Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective Study.

Background: Biosimilar drugs have broadened the treatment options in assisted reproductive technology (ART). Real-world data comparing clinical outcomes of originator follitropin alfa (Gonal-f®) with its biosimilars are required to enrich the body of evidence for clinical decision-making on choice of drug. Aims: To compare the ART outcomes in patients receiving originator follitropin (Gonal-f®) and its biosimilars in clinical setting. Settings and Design: Medical records of 364 infertile women who underwent ART between 2016 and 2020 at Akanksha Hospital and Research Institute, Gujrat, India, were retrospectively analysed. Materials and Methods: Participants were divided into two cohorts based on treatment (Gonal-f® cohort; N = 174 and biosimilar cohort; N = 190), each cohort further subdivided into group A (age <35 years) and group B (age ≥35 years). Fresh or frozen embryo transfer was performed as per the standard procedures of the clinic. Pregnancy rates and live birth rate (LBR) were the primary main outcome measures in this study. Statistical Analysis Used: Descriptive statistics and Chi-square test were used for analysis. Results: The number of oocytes retrieved from Gonal-f® and biosimilar cohorts were comparable (13.3 vs. 14.4). Compared to biosimilars, Gonal-f® treatment resulted in higher yield of cleavage stage and blastocyst stage embryos, and the proportion of women with good quality embryos was higher in the Gonal-f® cohort than the biosimilar cohort (83.3% vs. 69.5%). Patients receiving Gonal-f® reported higher pregnancy rates (59.2% vs. 39.7%) and LBR (43% vs. 17.7%) compared to those receiving biosimilars. Conclusions: Gonal-f® (originator follitropin) treatment could result in higher pregnancy rates and LBR in comparison to biosimilars in real-world setting.

Distinct gut and vaginal microbiota profile in women with recurrent implantation failure and unexplained infertility.

BACKGROUND: Female reproductive tract dysbiosis impacts implantation. However, whether gut dysbiosis influences implantation failure and whether it accompanies reproductive tract dysbiosis remains scantly explored. Herein, we examined the gut-vaginal microbiota axis in infertile women. METHODS: We recruited 11 fertile women as the controls, and a cohort of 20 infertile women, 10 of whom had recurrent implantation failure (RIF), and another 10 had unexplained infertility (UE). Using amplicon sequencing, which employs PCR to create sequences of DNA called amplicon, we compared the diversity, structure, and composition of faecal and vaginal bacteria of the controls with that of the infertile cohort. Of note, we could only sequence 8 vaginal samples in each group (n = 24/31). RESULT: Compared with the controls, α-diversity and ß-diversity of the gut bacteria among the infertile groups differed significantly (p < 0.05). Taxa analysis revealed enrichment of Gram-positive bacteria in the RIF group, whereas Gram-negative bacteria were relatively abundant in the UE group. Strikingly, mucus-producing genera declined in the infertile cohort (p < 0.05). Hungatella, associated with trimethylamine N-oxide (TMAO) production, were enriched in the infertile cohort (p < 0.05). Vaginal microbiota was dominated by the genus Lactobacillus, with Lactobacillus iners AB-1 being the most abundant species across the groups. Compared with the infertile cohort, overgrowth of anaerobic bacteria, associated with vaginal dysbiosis, such as Leptotrichia and Snethia, occurred in the controls. CONCLUSION: The gut microbiota had little influence on the vaginal microbiota. Gut dysbiosis and vaginal eubiosis occurred in the infertile women, whereas the opposite trend occurred in the controls.

Birth of a healthy infant after bone marrow-derived cell therapy.

Bone marrow-derived cell (BMDC) therapy has numerous applications as potential biological cells for use in regenerative medicine. Here, we present an original case of endometrial atrophy associated with genital tuberculosis in a woman who achieved a live birth with BMDC. This 27-year-old woman came to our center with endometrial atrophy and primary infertility. She had a past history of genital tuberculosis and amenorrhea. Her husband's semen quality was normal. The patient was counseled for hysteroscopy due to thin endometrium and advised in vitro fertilization (IVF) with donor eggs in lieu of poor ovarian reserve. Several attempts of IVF with hormone replacement therapy (HRT) were made, but the desired thickness of the endometrium was not achieved. Uterine artery injection of BMDC through interventional radiology was given, followed by HRT for three months, which resulted in improved endometrium. This was subsequently followed by IVF with donor egg. The treatment resulted in the conception and delivery of a 3.1-kg baby boy through lower segment caesarean section with no antenatal, intranatal or postnatal complications. Recently, there has been massive interest in stem cells as a novel treatment method for regenerative medicine, and more specifically for the regeneration of human endometrium disorders like Asherman syndrome and thin endometrium, which was the reason behind using this strategy for treatment.

Drug-free In vitro Activation for Primary Ovarian Insufficiency.

Primary Ovarian Insufficiency (POI) or Diminished Ovarian Reserve (DOR) are the two conditions that affects women leading to infertility due to the lack of follicular growth and ovulation. Egg / Oocyte donation remains an option for these patients. However, with the development in Reproductive medicine various novel technologies like Ovarian Cryopreservation, Fragmentation, in vitro activation with drug treatment or even drug free autotransplantation enables the possibility of activating the pool of primordial follicles that can lead to successful pregnancy outcomes. Here, we report a case of women with POI, in which drug free in vitro activation of follicles was performed, followed by autotransplantation, which resulted in successful pregnancy. This is first case report from India that shows the procedure works and can be tried for women with POI.

Insight into Different Aspects of Surrogacy Practices.

Surrogacy is an important method of assisted reproductive technology wherein a woman carries pregnancy for another couple. Number of couples around the world require surrogacy services for various reasons. Although this arrangement seems to be beneficial for all parties concerned, there are complex social, ethical, moral, and legal issues associated with it. It is these complexities that have made this practice unpopular in many parts of the world. Surrogacy in India has had its own journey from India becoming popular as a surrogacy center since 2002 to the Surrogacy (Regulation) Bill, 2016, which would restrict the option of surrogacy for many. Surrogacy is an important medical service for all those couples who would otherwise not have been able to produce a child. Surrogacy would be practiced harmoniously if delicate issues associated with surrogacy will be addressed properly through appropriately framed laws which would protect the rights of surrogate mothers, intended parents, and child born through surrogacy.

Impact of embryo co-culture with cumulus cells on pregnancy & implantation rate in patients undergoing in vitro fertilization using donor oocyte.

BACKGROUND & OBJECTIVES: Cumulus cell co-culture of embryo had been found to be beneficial for achieving better pregnancy and implantation rate (IR). The present study was aimed to evaluate efficiency of cumulus co-culture technique over simple culture of embryo in terms of pregnancy rate (PR) and IR in patients undergoing treatment for infertility using donor oocytes fertilized by intracytoplasmic sperm injection. METHODS: This was a quasi-experimental study between control and study groups. The primary endpoint was achievement of pregnancy. Control group included 508 women who underwent embryo development without cumulus cell co-culture and study group included 394 women who underwent embryo development with cumulus cell co-culture using donor's cumulus cells. RESULTS: The present study demonstrated a significant increase in the IR (37.2 vs 24.2%, P<0.001) and in PR (45.7 vs 37.8%, P<0.05) in study group than in control group. The PR and IR were found to be higher in study group, among all groups of women, grouped on the basis of different indications for use of donor oocytes. INTERPRETATION & CONCLUSIONS: Cumulus cell co-culture technique was found to be more effective than simple culture technique for embryo development in women undergoing treatment for infertility using donor oocytes fertilized by intracytoplasmic sperm injection.