnancy has a major role in maternal morbidity and mortality. Hypertensive disorders in pregnancy are more common in subjects who are unbooked, belong to low socioeconomic status and have poor access to antenatal care. Thus, there is a dire need of proper antenatal care, timely referral from periphery of high risk cases to prevent maternal morbidity and mortality.

References 1. James PR, Nelson-Piercy C. Management of hypertension before, during, and after pregnancy. Heart.

2004;90(12):1499-504.

2. Khan KS, Wojdyla D, Say L, Gülmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006;367(9516):1066-74.

5. Duley L. Pre-eclampsia and the hypertensive disorders of pregnancy. Br Med Bull. 2003;67:161-76.

6. World Health Organization. Coverage of maternity care.

A listing of available information. Geneva: Switzerland.

Maternal and Newborn Health/Safe Motherhood, 4th Edition; 1997.

7. Oladapo OT, Sule-Odu AO, Olatunji AO, Daniel OJ. “Near-miss” obstetric events and maternal deaths in Sagamu, Nigeria: a retrospective study. Reprod Health. 2005;2:9.

8. Tukur J, Umar BA, Rabi’u A. Pattern of eclampsia in a tertiary health facility situated in a semi-rural town in Northern Nigeria. Ann Afr Med. 2007;6(4):164-7.

9. Shaheen S, Tahir S. Management and outcome of severe pre-eclampsia. APMC. 2008;2(1):30-4.

10. Liu CM, Cheng PJ, Chang SD. Maternal complications and perinatal outcomes associated with gestational hypertension and severe preeclampsia in Taiwanese women. J Formos Med Assoc. 2008;107(2):129-38.

3. World Health Organization. The World Health Report 1998. Life in the 21st century: A Vision for All. Geneva: WHO; 1998. p. 97.

11. Kullima AA, Kawuwa MB, Audu BM, Usman H, Geidam AD. A 5-year review of maternal mortality associated with eclampsia in a tertiary institution in northern Nigeria. Ann Afr Med. 2009;8(2):81-4.

4. Bhide A, Arulkumaran S, Damania KR, Daftary SN. Hypertensive disorders in pregnancy (Chapter 13).

In: Arias’ Practical Guide to High-Risk Pregnancy and Delivery: A South Asian Perspective. 4th Edition, Haryana: Reed Elsevier India Private Limited; 2015. pp. 185-232.

12. Yücesoy G, Ozkan S, Bodur H, Tan T, Calişkan E, Vural B, et al. Maternal and perinatal outcome in pregnancies complicated with hypertensive disorder of pregnancy: a seven year experience of a tertiary care center.

Arch Gynecol Obstet. 2005;273(1):43-9.

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Case Report

Bilateral Single System Ectopic Ureters with Secondary Calculi in an Adult: Case Report Gopi Kishore M*, Suhasini G*, Prasad PVGS*, Sainadh AV*

Abstract Bilateral single system ectopic ureter (BSSEU) is a rare entity in urology presenting typically in the pediatric age group with urinary incontinence, recurrent urinary tract infection (UTI) or ureteric obstruction. It is generally agreed that these patients require ureteric reimplantation with or without bladder augmentation depending upon bladder capacity. We herein present a case of BSSEU presenting late in adulthood with secondary ureteric calculi, which is the first of its kind to be reported in literature.

It was managed endoscopically with satisfactory outcome and without a need for major reconstructive surgery.

Keywords: Ectopic ureter, secondary calculi, megaureter, hydroureteronephrosis

B

y definition, an ectopic ureter is any ureter, single or duplex, that does not enter the trigonal area of the bladder.1 It is more common among females and is usually associated with double collecting system. About one-fifth of ectopic ureters are associated with single system kidneys and are common in males. A rare entity of bilateral single-system ectopic ureters (BSSEU) occurs and may be associated with a hypoplastic bladder and bilateral renal abnormalities.2

hydroureteronephrosis with multiple calculi in right lower ureter and single calculus in left lower ureter.

Intravenous pyelogram (IVP, Fig. 2) revealed bilateral single system gross hydroureteronephrosis with multiple calculi in right ureter and one calculus in left ureter.

With provisional diagnosis of bilateral megaureters with secondary stones or bilateral lower ureteric calculi

We are presenting a case of BSSEU in an adult male with secondary stones, which was managed endoscopically.

Case Report A 50-year-old male presented with obstructive voiding symptoms, increased frequency, dysuria, hematuria and bilateral flank pain since 2 months. General examination was unremarkable. Abdominal examination was normal except mild bladder distension. External genitalia and per rectal examination was normal. All routine investigations including kidney function tests were normal.

Ultrasonography showed bilateral moderate hydroureteronephrosis with lower ureteric calculi.

Plain computed tomography-kidney, ureter and bladder (CT-KUB, Fig. 1) revealed bilateral *Dept. of Urology ESIC SSH, Sanath Nagar, Hyderabad, Telangana Address for correspondence Dr Gopi Kishore M Dept. of Urology, ESIC SSH, Sanath Nagar, Hyderabad - 500 038, Telangana E-mail: gkmeda@yahoo.com

24

Figure 1. Reformatted coronal image of plain CT-KUB scan showing bilateral hydroureteronephrosis with lower ureter calculi.

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

Case Report with megaureters, cystourethroscopy was carried out under spinal anesthesia. Cystourethroscopy (Fig. 3) showed right ureteric orifice just distal to bladder neck and left ureteric orifice distal to right ureteric orifice and 1 cm proximal to the veru with absent trigone and good capacity bladder. Bilateral retrograde pyelography showed bilateral single system ectopic megaureters with secondary calculi.

Definitive diagnosis of BSSEU with secondary calculi was made. Bilateral ureteric meatotomy was done up to 1 cm proximal to bladder neck using a Collins knife and stones fragmented with help of nephroscope and lithotripsy. As stone burden was high, fragmented stones in bladder were removed by percutaneous cystolithotripsy and bilateral double-J (DJ) stenting done. Postoperative recovery was uneventful. In postoperative period, the patient was totally continent and able to void freely. DJ stent was removed after 1 month and follow-up ultrasound showed decrease in hydroureteronephrosis and patient is doing well without urinary tract infection (UTI) or flank pain.

Discussion Ectopic ureters are more common in females, 80% of them drain a duplicated kidney and are frequently associated with a poorly functioning renal unit.3 Embryologically, ectopic ureters can arise due to abnormal timing or location of the primary ureteral budding from the mesonephric ducts.

That temporospatial location will determine both the character of the ureter incorporated into the emerging bladder, as well as the development of the trigone and kidney.2 It is believed that, as single system ectopic ureters (SSEU) are associated with dysplastic kidneys, the affected renal units do not function appreciably.3

Figure 2. Post-void IVP film showing bilateral single system hydroureteronephrosis with secondary calculi.

Right ureteric orifice

Left ureteric orifice

Veru

Figure 3. The cystourethroscopic picture showing both ureteric orifices in prostatic urethra.

Single system ureteral ectopia is due to cranial origin of ureteric bud from mesonephric duct, which results in delay in incorporation into the urogenital sinus and prevents in growth of mesenchyme, which is necessary for development of bladder neck musculature.4 As there is no formation of trigone and base plate, bladder neck is wide, poorly defined and incompetent.

BSSEUs are even rarer compared to SSEU.4 It is possible that during development the abnormal origin of both ureteric buds results in poor mesenchymal induction of the urogenital structures, which results in failure of normal development of the bladder nd bladder neck. Both the sphincter and reservoir functions of the bladder will be severely affected.

Overall, female patients are affected twice as commonly as males, although SSEU is reported to be more common in males.3,5 Usually, BSSEU present in infants or children with recurrent UTIs, urinary

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25

Case Report incontinence and a poor capacity of bladder, which requires ureteric reimplantation with or without bladder augmentation.6,7

presented in late adulthood with only obstructive symptoms, major reconstructive surgery was avoided and patient managed endoscopically.

In males, the posterior urethra is the most common site for insertion of the ectopic ureter.5,6 Evaluation is usually by ultrasonography, renal nuclear scan, micturating cystourethrography and retrograde pyelography. Intravenous pyelography and magnetic resonance imaging (MRI) may be used occasionally.2,6

References

Male patients with BSSEU in posterior urethra proximal to external sphincter may be continent with external sphincter control and have a good capacity bladder. Patients with good bladder capacity may require bilateral ureteric reimplantation alone.6,7 Our patient presented with obstructive symptoms due to stone in the right distal ureter obstructing bladder neck. As the patient presented in late adulthood with secondary stones and a good capacity bladder with normal continence, endoscopic management alone was done with ureteral meatotomy, lithotripsy and DJ stenting. Surgical management consisting of transurethral endoscopic incision of the distal ureter has previously been reported by Mathews et al.5 Ureteric reimplantation was not preferred as reflux in late age is not a worrying factor. However, the patient is kept on close follow-up for any late symptoms.

To the best of our knowledge, this is the first case of BSSEUs with secondary ureteric calculi presenting in adulthood in current English literature. As patient

1. Glassberg KI, Braren V, Duckett JW, Jacobs EC, King LR, Lebowitz RL, et al. Suggested terminology for duplex systems, ectopic ureters and ureteroceles. J Urol.

1984;132(6):1153-4.

2. Peters CA, Schlussel RN, Mendelsohn C. Ectopic ureter, ureterocele, and ureteral anomalies. In: Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA (Eds.). CampbellWalsh Urology. 10th Edition, Philadelphia: Saunders Elsevier; 2011. pp. 3236-66.

3. Keating MA. Ureteral duplication anomalies: ectopic ureters and ureteral anomalies. In: Belman BA, King LR, Kramer SA (Eds.). Clinical Pediatric Urology. 4th Edition, London: Martin Dunitz; 2002. pp. 677-733.

4. Redman JF, Lightfoot ML, Reddy PP. Bilateral single ureteral ectopia in a boy. Urology. 2002;60(3):514.

5. Mathews R, Jeffs RD, Maizels M, Palmer LS, Docimo SG. Single system ureteral ectopia in boys associated with bladder outlet obstruction. J Urol. 1999;161(4):1297-300.

6. Dange AS, Sen S, Zachariah N, Chacko J, Mammen KE. Single-system ureteral ectopia - Associated malformations and management in children lacking an orthotopic ureter.

Pediatr Surg Int. 1994;9:377-80.

7. Kumar A, Goyal NK, Trivedi S, Dwivedi US, Singh PB. Bilateral single system ectopic ureters: case report with literature review. Afr J Paediatr Surg. 2008;5(2):99-101.

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CASE REPORT

A Rare Case of Torsion Ovarian Fibroma Pradeep Musale Ramamchandra*, Lalitha Shivanna†, Mamatha Siddappaji‡

Abstract Ovarian fibroma is a benign solid tumor, which accounts for 1-4% of ovarian neoplasms. This is commonly seen in postmenopausal women. A 40-year-old para 3 live 3, who had undergone tubectomy and was having regular cycles, was admitted to our hospital with pain abdomen and a 16 weeks pelvic mass. Preoperatively, she was misdiagnosed as pedunculated fibroid with torsion.

On table, she was found to have ovarian fibroma with torsion. Total abdominal hysterectomy with bilateral salpingo-ovariotomy was done. Ovarian fibroma cannot be diagnosed accurately in preoperative period. Excision of tumor is the treatment of choice.

Keywords: Ovarian fibroma, postmenopausal women, pedunculated fibroid, torsion, abdominal hysterectomy, bilateral salpingo-ovariotomy

O

varian fibroma is a type of sex cord cell tumor of ovary. It is a solid tumor which accounts for 1-4% of benign ovarian tumors.1 This tumor commonly occurs in elderly patients, 80.9% were above 40 years and 40.9% were postmenopausal.2 Rarely, it is reported in young females as Gorlin syndrome (ovarian fibroma with nevoid basal cell carcinoma).3 Sometimes it is associated with ascites and pleural effusion, when it is known as Meigs’ syndrome. It is difficult to diagnose preoperatively; may be misdiagnosed as uterine myoma or if it is associated with ascites it may be mistaken for ovarian malignancy.

We are reporting one such case of ovarian fibroma operated with misdiagnosis of uterine myoma with torsion.

Case Report A 40-year-old para 3 live 3, who had undergone tubectomy and was having regular cycles, was admitted to Mandya Institute of Medical Sciences, Mandya, Karnataka with pain in the lower abdomen, on and *Assistant Professor † Professor and Head ‡ Obs-Gyne Specialist Dept. of Obstetrics and Gynecology Mandya Institute of Medical Sciences, Mandya, Karnataka Address for correspondence Dr Pradeep Musale Ramamchandra Assistant Professor Dept. of Obstetrics and Gynecology Mandya Institute of Medical Sciences, Mandya - 571 401, Karnataka E-mail: majormrp@gmail.com

off, since 1 week and which became more severe since past 2 days. Patient was conscious and oriented, afebrile, pallor was present, pulse - 94 beats/min and blood pressure (BP) - 100/70 mmHg. On abdominal examination, a firm and irregular pelvic mass of 16 weeks size was palpable per abdomen.

Bimanual examination revealed a pelvic mass of 16-18 weeks, irregular in shape, firm in consistency and tender. Other systemic examinations were normal.

Ultrasound pelvis showed a normal-sized uterus with solid mass of 12 × 9.0 × 8.0 cm? Pedunculated fibroid; right side ovary was not seen and left ovary showed a small cyst of 3 cm. Urine pregnancy test was negative, chest X-ray was normal, USG abdomen was normal with no ascites.

Preoperatively a diagnosis of a pedunculated subserous fibroid with torsion/ovarian cyst with torsion was made. Her hemoglobin (Hb) was 8.2 g/dL and since pain was increasing after admission she was planned for emergency laparotomy.

Peroperatively, uterus of parous size with a rightsided solid ovarian mass of 15 × 10 × 10 cm was seen with torsion three times around itself, and appeared inflamed. There was no ascites (Fig. 1 a and b).

Left ovary revealed a cyst of 3 × 3 cm size; total abdominal hysterectomy with bilateral salpingoovariotomy was done. Postoperative period was uneventful and the patient was discharged on 7th postoperative day.

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27

Case Report imaging (MRI) is an excellent modality for detection of ovarian fibroma as they enhance less than myometrium and fibroids.6 In rare cases, carcinoembryonic antigen-125 may be raised.7 But ovarian fibroma is a benign tumor with extremely low malignant potential. It may be misdiagnosed as uterine fibroma, torsion ovarian cyst, ectopic pregnancy and ovarian malignancy.

Development of ascites is attributed to inefficient lymphatic drainage through small-sized pedicle and lack of real tumor capsule to the tumor and hydrothorax is secondary to ascites due to transdiaphragmatic passage.8

a

b

Figure 1 a and b. Torsion of ovarian fibroma with fallopian tube and uterus.

Treatment is excision of tumor by open or laparoscopic surgery, and life expectancy is same as in general population. Laparoscopy can be a diagnostic tool in detection of tumor and for resection of tumor or for ovariotomy. It can be converted into laparotomy in malignant cases.2 Complete resolution of ascites and pleural effusion takes place after surgery. In young patients with Gorlin syndrome, ovarian preservation can be done by resecting only fibroma.3 Conclusion

Figure 2. Microscopic appearance of ovarian fibroma showing spindle cells.

Histopathology report shows single grey-brown mass 14 Ă&#x2014; 12 Ă&#x2014; 10 cm cut section shows solid grey-brown to dark-brown hemorrhagic areas. Microscopy section from ovarian mass showed features of fibroma with hemorrhage consistent with torsion (Fig. 2).

Discussion Ovarian fibromas account for 1-4% of ovarian neoplasms; 10-15% of these are associated with ascites and 1% have both ascites and pleural effusion.4 Ovarian fibromas are seen in middle-aged women, largely asymptomatic unless they undergo torsion.

They are solid ovarian tumors and they are benign, so detection of fibroma is important to decrease patient anxiety and unnecessary extensive surgical procedure.

Ovarian fibromas cannot be diagnosed accurately either clinically or by ultrasound.5 Magnetic resonance 28

Ovarian fibromas are benign tumors accounting for 1-4% of ovarian neoplasms, seen in elderly patients, generally asymptomatic and cannot be diagnosed accurately preoperatively; excision of tumor is the choice of treatment.

References 1. Chechia A, Attia L, Temime RB, Makhlouf T, Koubaa A. Incidence, clinical analysis, and management of ovarian fibromas and fibrothecomas. Am J Obstet Gynecol.

2008;199(5):473.e1-4.

2. Son CE, Choi JS, Lee JH, Jeon SW, Hong JH, Bae JW. Laparoscopic surgical management and clinical characteristics of ovarian fibromas. JSLS. 2011;15(1): 16-20.

3. Ball A, Wenning J, Van Eyk N. Ovarian fibromas in pediatric patients with basal cell nevus (Gorlin) syndrome.

J Pediatr Adolesc Gynecol. 2011;24(1):e5-7.

4. Abad A, Cazorla E, Ruiz F, Aznar I, Asins E, Llixiona J. Meigsâ&#x20AC;&#x2122; syndrome with elevated CA125: case report and review of the literature. Eur J Obstet Gynecol Reprod Biol.

1999;82(1):97-9.

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

Case Report 5. Najmi Z, Mehdizadehkashi A, Kadivar M, Tamannaie Z, Chaichian S. Laparoscopic approach to a large ovarian fibroma: a case report. J Reprod Infertil. 2014;15(1): 57-60.

6. Shinagare AB, Meylaerts LJ, Laury AR, Mortele KJ. MRI features of ovarian fibroma and fibrothecoma with histopathologic correlation. AJR Am J Roentgenol.

2012;198(3):W296-303.

7. Morán-Mendoza A, Alvarado-Luna G, Calderillo-Ruiz G, Serrano-Olvera A, López-Graniel CM, Gallardo-Rincón D. Elevated CA125 level associated with Meigs’ syndrome: case report and review of the literature. Int J Gynecol Cancer.

2006;16 Suppl 1:315-8.

8. Nigam A, Jain S, Lal P. Twisted ovarian fibroma mimicking as an ectopic pregnancy. J Case Rep. 2013;3:64-7.

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29

MEDICOLEGAL

Case of Mix-up or Switching of Gametes, Embryos – Glaring Omission Under ART Bill, India Sonali Kusum

Abstract Infertility has been recognized as an alarming public health issue worldwide with estimated 48.5 million infertile globally and over 20 million infertile couples in India.1 In the background of rising infertility, couples around the world are resorting to assisted reproductive technologies (ART) including in vitro fertilization, surrogacy to attainment of parenthood ensuring child either genetically related with either or both couples or otherwise. However, in many cases, there has been gross errors in handling gametes, embryos by clinics or banks, leading to breach of medical ethics, violation of right to privacy, family formation of couples of patients, legal complexities. The objective of this paper was to identify such grave medical malpractices by the fertility clinics or banks, to emphasize on the unregulated, unmonitored functioning of such clinics in the absence of law and to demonstrate implicit biomedical legal issues through case studies. As a proposed conclusion to suggest for formulation of progressive, effective biomedical ethical standards to be complied by the clinics, banks for providing better reproductive healthcare and to suggest inclusion of the same in the proposed law. For the same, there was use of comparative legal perspectives, descriptive or analytical research methods following literature survey, relying on primary and secondary sources of data collection. There was use of comparative legal perspectives, descriptive research methods following literature survey, secondary data sources.

Keywords: Biomedical ethical safeguards, in vitro fertilization mix-up, surrogacy law, regulations India, switching gametes or embryos

U

nderstanding the cases of in vitro fertilization (IVF) mix-up or switching of gametes or embryos or misdirection of gametes are identified as “medical errors” which may occur or take place during the course of practice of assisted reproductive technology (ART), which essentially/ inherently involves handling of human biological materials or gametes or embryos through the retrieval, processing, transfer and storage of human gametes and embryos. These medical errors may include use of wrong sperm for insemination, or mistakenly switched gametes or embryos resulting in fertilization, or any other manipulation during embryo transfer, implantation or use of the gametes or embryos in implantation not those originally intended for use in the patient undergoing treatment, potentially leading

Research Scholar National Law School of India University, Bangalore, Karnataka Ex-Assistant Professor Tata Institute of Social Sciences, Mumbai, Maharashtra Address for correspondence Dr Sonali Kusum Room No. 105, Narmada Girls Hostel National Law School of India University, Nagarbhavi, Bangalore - 560 072, Karnataka E-mail: sonali.lipi@gmail.com

30

to the birth of a child with a different genetic parentage than intended, or an unplanned genetic parentage causing negative consequences or harm for patients.

These medical errors are subsequently discovered through DNA tests during the course of civil, legal formalities when the couple or the patient is seeking to apply for citizenship, passport or birth registration for the concerned surrogate child.

While the Assisted Reproductive Technologies (ART) Bill 20142 is awaiting to be enacted, given effect, there are glaring commissions and unresolved issues under the proposed ART Bill 2014. A major lacuna under the Bill is the absence of provisions to address cases of mix-up or switching of gametes. Though under the relevant provisions of the Bill, there is statutory duties imposed on ART Banks “to follow highest possible standards for storage and handling of gametes and human embryos”,3 but there is no legal recourse or remedial measure under the Bill in case of failure to perform such duty by ART Banks. There have been series of such cases of mix-up or switching of gametes both nationally and internationally, while gametes are stored with the ART Bank for various reasons including deferred use; these occurrences impair cardinal human rights established under constitution as well as human

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

MEDICOLEGAL rights conventions including right to privacy, family formation, right to procreative or reproductive health thereby constituting breach of right to life, which leave the couples legally vulnerable without any legal remedy under such circumstances. Some of these cases are quoted as below: i. Canadian Intending couple mix-up of gametes at ART Bank in India, 2005 yr.4– zz A Toronto-based couple commissioned surrogacy

in India in 2005 by availing the gestational services of an Indian surrogate mother who was carrying a fetus conceived of eggs from anonymous egg donor and intending father’s sperm resulting in birth of surrogate twins boy and surrogate girl in March 2006.

The couple applied for citizenship to the Canadian High Commission in New Delhi by adducing proof of genetic connection between the couple and the surrogate child using DNA test that showed the boy was not genetically related, only girl child was genetically connected, this indicated an error or mixup or switch or swapping of gametes in the Indian fertility lab. The Canadian Government permitted citizenship only for the genetically related twin girl but refused to issue citizenship to the other twin, leaving the couple stranded in India. The couple made an application on humanitarian and compassionate grounds for their nonbiological child to be granted citizenship, the Canadian Government issued a citizenship card and travel papers to the other twin only in the year 2012, almost 6 years after the couple commissioned surrogacy in India.

ii. Dr KK Gopinathan vs. Anitha Jayadevan5 - Kerala couple mix-up of gametes at Clinic in Kerala, 2012 yr.– zz A Kerala-based couple named Mr and Mrs Anitha

Jayadevan underwent intracytoplasmic sperm injection (ICSI) treatment using their own gametes, the sperm of her husband, her own ovum, respectively.

Following a DNA test, it was found that there was no genetic connection with the intending mother and the fetus. The hospital authorities admitted a donor ovum was used for artificial insemination. The couple has filed a law suit in the High Court of Kerala against the Hospital authorities for ` 20,01,000 as damages. Ms Anitha has written a book titled as “Malicious medicine: my experience with fraud and falsehood in infertility clinics” (Malayalam language) on her testimony and recounting similar cases of mix-up and switching of

gametes by infertility clinics among other misuse and malpractice of technology by clinics. iii. Baby X - New Zealand – mix-up, swapping of child post birth, 2015 yr.6– zz A New Zealand couple, Mr and Mrs Y, commissioned

surrogacy in Chiang Mai Thailand using intending father’s sperm, egg donor from a family member and a local Thai woman to act as surrogate mother to carrying the same resulting in birth of baby X in Thailand. The couple applied for issue of travel documents for the surrogate child in compliance with the New Zealand Immigration Rules.

A DNA test, was conducted that showed that the surrogate child had no genetic connection with the father, or the relative who donated the egg or to the surrogate. This indicated embryos were mixed-up during IVF or the baby was swapped after birth. New Zealand Family Court Judge held that “Baby X was not the child the concerned intended parents, this is another child altogether.” The couples were directed by the authorities to leave the Baby X surrogate child in a Thai orphanage. The Baby X was born with no genetic records, no identity even termed as “scrap of humanity”, investigation into the identification of the genetic parents of Baby X, showed nil records with the hospital authorities on the same. However, the couple sought to adopt the Baby X following the foreign adoption orders. This case manifest the legal, human crisis underlying such issues, gross violation of right to life of child.

iv. A White couple had black twins following mix-up of gametes, UK, 2001 yr.7– zz UK-based White couple, named Mr and Mrs A, had black

twins following an IVF mix-up at the ART Clinic owing to confusion over sperm, eggs or embryos belonging to a Black couple with those from a White couple.

Findings and Inferences Progressive regulations on handling of gametes, embryos - A comparative foreign legal perspective: In the light of these cases, it is imperative to consider comparative foreign laws, regulations on the same.

The UK Human Fertilization and Embryology Authority (HFEA)8 provides for code of practice for effective monitoring system of to ensure security, storing, handling of gametes and embryos. The UK HFEA Guidance Note was issued to all clinics

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MEDICOLEGAL centers with the main purpose to minimize, check use of wrong gametes or IVF mix-up cases, wrong infertility treatments. The UK HFEA recommends to the clinics and centers to ensure, maintain highest possible standards including effective monitoring for storage and handling of gametes and embryos. These guidelines are laid down as below:9 zz

All clinics handling, using of stored or donated gametes or biological materials are to be licensed by the HFEA.

zz

Periodic inspection of gametes, embryos or biological materials kept at the clinic by the Clinical and Scientific Inspectors. The UK HFEA also regularly inspects and monitors the same.

zz

zz

Double-check identification of the individuals undergoing treatment, the sperm and eggs at the time of insemination, and the embryos and the patient at the time of embryo transferred.

Confirmation by the nurse, the embryologist and the gynecologist establishing patient’s identity.

zz

The source of gametes and embryos should be accurately recorded and labeled in a manner that is not susceptible to unauthorized or undetectable alteration.

zz

The location of gametes and embryos in such a manner to minimize unnecessary handlings, interventions in retrieving the same.

zz

Labeling with unique identification of an individual’s all biological material including gametes, embryos at all stages of treatment.

Writing the names of the patients on both the lid and the bottom of the dish.

zz

zz

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Procedures for ‘cross-identification’ or doublechecking the identification of gametes embryos at three crucial stages namely the individuals undergoing treatment, the sperm and eggs at the time of insemination, the embryos and the patient at the time of embryo transfer.

Restricted Permissible access to such gametes, embryos only to such concerned or named Person in the center, for whom it is essential to their work.

No Permission for any other person to access to gametes and embryos.

Maintenance of records on the location of gametes and embryos along with each occasion of handling

of gametes or embryos, source of gametes and embryos, the various procedures or recourse on embryo, egg or sperm sample collected kept from the date of collection.

The European Society of Human Reproduction and Embryology (ESHRE) - Handling and Identification of patients and their gametes and embryos:10 zz

Training of all the laboratory staff on handling of gametes, embryos is made mandatory.

zz

Development of written procedures describing the various phases or stages of handling of IVF techniques.

zz

All biological materials including gametes, embryos obtained from the patients should bear unique identification of the treated couple.

zz

Organization of incubators in such a manner so as to facilitate better identification of gametes and embryos.

zz

Double checks of patients and their gametes and embryos must be maintained, recorded at these stages: Insemination of oocytes, replacement of embryos, embryo freezing and thawing, respectively.

zz

Verification of patient’s identity should be performed at crucial stages such as at ovum retrieval, at semen recovery and embryo transfer procedures.

The American Society for Reproductive Medicine (ASRM)11 - Ethical Committee on Disclosure of medical errors involving gametes and embryos: zz

The ASRM imposes stringent ethical obligation on the Clinics to disclose errors at the earliest as soon as discovered without any further delay.

zz

To respect patient autonomy and practice fairness in treatment, delivery of services to patients.

zz

To uphold and recognize the patient’s right to know is compelling in case of such misdirection or medical error of mix-up or switching of gametes or embryos. Physicians are obligated to disclose to patients any error as soon as discovered that could lead to a child being born with an unintended paternity or maternity.

zz

Clinics are obliged to ensure availability of necessary written policies and procedures for making disclosure of errors to patients in such cases without nay exception.

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

MEDICOLEGAL Preventive safeguards for the couples12 - to detect genetic connection of the child with the intended parents with the child during pregnancy.

Preimplantation Genetics Diagnosis (PGD): This genetic test intended for identifying genetic defects in embryos; this test carried out before implantation ensures a couple that the embryo shares the genetic match with the intended couples.

Amniocentesis: This is another prenatal test using amniotic fluid around the fetus for detection of chromosomal and genetic birth defects and identifies genetic match with the intended couples.

Such early identification or determination allows the couples in consultation with clinic to decide on the continuation or termination of pregnancy or fetal reduction or otherwise. Thus, safely prevents any further IVF mix-up or birth of child with unintended genetic parentage.

Issues for Consideration These cases raise a range of issues as enumerated, first and foremost these cases evince the large scale malpractice, abuse of this technology by ART Clinics, Banks. These clinics, banks as well as unregulated, unmonitored practice of these clinics, banks which are largely unregistered, lack infrastructure, expertise and function for vested or commercial gains flouting the Indian Council of Medical Research (ICMR) guidelines as these are nonbinding. Similar concerns are expressed by the ICMR, which have reported that there are some 1,200 ART Clinics in India. Only 177 of these, have enrolled with the ICMR. â&#x20AC;&#x153;While some have top-class facilities, others are really bad in terms of infrastructure and technical expertise.â&#x20AC;? Under these circumstances, with no effective law, any accountability, control or check on the functioning of these clinics is challenging.

In addition to this, there are other pertinent concerns associated with the same, which are briefly mentioned as follows: zz There is need for inclusion of biomedical ethical principles, safeguards coupled with protocols, best practices to prevent ensure maximum safety, minimize any tampering, manipulation and check or control of such acts. zz There must be identification of onus of proof, legal presumption establishing the liability for such acts

commission or omissions or any foul play on the part of ART Bank, Clinic. zz Legal recourse or remedial measure may be provided to redress such cases including complaint forum, procedural mechanism for the same. zz To specifically enlist the acts of mix-up switching, swapping of gametes, embryos as punishable act with imprisonment, fine under the list of offences as ART Bill 2014.

Conclusion These issue gain alarming significance in the absence of a binding legislation in India. These unresolved issues were submitted for consideration of law and policy makers formulating the ART Bill 2014. A list of select provisions taken after the regulations, best practices of international medical regulatory bodies for safe, desirable practice of ART technology was suggested that may be incorporate under the ART Bill as there was omission to address the same in the face of rising number of such irregularities and legal complexities.

There should be inclusion of mandatory principles of biomedical ethics in the Bill seeking compliance from all banks, clinics towards ensuring safe practice of ART technology in the best interest of couples as well as towards greater good of society.

References 1. Venkat V. There are 20 million infertile couples in India.

The Hindu, September 28, 2014. Available at: http://www. thehindu.com/sunday-anchor/pushpa-m-bhargava-thereare-20-million-infertile-couples-in-india/article6453374. ece. See also, Agarwal A, Mulgund A, Hamada A, Chyatte MR. A unique view on male infertility around the globe.

Reprod Biol Endocrinol. 2015;13:37.

2. Government of India, Ministry of Health and Family Welfare (Department of Health Research) ART Bill 2014, 30th September 2015. Available at: http://www. prsindia.org/uploads/media/draft/Draft%20Assisted%20 Reproductive%20Technology%20(Regulation)%20 Bill,%202014.pdf.

3. ART Bill 2014 Sec. 53. (1) The highest possible standards should be followed in the storage and handling of gametes and human embryos in respect of their security, and with regard to their recording and identification.

4. Aulakh R. Couple fights federal surrogacy policy to bring their boy back to Canada. The Satr. Aug 20, 2011. Available at: http://www.thestar.com/news/gta/2011/08/20/couple_

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MEDICOLEGAL of gametes and embryos Storage of gametes and embryos.

Available at: http://www.hfea.gov.uk/505.html (Last visited March 1, 2016). See also, UK Gov. Human Fertilization and Embryology Authority, UK HFEA, Press releases archive 2002, HFEA statement on the systems currently in place to prevent use of the ‘wrong’ infertility treatment.

11 September 2002. Available at: http://www.hfea.gov. uk/925.html.

fights_federal_surrogacy_policy_to_bring_their_boy_ back_to_canada.html.

5. OP(C).No. 2084 of 2012 (O), OS.12/2004 of Sub Court, Tirur. Available at: http://indiankanoon.org/doc/57268181/ (Last visited March 1, 2016). See also, Tehelka. The invisible baby makers. Issue 50 Volume 11, 2014-12-13. Available at: http://www.tehelka.com/2014/12/the-invisible-babymakers/.

6. Woulfe C. The untold story of NZ’s surrogate babies. New Zealand Listner Current Affairs, Science. Available at: http://www.listener.co.nz/current-affairs/the-untold-storyof-nzs-surrogate-babies/ (Last visited March 1, 2016). See also, Penfold P. Breakthrough in surrogacy mix-up case.

Newshub 30 Nov 2015. Available at: http://www.newshub. co.nz/tvshows/3d/breakthrough-in-surrogacy-mix-up-case2015113017#ixzz44HpYYOiD. 7. Morris S. Clinics urged to tighten checks after embryo mix-up. The Guardian. July 9, 2002. Available at: http://www.theguardian.com/uk/2002/jul/09/health. healthandwellbeing.

8. UK Gov. Human Fertilization and Embryology Authority.

Available at: http://www.hfea.gov.uk/25.html.

9. UK Gov. Human Fertilization and Embryology Authority, UK HFEA, Code of Practice, Guidance notes No. 17, Use

10. Gianaroli L, Plachot M, van Kooij R, Al-Hasani S, Dawson K, DeVos A, et al. ESHRE guidelines for good practice in IVF laboratories. Committee of the Special Interest Group on Embryology of the European Society of Human Reproduction and Embryology. Hum Reprod.

2000;15(10):2241-6.

11. American Society for Reproductive Medicine, American Society for Reproductive Medicine (ASRM). Disclosure of medical errors involving gametes and embryos: an Ethics Committee opinion. Elsevier Inc., 2015. Available at: https://www.asrm.org/uploadedFiles/ASRM_Content/ News_and_Publications/Ethics_Committee_Reports_ and_Statements/disclose_errors.pdf 12. Katherine, IVF Mistakes: Making Sure the Baby Is Yours.

March 26, 2007. Available at: http://www.foxnews.com/ story/2007/03/26/ivf-mistakes-making-sure-baby-is-yours. html.

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Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

AROUND THE GLOBE

News and Views

Use of Augmented Reality in Laparoscopic Gynecology to Visualize Myomas The goal of a recent study published in the Fertility and Sterility was to report the use of augmented reality (AR) in gynecology and demonstrate the use of a new AR approach specifically for uterine surgeries, in myomectomy. AR is a surgical guidance technology that enables hidden surface structures to be visualized in endoscopic images. This experimental study included three patients diagnosed with one, two, and multiple myomas, respectively, in whom AR was used to localize myomas. In this study, three-dimensional (3D) models of the patientsâ&#x20AC;&#x2122; uterus and myomas, constructed before their surgeries, were automatically aligned and "fused" with the laparoscopic video in real time. It was observed that the live fused video made the uterus appear semitransparent, and the surgeon could visualize the location of the myoma in real time. This improved a surgeonâ&#x20AC;&#x2122;s access and decision making while approaching a myoma.

Hence the AR system developed for gynecological surgery was found to improve the laparoscopic myomectomy procedure. It was also confirmed that the developed software facilitated additional useful features, such as image blur, fast motion, and partial views of the organ.

Obstetrics and Gynecology Residency and Fertility Needs A recent study published in the Reproductive Sciences aimed at understanding the prevalence of fertility and the utilization of infertility services among the obstetrics and gynecology (Ob/Gyn) residents.

In this study, a cross-sectional descriptive survey was conducted on 241 respondents distributed among US Accreditation Council for Graduate Medical Education-accredited Ob/Gyn programs.

The participants comprised of an equal number of junior and senior residents. It was found that 85% of the respondents did not choose fertility during their residency. 29% opted for fertility preservation with

only 2% approaching a consultation. Additionally, 63% of the participants did not consider the program to be supportive and 35% reported stigma against infertility. It was inferred that infertility is a prevalent reproductive health issue among Ob/Gyn residents. It was found that a majority of residents defer childbearing during residency irrespective of their age. Most of the residents acknowledged little or no support from training programs in addressing their fertility care.

Misoprostol â&#x20AC;&#x201C; For Early Pregnancy Loss A new study published in Human Reproduction assessed the success rate of early pregnancy loss with repeated administration of Misoprostol. A total of 87 participants were administered a single dose while 84 participants were given repeated doses of the drug.

It was observed that 77% of patients in the single-dose group successfully lost their pregnancies, whereas the treatment showed a success rate of 76% in the repeatdose group. Additionally, patients of the repeateddose group reported requiring more analgesics.

Thus, the single-dose method of treatment was considered superior in comparison.

Effect of Angiotensin-(1-7) in Human Follicular Fluid on Oocyte Maturation A recent study published in Human Reproduction showed the relationship between angiotensin (Ang)-(1-7) levels and the proportion of mature oocytes in humans. This study was conducted on 64 participants from an in vitro fertilization centre, during 6 subsequent months. It was observed that there was a considerable rise in plasma Ang-(1-7) after the induction of ovulation. However, follicular fluid could not be correlated to Ang-(1-7) levels.

Furthermore, luteinized granulosa cells were detected with Mas receptor mRNA which could be linked to the number of mature oocytes. Ang-(1-7) is found to promote maturation of oocyte in other species, hence it was proposed that further study would be required to confirm a similar effect in humans.

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Asian

Journal of

OBSTETRICS & GYNAECOLOGY Practice

Information for Authors

Manuscripts should be prepared in accordance with the ‘Uniform requirements for manuscripts submitted to biomedical journals’ compiled by the International Committee of Medical Journal Editors (Ann. Intern. Med. 1992;96: 766-767).

Asian Journal of Obstetrics and Gynaecology Practice strongly disapproves of the submission of the same articles simultaneously to different journals for consideration as well as duplicate publication and will decline to accept fresh manuscripts submitted by authors who have done so.

The boxed checklist will help authors in preparing their manuscript according to our requirements. Improperly prepared manuscripts may be returned to the author without review. The checklist should accompany each manuscript.

Authors may provide on the checklist, the names and addresses of experts from Asia and from other parts of the World who, in the authors’ opinion, are best qualified to review the paper.

Covering letter -

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The covering letter should explain if there is any deviation from the standard IMRAD format (Introduction, Methods, Results and Discussion) and should outline the importance of the paper.

Principal/Senior author must sign the covering letter indicating full responsibility for the paper submitted, preferably with signatures of all the authors.

Articles must be accompanied by a declaration by all authors stating that the article has not been published in any other Journal/Book. Authors should mentioned complete designation and departments, etc. on the manuscript.

Manuscript - Three complete sets of the manuscript should be submitted and preferably with a CD; typed double spaced throughout (including references, tables and legends to figures).

- The manuscript should be arranged as follow: Covering letter, Checklist, Title page, Abstract, Keywords (for indexing, if required), Introduction, Methods, Results, Discussion, References, Tables, Legends to Figures and Figures.

- All pages should be numbered consecutively beginning with the title page.

Note: Please keep a copy of your manuscript as we are not responsible for its loss in the mail. Manuscripts will not be returned to authors.

Title page Should contain the title, short title, names of all the authors (without degrees or diplomas), names and full location of the departments and institutions where the work was performed, name of the corresponding authors, acknowledgment of financial support and abbreviations used.

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The title should be of no more than 80 characters and should represent the major theme of the manuscript.

A subtitle can be added if necessary.

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A short title of not more than 50 characters (including inter-word spaces) for use as a running head should be included.

- The name, telephone and fax numbers, e-mail and postal addresses of the author to whom communications are to be sent should be typed in the lower right corner of the title page.

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A list of abbreviations used in the paper should be included. In general, the use of abbreviations is discouraged unless they are essential for improving the readability of the text.

Summary - The summary of not more than 200 words. It must convey the essential features of the paper.

- It should not contain abbreviations, footnotes or references.

Introduction - The introduction should state why the study was carried out and what were its specific aims/objectives.

Methods - These should be described in sufficient detail to permit evaluation and duplication of the work by others.

- Ethical guidelines followed by the investigations should be described.

Statistics The following information should be given: - The statistical universe i.e., the population from which the sample for the study is selected.

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Method of selecting the sample (cases, subjects, etc. from the statistical universe).

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Method of allocating the subjects into different groups.

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Statistical methods used for presentation and analysis of data i.e., in terms of mean and standard deviation values or percentages and statistical tests such as Student’s ‘t’ test, Chi-square test and analysis of variance or non-parametric tests and multivariate techniques.

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Confidence intervals for the measurements should be provided wherever appropriate.

Results -

These should be concise and include only the tables and figures necessary to enhance the understanding of the text.

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Discussion -

This should consist of a review of the literature and relate the major findings of the article to other publications on the subject. The particular relevance of the results to healthcare in India should be stressed, e.g. practicality and cost.

References These should conform to the Vancouver style. References should be numbered in the order in which they appear in the texts and these numbers should be inserted above the lines on each occasion the author is cited (Sinha12 confirmed other reports13,14...). References cited only in tables or in legends to figures should be numbered in the text of the particular table or illustration. Include among the references papers accepted but not yet published; designate the journal and add ‘in press’ (in parentheses). Information from manuscripts submitted but not yet accepted should be cited in the text as ‘unpublished observations’ (in parentheses).

At the end of the article the full list of references should include the names of all authors if there are fewer than seven or if there are more, the first six followed by et al., the full title of the journal article or book chapters; the title of journals abbreviated according to the style of the Index Medicus and the first and final page numbers of the article or chapter. The authors should check that the references are accurate. If they are not this may result in the rejection of an otherwise adequate contribution.

Examples of common forms of references are:

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Illustrations must be drawn neatly by an artist and photographs must be sent on glossy paper. No captions should be written directly on the photographs or illustration. Legends to all photographs and illustrations should be typed on a separate sheet of paper. All illustrations and figures must be referred to in the text and abbreviated as ‘Fig.’.

Please complete the following checklist and attach to the manuscript: 1. Classification (e.g. original article, review, selected summary, etc.)_______________________________

Articles

2. Total number of pages ________________________

Paintal AS. Impulses in vagal afferent fibres from specific pulmonary deflation receptors. The response of those receptors to phenylguanide, potato S-hydroxytryptamine and their role in respiratory and cardiovascular reflexes.

Q. J. Expt. Physiol. 1955;40:89-111.

3. Number of tables ____________________________

Books

Indian 1.____________Foreign 1.________________

Stansfield AG. Lymph Node Biopsy Interpretation Churchill Livingstone, New York 1985.

2.____________ 2.________________

3.____________ 3.________________

Articles in Books

4.____________ 4.________________

Strong MS. Recurrent respiratory papillomatosis. In: Scott Brown’s Otolaryngology. Paediatric Otolaryngology Evans JNG (Ed.), Butterworths, London 1987;6:466-470.

7. All authors’ signatures________________________ 8.

Corresponding author’s name, current postal and e-mail address and telephone and fax numbers __________________________________________

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Online Submission Also e-issue @ www.ijcpgroup.com For Editorial Correspondence

Dr KK Aggarwal

Group Editor-in-Chief Asian Journal of Obstetrics and Gynaecology Practice E - 219, Greater Kailash, Part - 1, New Delhi - 110 048. Phone: 011-40587513 E-mail: editorial@ijcp.com, Website: www.ijcpgroup.com

Asian Journal of Obstetrics and Gynaecology Practice, Vol. 1, No. 1, January-March 2017

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