Effect of Super-GDF9 Addition During Capacitation-In Vitro Maturation (CAPA-IVM) of Donated Human Cumulus-Oocyte Complexes From Small Antral Follicles

What this Trial Is About

Researchers are investigating the use of CAPA-IVM (In Vitro Maturation) technology, an assisted reproductive method that offers advantages in safety and treatment cost, especially for women at high risk such as those with ovarian hyperstimulation syndrome, venous thrombosis, ovarian torsion, or polycystic ovary syndrome (PCOS). While CAPA-IVM shows a live birth rate comparable to conventional IVF, the number of good-quality embryos and overall pregnancy rates are lower. This trial aims to improve CAPA-IVM outcomes by supplementing the culture with super GDF9, a potent growth factor that supports follicular development and oocyte quality. The study compares two groups of cumulus-oocyte complexes (COCs) collected from small follicles during oocyte pick-up procedures. One group will receive CAPA-IVM culture with added super GDF9 at 50 ng/ml during both capacitation and maturation steps, while the control group will undergo the same CAPA-IVM process without super GDF9. Fertilization will be performed by intracytoplasmic sperm injection (ICSI), and samples such as spent media and cumulus cells will be collected for analysis. Participants will undergo screening and consent before oocyte retrieval, with follow-up assessments at specific time points after fertilization to measure outcomes like maturation rates, fertilization rates, embryo quality, and gene expression. The primary outcome is the maturation rate per COC two days after retrieval. Secondary outcomes include degeneration rates, embryo development timing, blastocyst quality, and genetic evaluations extending up to about one year after study completion. The study plans to enroll around 10 patients to obtain 300 COCs for analysis.

Effect of Super-GDF9 on CAPA-IVM of COCs From Small Antral Follicles