Hormone-free Vs. Follicle-stimulating Hormone-primed Infertility Treatment of Women with Polycystic Ovary Syndrome Using Biphasic In vitro Maturation: a Randomized Controlled Trial

Objective: To compare oocyte maturation rates and pregnancy outcomes in women with polycystic ovary syndrome (PCOS) undergoing biphasic in vitro maturation (capacitation in vitro maturation [CAPA-IVM]) with vs. without follicle-stimulating hormone (FSH) priming.

Design: Randomized, controlled, assessor-blinded trial.

Subjects: Women aged 18-37 years with PCOS and an indication for CAPA-IVM.

Intervention(s): Participants were randomized (1:1) to undergo CAPA-IVM with or without FSH priming. The FSH priming group had 2 days of FSH injections before oocyte pickup; no FSH was given in the non-FSH group. After CAPA-IVM, day-5 embryos were vitrified for transfer in a subsequent cycle.

Main Outcome Measure(s): The primary endpoint was number of matured oocytes. Secondary outcomes included rates of live birth, implantation, clinical pregnancy, ongoing pregnancy, pregnancy complications, obstetric and perinatal complications, and neonatal complications.

Result(s): The number (interquartile range) of matured oocytes did not differ significantly in the non-FSH vs. FSH group (13 [9-18] vs. 14 [7-18]; absolute difference -1 [95% confidence interval -5 to 4]); other oocyte and embryology outcomes did not differ between groups. Rates of ongoing pregnancy and live birth were 38.3% in the non-FSH group and 31.7% in the FSH group (risk ratio for both outcomes: 1.21, 95% confidence interval 0.74-1.98). Maternal complications were infrequent and occurred at a similar rate in the two groups; there were no preterm deliveries before 32 weeks gestation.

Conclusion(s): These findings open the possibility of a new, hormone-free approach to infertility treatment of women with PCOS.

Clinical Trail Registration Number: NCT05600972.