WORLD OF WOMEN 7
Fertility Pregnancy Health
03
What’s Inside What’s New Page 4 Impact of COVID-19 on pregnancy and breastfed infants
Page 8
Human pregnancy is weird
New research adds to the mystery
Page 7
FERTILITY SUPERHERO RECOMBINANT FOLLITROPIN ALFA R-HU FSH
weird and wonderful fertility superstitions
Page 18
04 What’s New Impact of COVID-19 on pregnancy and breastfed infants https://www.newsmedical.net/news/20200504/Impactof COVID19onpregnancyandbreastfedinfants.aspx
Modalities
Intro Pregnant women are among those at high risk of developing COVID-19, as confirmed in Wuhan early in the pandemic. A new study from Portugal published on the preprint server medRxiv* in May 2020 analyses the data on the impact of COVID-19 on pregnancy and disease outcomes, using published cases of pregnant women diagnosed with the illness. COVID-19 can occur at any age, but infections in children make up less than 1% of the total.
The research team searched PubMed, a medical research database, to find original published studies on pregnant women. They were diagnosed with COVID19 at any stage of their pregnancy, at any date and in all languages up to April 8, 2020. Researchers did not exclude any papers based on the assumed quality of the study. All Portuguese cases were verified, and information was collected from their health professionals. In total, 30 original studies concerning 212 pregnant women with COVID19 were chosen for the study. Of these, 200 were from China and 12 from other countries. Among these, 30 were discharged during pregnancy. The ages ranged from 22 to 41. Most women were in the third trimester of pregnancy.
05 "There is no evidence that the risk of infection with COVID-19 in pregnant women is greater than in the general population. However, the incidence of infection in pregnant women is unknown, as screening tests were not generally used, except in the presence of symptoms," the researchers said.
"It is essential to prevent the infection of COVID-19 and any other viral respiratory infection, as these infections represent an increased risk for the pregnant woman and for the pregnancy itself," researchers said, advising pregnant women to take preventive action to avoid contracting the virus.
Study Results There were 182 published deliveries with four twin pregnancies, resulting in one stillbirth and 185 live births. Most of the deliveries were by Cesarean section. Four of the women with severe symptoms required intensive care, but there were no cases of maternal death. Nearly 30 percent of cases were preterm births; however, the researchers stated that there was insufficient evidence to link these to COVID19. Only one neonatal death was reported. All the cases in which amniotic fluid, placenta or cord blood was analyzed for severe acute respiratory syndrome coronavirus 2 (SARSCoV2) reported that
"The decision on the type of delivery in pregnant women with suspected or confirmed infection with COVID-19 should take into account the maternal and fetal clinical characteristics, as is normal practice, and not the diagnosis of COVID-19 infection per se," the paper said.
the samples tested negative. Breast milk samples from 13 mothers described in seven studies showed no evidence for the presence of SARSCoV2. However, four newborns in China were positive for SARS CoV2 in nasopharyngeal and anal swabs collected on the second and fourth days after delivery, constituting about 2.2 percent of the study. In another study reporting six babies, with blood tests after delivery, three of them had high levels of IgM antibodies, and three had high IgG levels. Similar case studies have been described in other papers, but none of these have isolated the virus itself.
"Considering the benefits of breastfeeding and the fact that the transmission of other respiratory viruses is insignificant through breast milk, there is no indication to stop breastfeeding," researchers said.
06 What’s New 77
For PCOS Women with Polycystic Ovary Syndrome (PCOS) should consider adopting a mindful yoga practice to help ease symptoms and improve androgen levels. Researchers found a onehour mindful yoga class, done three times a week, reduced testosterone levels by 29% over a threemonth period. Other androgen levels, like DHEA, were also reduced, and depression and anxiety levels improved by 55% and 21%, respectively, according to the study in The Journal of the American Osteopathic Association. Reducing androgen levels, including testosterone and DHEA, is key to managing these symptoms. Weight loss, where appropriate, can also help in the management of symptoms. Researchers recruited women with PCOS aged 2243 and randomly assigned them into a group, either with no intervention or one in which they would participate in mindful yoga practice for three
months. The latter group was given a course in practicing mindfulness one week before beginning the 3 month mindful yoga practice. Mindful yoga sessions were an hour long and took place three times a week, over three months. The benefits of improved androgen levels, as well as reduced depression and anxiety, occurred in the absence of weight loss. Some participants also reported fewer acne breakouts and improved menstrual regularity, following the mindful yoga intervention. "Yoga has so many benefits," says Speelman. "One of its best qualities is that it is accessible to such a wide array of ages and fitness levels."
Women with PCOS have lower life satisfaction, poorer health beyond reproductive years Women with polycystic ovary syndrome (PCOS) experience poor health and quality of life into their late forties, according to new research published in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism. PCOS side effects extend beyond infertility and menstrual irregularities. Women with PCOS experience psychological issues like anxiety and depression that continue well beyond fertile age. The researchers studied a longitudinal cohort of 5,889 women at ages 31 and 46 and identified women with PCOS from this Northern Finland Birth Cohort 1966. The investigators found women with PCOS have poor health and quality of life compared to those without the condition. Mental distress was the strongest contributing factor to poor quality of life. "More interventions are needed to improve the quality of life for women with PCOS who are in their late thirties and forties. These women should be screened regularly for mental health issues and treated for other distressing symptoms like excess hair growth," Piltonen said.
07
The big WHY? From an evolutionary perspective, human pregnancy is quite strange, says University at Buffalo biologist Vincent Lynch. "For example, we don't know why human women go into labor," Lynch says. "Human pregnancy tends to last longer than pregnancy in other mammals if you adjust for factors like body size. The actual process of labor tends to last longer than in other animals. And human pregnancy and
labor are also much more dangerous." With these oddities in mind, Lynch and colleague Mirna Marinic set out to investigate the evolution of a gene that helps women stay pregnant: the progesterone receptor gene. But the results of the study only add to the mystery, says Lynch, PhD, an assistant professor of biological sciences in the UB College of Arts and Sciences.
Human pregnancy is weird
New research adds to the mystery
Scientists set out to investigate the evolution of a gene that helps women stay pregnant: the progesterone receptor gene. The results come from an analysis of the DNA of 115 mammalian species.
Strange findings Past research has shown that the progesterone receptor gene underwent rapid evolution in humans, and some scientists have suggested that these swift changes occurred because they improved the function of the gene. This is called positive selection. But Lynch and Marinic's study published online on in the journal PLOS Genetics begs to differ. Their research finds that while the progesterone receptor gene evolved rapidly in humans. In fact, the evolutionary force of selection was so weak that the gene accumulated many harmful mutations as it evolved in humans, Lynch says. The results come from an analysis of the DNA of 115 mammalian species. These included a variety of primates, ranging from modern humans and extinct Neanderthals to monkeys, lemurs and lorises, along
with nonprimate mammalian species such as elephants, pandas, leopards, hippos, aardvarks, manatees and walruses. “In human pregnancy, there's just an incredible amount of progesterone around, and yet the gene is less good at doing its job. I wonder if this might predispose us to things like preterm birth, which is not that common in other animals." says Lynch. Evolution changed the function of progesterone receptors in humans In addition to exploring the evolutionary history of the progesterone receptor gene, Lynch and Marinic conducted experiments to test whether mutations in the human version of the gene altered its function. The answer is yes.
FERTILITY SUPERHERO RECOMBINANT FOLLITROPIN ALFA R-HU FSH
09 Special Focus
What is it? Intro Inadequate concentrations of FSH, caused either by deficient FSH synthesis or secretion, are a common causeof infertility in men and women. Exogenous FSH is used clinically to treat women with anovulatory infertility, forcontrolled ovarian stimulation in women being treated with assisted reproductive technologies (ART), and inthe treatment of male hypogonadotrophic hypogonadism. The development of recombinant DNA technologyto produce recombinant human FSH (rhFSH) has resulted in significant
Human FSH Endogenous FSH is a glycoprotein hormone. It is composed of two non—covalently linked protein subunits, thealpha and beta subunits, to which carbohydrate moieties are attached. The alpha unit is similar to luteinizinghormone [LH], thyroid stimulating hormone [TSH] and human chorionic gonadotrophin [HCG]). It possessessimilar alpha but different specific beta subunits. The oligosaccharides in the beta subunit of FSH are highlyvariable and the composition and complexity of the attached carbohydrate moieties may differ. Each branch ofthe
improvements in the quality andavailability of gonadotrophin for clinical use. Two preparations of recombinant FSH are available follitropinalfa and follitropin beta. Follitropin alfa has a specific activity 100 times higher than that of other urinary derived FSHproducts. In contrast to the FSH content of urinaryderived FSH, that of recombinant FSH preparations can bequantified by protein content (mass in microgram) rather than by biological activity.
7
Recombinant human FSH (rhFSH) has changed the management of ART patients as well as ovulation induction.Follitropin alfa developed with recombinant DNA (rDNA) technology, is nearly identical to human FSH (folliclestimulating hormone), a gonadotrophin that plays an important role in human fertility and reproduction and intreatment of infertility such as induction of ovulation & ART. Recombinant gonadotrophin offer numerousadvantages over urinary products: high degree of purity (>99%), a high specific activity; no LH; an absence ofbiological contaminants; a lower interbatch variation; an unlimited possibility of production of the drug; ahigher effectiveness in inducing multifollicular development; and efficacy in 'poor responders'. This purity,batchtobatch consistency, and availability of rhFSH make it an attractive alternative to urinary FSH (uFSH).The technical advance of recombinant biotechnology ensures the production of quite consistent r hFSH. Theprotein content of rhFSH can be reliably quantified in mass, which allows rhFSH follitropin alfa to be filled inthe vial on the basis of mass (FbM). In clinical practice, the use offollitropin alfa FbM offers more precise dosingand optimal ovarian response.
oligosaccharides determines the terminal sialylation of the negatively charged FSH molecule and so anumber of isoforms exist. The basic isoforms have higher receptor affinity. Currently available two recombinant FSHpreparations follitropin alfa and follitropin beta are structurally identical to native FSH and, each comprisesone alpha and one beta glycoprotein chain. Recombinant FSH preparations differ from urinary humanmenopausal gonadotrophin (HMG) in their sialic acid content and have a shorter half life as they are more basic.
10
FSH in Folliculogenesis FSH and LH are the two main hormones involved in the stimulation of folliculogenesis and ovulation. Once secreted, FSH binds to receptors in the granulosa cells and stimulates the growth and development of the follicles, as well as promoting estradiol production. In addition, FSH induces follicular LH receptors, allowing ovulation and development of the corpus luteum in response to the LHsurge. LH is essential for steroidogenesis, specifically androgen synthesis. Ovarian follicles have a threshold requirement for circulating FSH, which is essential for their development. In normal menstrual cycle, only one follicle will be responsive to FSH above this threshold; this follicle has increased sensitivity to FSH and will
COH & ART
continue to develop when FSH levels begin to fall. The period of time where FSH is above this threshold level is called the 'FSH window’ and it is at this stage in follicular development that intervention with exogenous FSH is most often used. At midcycle LH surge evokes final maturation of oocyte & ovulation.
11 Benefits of Follitropin alfa • Pure • Absence of urinary protein • Administration: subcutaneous • Superior product consistency less batchtobatch variation in biologic activity • High specific activity. The availability of single use pre filled syringe formulation (PFS), multiple use vial & multiple use prefilled cartridge (to be used with an injection pen device) for the delivery of follitropin offers patients and healthcare professionals new treatment administration options. As fertility treatment cycles involve the use of several injectable gonadotrophin, a standard device that could be used for all such treatments would simplify both the administration and the teaching of administration considerably. These formulations do not require any reconstitution procedure and there is less chance of any contamination.
ADVANTAGES OF PEN DEVICE OF FOLLITROPIN ALFA OVER CONVENTIONAL INJECTION FORM • It is safe, convenient, and easy to use than the conventional syringe form • Accurate dosing and fewer dose adjustments. Allow flexible dosing that covers most treatment protocolsor dosing regimens • Local reactions at injection sites and pain are lower with the pen device than the conventional syringe • Selfadministration and patients' satisfaction are higher with the pen device as compared to conventional syringe • Training is easy for adminstrators
Pharmacodynamics Follitropin alfa is a recombinant Human Follicle Stimulating Hormone. In women, the most important effect ofparenteral administration of rHu FSH is the development of mature Graafian follicles. Follitropin alfa injectionstimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the activecomponent of follitropin alfa is the primary hormone responsible for follicular recruitment and development.In women with anovulation, the objective of follitropin alfa (rHu FSH) therapy is to develop a single maturegraafian follicle from which the ovum will be liberated after the administration of HCG. There is interpatientvariability in response to follitropin alfa (rHu FSH) administration. Patients with severe FSH and LH deficiencyare defined by an endogenous serum LH level <1.2 IU/l. However, it should be taken into account that there arevariations between LH measurements performed in different laboratories. In men deficient in FSH, rHu FSHadministered
concomitantly with HCG for at least 4 months induces spermatogenesis.
12 Exogenous FSH & PCOS Often ovulation induction in polycystic ovarian syndrome (PCOS) patients is difficult due to higher incidence ofclomiphene citrate resistance and higher risk of developing ovarian hyperstimulation and multiple gestationswhen gonadotrophin are used. Elevated LH levels during the follicular phase in women with PCOS have, beenassociated with poor reproductive outcomes. It has a deleterious effect on rates of conception and may be acausal factor in early pregnancy loss.11 Administering FSH without any LH activity is the best option for thesepatients. rhFSH, with no LH activity thus restores the normal hormonal balance in these women withpolycystic ovarian syndrome to induce follicular growth.
Controlled ovarian hyperstimulation with exogenous FSH in ART Although LH plays an important role during ovarian stimulation, excessive LH during the follicular phase hasbeen shown to have a detrimental effect on oocyte quality and thus fertility. Treatment with FSH, even in theabsence of LH, induces multiple follicular growth as well as meiotically and developmentally competentoocytes.Studies have shown that gonadotrophin preparations containing little LH activity combined with
pituitarydesensitization by a GnRH agonist (GnRHa) are effective in controlled ovarian stimulation, suggesting that inmost women, the remaining endogenous LH levels in these suppressed cycles are sufficient for folliculogenesis. The concentrations of residual endogenous LH remaining during fulldose GnRH agonist pituitary suppressionare sufficient to achieve adequate follicular maturation during ovarian stimulation with recombinant FSH.
13 Pharmacokinetics The pharmacokinetic properties of follitropin alpha are similar to those of urinary derived FSH. Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial halflife of around 2 hours and eliminated from the body with a terminal halflife of about one day. Oneeighth of the follitropin alfa dose is excreted in urine. Following subcutaneous administration, the absolute bioavailability is about 70%. Following repeated administration, it accumulates 3fold achieving a steady state within 34 days. INDICATIONS AND USAGE: • Anovulation (including polycystic ovarian syndrome, PCOD) in women who have been unresponsive to treatment with clomiphene citrate.
• Controlled ovarian hyper stimulation to induce the development of multiple follicles in medically assisted reproduction programmes (e.g. In vitro fertilization/embryo transfer (IVF/ET), gamete intra fallopian transfer (GIFT and intracytoplasmic sperm injection (ICSI) • In association with a luteinizing hormone preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency defined by an endogenous serum LH level < 1.2 IU/L • Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (HCG) therapy.
Dosage Women with anovulation (including PCOS): The dose must be individualized. The lowest dose expected to result in good response should be used. Inmenstruating women treatment should start within the first 7 days of the menstrual cycle. The individual patient's response is monitored by measuring follicle size by ultrasound and/or oestrogen secretion. A commonly used starting dose is 75150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7 orpreferably 14 day intervals if required, to obtain an adequate, but not excessive, response. The maximal dailydose is usually 225 IU FSH. If a patient fails to respond adequately after 4 weeks of treatment, that cycle shouldbe abandoned. The patient should undergo further evaluation after which she may recommence treatment ata higher starting dose than in the abandoned cycle. When an optimal response is obtained, a single injection of 250 micrograms recombinant human choriogonadotropin alfa (rHCG) or 5,000 IU, up to 10,000 IU HCG should be administered 2448 hours after the last follitropin alfa (rHu FSH) injection. The patient is recommended to have coitus on the day of, and the day following, HCG administration. Alternatively intrauterine insemination (IUI) may be performed. If an excessive response is obtained, treatment should be stopped and HCG withheld.
Treatment should restart in the next cycle at a dose lower than that of the previous cycle. Protocols for induction of ovulation: Various protocols are used for ovulation induction with gonadotrophin. The stepup protocol allows the FSH threshold to be reached gradually, which reduces the risk of excessive stimulation and development of multiple preovulatory follicles. In the stepup protocol the FSH dose is increased by < 75 IU every 5 to 7 days, while in the chronic lowdose regimen, it is administrated at a low dose for 14 days followed by small incremental dose increases (when necessary), at intervals not shorter than 7 days, until follicular development is initiated. In step down protocol, regimens normally begin therapy with 150 IU/day started shortly after a spontaneous or progesterone induced bleeding. The starting dose in the stepdown protocol can be determined with one cycle of the stepup protocol. This dose is continued until a dominant follicle (2 10 mm) is seen on USG. The dose is then decreased to 112.5 IU/day followed by a further decrease to 75 IU 3 days later, which is continued until HCG is administered to induce ovulation. If no ovarian response is observed after 3 5 days, the FSH dose can be further increased.
14 Dosage Women with anovulation resulting from severe LH and FSH deficiency: The objective of follitropin alfa (rHu FSH) therapy in association with lutropin alfa in LH and FSH deficient women (hypogonadotrophic hypogonadism), is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of HCG. Follitropin alfa (rHu FSH) should be given as a course of daily injections simultaneously with lutropin alfa. A recommended regimen is to start with 75 IU of lutropin alfa daily with 75150 IU rHu FSH. Treatment should be tailored to the individual patient's response. The response is assessed by follicle size measured by ultrasound and oestrogen response. If an increment in FSH dose is required, dose adaptation should preferably be after 714 day intervals and preferably by 37.575 IU increments. The duration of stimulation may extend in any one cycle to up to 5 weeks. When an adequate response is obtained, a single injection of 250 micrograms rHCG or 5,000 IU up to 10,000 IU HCG should be administered 2448 hours after the last follitropin alfa and lutropin alfa injections.The patient is recommended to have coitus on the day of, and on the day following, HCG administration. Alternatively, intrauterine insemination (IUI) may be performed. Luteal phase support may be recommended. If an excessive response is obtained, treatment should be stopped
and HCG withheld. Treatment should restart in the next cycle at a dose of FSH lower than that of the previous cycle. Women undergoing ovarian stimulation for multiple follicular development: Various protocols are used for ovulation induction with gonadotrophin. The stepup protocol allows the FSH threshold to be reached gradually, which reduces the risk of excessive stimulation and development of multiple preovulatory follicles. In the stepup protocol the FSH dose is increased by < 75 IU every 5 to 7 days, while in the chronic lowdose regimen, it is administrated at a low dose for 14 days followed by small incremental dose increases (when necessary), at intervals not shorter than 7 days, until follicular development is initiated. In step down protocol, regimens normally begin therapy with 150 IU/day started shortly after a spontaneous or progesterone induced bleeding. The starting dose in the stepdown protocol can be determined with one cycle of the stepup protocol. This dose is continued until a dominant follicle (2 10 mm) is seen on USG. The dose is then decreased to 112.5 IU/day followed by a further decrease to 75 IU 3 days later, which is continued until HCG is administered to induce ovulation. If no ovarian response is observed after 3 5 days, the FSH dose can be further increased.
Administration • Follitropin alfa (rHu FSH) is intended for subcutaneous administration in both men and women. The first injection of Follitropin alfa (rHu FSH) should be administered under direct medical supervision. Selfadministration of rHu FSH should only be performed by patients who are well motivated, adequately trained and have access to expert advice. Suitable site for subcutaneous administration is in the abdomen around the navel. Change the injection site with each injection. • The solution should not be administered if it contains particles or is not clear. The prefilled syringe is for singleuse. Multiple use prefilled cartridge is to be used in conjunction with the folisurge pen device.
As Follitropin alfa(rHu FSH) multiple use prefilled cartridges and multiple use vial are intended for several injections, clear instructions should be provided to the patients to avoid misuse of the multidose presentation. Any unused solution must be discarded not later than 28 days after first opening. Discard used needles immediately after injection.
Contra-indications Follitropin alfa is contraindicated in, women and men who exhibit: • Prior hypersensitivity to recombinant FSH preparations or one of their excipients • high levels of FSH indicating primary gonadal failure • uncontrolled thyroid or adrenal dysfunction • sex hormone dependent tumors of the reproductive tract and accessory organs • an organic intracranial lesion such as a pituitary tumor. It is also contraindicated in women who exhibit: • Abnormal uterine bleeding of undetermined origin • ovarian cyst or enlargement of undetermined origin • pregnancy.
7
15
Safety Profile DRUG INTERACTIONS Concomitant use of follitropin alfa with other drugs used to stimulate ovulation (e.g. HCG, clomiphene citrate) may potentiate the follicular response. Concurrent use of a GnRH agonist or antagonist to induce pituitary desensitization may increase the dose of Follitropin alfa required. Follitropin alfa is welltolerated by patients. • The most commonly reported adverse reactions are: headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, hematoma, swelling and/or irritation at the site of injection). • Mild or moderate ovarian hyperstimulation syndrome (OHSS) may occur and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon. • Thromboembolism may occur very rarely, usually associated with severe OHSS. Ovarian hyperstimulation syndrome (OHSS) & multiple pregnancies: When used for induction of ovulation, rhFSH is associated with low risk of OHSS. The systematic review of trials comparing rFSH to urinary HMG in IVF showed that there is no difference in the rate of OHSS. After pooling results from 4 randomized trials including 381 participants undergoing IVF in GnRH agonist down regulated cycles, there was no difference in the incidence of OHSS between women who received rLH plus rFSH and those who received rFSH alone.
7
16 7
Clinical ef ficacy of Follitropin alfa rhFSH and HMG are the most frequently used gonadotrophin for COS for IVF/ICSI. Several trials have compared the effectiveness of urinary and recombinant gonadotrophin in • anovulatory patients • patients undergoing controlled ovarian stimulation for ART • patients undergoing ovarian stimulation cycles associated withintrauterine insemination. These trials have demonstrated greater efficacy of r hFSH compared to uFSH andHMG as under: • In patients undergoing induction of ovulation, the total dose of FSH required is lower when the recombinant preparation is used (a lower total dose administered over a shorter period oftime) • Lower dose of rFSH is required as compared to uFSH, in patients in ovarian stimulation cycles associated with intrauterine insemination.
Several trials have demonstrated that rhFSH is more effective in follicular development in ART: • rFSH yield more oocytes (and more mature oocytes), versus HMGHP using less IU per cycle. • Lower dose of rFSH is required as compared to uFSH, in patients in ART program undergoing pituitary suppression. • The use of follitropin alfa in assisted reproduction is preferred over uFSH. • rFSH produces higher pregnancy rates per cycle than uFSH when follitropin alpha is used in IVF, & total gonadotrophin dose is less. • It has a higher efficacy in poor responders. • In clinical practice, the use of follitropin alfa FbM offers more precise dosing and optimal ovarian response and fewer cycle cancellations.
A recent retrospective chart review of databases from European countries involving 30,630 IVF cycles foundthat IVF treatment cycles with rFSH yield statistically more oocytes (and more mature oocytes), usingsignificantly less IU per cycle, versus HMGHP. 74% used rFSH and 26% used HMGHP.
17 Summary In clinical practice, the use of follitropin alfa FbM offers more precise dosing and optimal ovarian response and fewer cycle cancellations. Efficacy at rFSH in induction of ovulation in PCOS: Recombinant FSH such as follitropin alfa is favored over HMG or uFSH in ovulation induction programmes, and it is proved to be effective and safe in both chronic low dose and conventional protocols. Randomized trials comparing RhFSH to other gonadotrophin preparations in patients undergoing induction of ovulation, have shown that the total dose of FSH required is lower when the recombinant preparation is used. Efficacy at rFSH in intrauterine insemination (IUI): Lower dose of rFSH is required as compared to uFSH, in patients in ovarian stimulation cycles associated with intrauterine insemination. Several trials have demonstrated that rFSH is more effective in follicular development in ART: • rFSH yields more oocytes (and more mature oocytes), versus HMGHP using less IU (less drug usage)per cycle
• Lower dose of rFSH is required as compared to uFSH, in patients in ART program undergoing pituitary suppression • The use of follitropin alfa in assisted reproduction is preferred over uFSH • rFSH produces higher pregnancy rates per cycle than uFSH when follitropin alpha is used in IVF, & total gonadotrophin dose is less • It has a higher efficacy in poor responders • In clinical practice, the use of follitropin alfa FbM offers more precise dosing and optimal ovarian response and fewer cycle cancellations SAFETY PROFILE OF FOLLITROPIN ALPHA: Follitropin alpha is very well tolerated by the patients. It is associated with fewer injection site side effects. The systematic review of trials comparing rFSH to urinary HMG in IVF showed no difference in multiple pregnancy rates & in the rate of OHSS between the two treatment groups.
7
Say Yes to Folisurge • "Folisurge" is a recombinant Human Follicle Stimulating Hormone solution for injection. • It has high specific activity and displays a better batchto batch consistency because of the carefully controlled manufacturing conditions. • Folisurge is available as singleuse prefilled syringe, multiple use prefilled cartridges (to be used in conjunction with the folisurge pen device) and multiple use vial formulations. • The specially designed formulations of Folisurge allow simple and flexible dosing that covers most treatment protocols or dosing regimens. • In clinical practice, the use of follitropin alfa FbM offers more precise dosing and optimal ovarian response and fewer cycle cancellations.
weird and wonderful fertility superstitions Since the 17th Century the Cerne Abbas Giant in Dorset has been apparently boosting women’s fertility. Any woman who sleeps on the naked chalk figure will soon fall pregnant, according to folklore, and have a wild guess where on his body they usually decide to have a kip.
In Nigeria the annual weeklong Osun-Osgogbo festival paying homage to the goddess of fertility is thousands of years old. The high point of the festival is when a virgin carries sacred objects to the river Oshun where the goddess of water is said to live.
Couples who want a helping hand with fertility head to the grave of Victor Noir. The lady hoping to be a mother has to kiss the statue on the lips, place a flower in his upturned hat and rub his trousers. Now nearly 150 years later the statue’s lips and crotch are bright and shiny whereas the rest of him remains almost untouched.
Does the coronavirus affect male fertility?
FACT CHECK
There have been repeated suggestions on social media and in newspaper reports that COVID19 might dam age male fertility. The concerns have in part arisen because the testes are known to produce the protein that the novel coro navirus is thought to use to get into cells (called ACE2). So theoretically the testes could be affected by the virus. There is also some evidence that illness and high tem perature caused by some in fections including flu, can temporarily lower sperm count and increase the pro duction of abnormal sperm,
but this effect is short lived. One study in 181 men from China found that men with COVID19 seem to have changes in levels of some of their reproductive hor mones compared to men without the virus but found no difference in testos terone levels. Two studies from China found no evi dence of the virus in the semen of men who had re covered from COVID19. No studies so far have looked at important issues such as sperm count or quality, so there isn’t con vincing evidence that COVID19 impacts men’s fertility.