FSH-free vs. FSH-primed Infertility Treatment in Women with PCOS using Biphasic In Vitro Maturation: A Randomized Clinical Trial

A randomized, controlled trial was recently carried out at a tertiary IVF center in Ho Chi Minh City, Vietnam. Conducted between January and June 2023, the trial involved 120 women aged 18-37 years, all diagnosed with polycystic ovarian syndrome (PCOS). The study aimed to evaluate the effectiveness of CAPA-IVM (biphasic in vitro maturation) with and without FSH-priming.

Participants provided written informed consent and were randomly assigned to one of two groups: one group received recombinant FSH (rFSH) injections for two days before oocyte pick-up, while the other group did not receive any rFSH. All retrieved cumulus oocyte complexes underwent CAPA-IVM, and matured oocytes were fertilized using the ICSI procedure. The embryos were cultured to the blastocyst stage and then vitrified. Each participant later underwent a single blastocyst transfer during a frozen replacement cycle.

The primary metric for the study was the number of matured oocytes. Results showed no significant difference between the two groups: the non-FSH group had a median of 13 matured oocytes, while the FSH group had a median of 14. Other oocyte and embryology outcomes, such as the number of cumulus-oocyte complexes, fertilized oocytes, blastocysts, good-quality blastocysts, and frozen embryos, also showed no significant differences between the groups.

Live birth rates were 38.3% in the non-FSH group and 31.7% in the FSH group, again showing no statistically significant difference. The miscarriage rate at less than 12 weeks’ gestation was 5% in both groups. Maternal complications were rare and occurred at similar rates in both groups, with no preterm deliveries before 32 weeks’ gestation.

These findings were presented by Dr. Tuong M. Ho at the 40th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Amsterdam on July 9th, 2024. The study is currently under submission for publication in a leading reproductive medicine journal.

Prof. Dr. Lan Vuong of The University of Medicine and Pharmacy at Ho Chi Minh City and MyDuc Hospital in Vietnam, who led the study, commented on the results: “This trial with 120 patients demonstrates that CAPA-IVM without rFSH priming is as effective as with two days of rFSH priming. Achieving a 38% live birth rate for single blastocyst transfer, CAPA-IVM matched the success rates of standard IVF with 8-10 days of rFSH treatment. This is a significant milestone, supporting our belief that women with PCOS can benefit from a complete gonadotrophin-free, alternative fertility treatment.”

CAPA-IVM represents a novel approach to the in-vitro maturation of oocytes. This method incorporates a capacitation step to enhance oocyte developmental competence, allowing for minimal or no ovarian stimulation. CAPA-IVM presents a patient-friendly alternative to conventional ovarian stimulation and IVF, lowering the treatment burden for some patient groups.

The worldwide rights to CAPA-IVM technology are held by Lavima Fertility, Inc., which is also developing a medical device for future application of this technology.