Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer

Summary

This study is testing whether eggs can be collected from small follicles without using the usual ovarian stimulation medications. Participants will have up to three egg retrieval procedures. The eggs collected during each retrieval will be matured in the laboratory using the CAPA-IVM (Capacitation In Vitro Maturation) process, fertilized, grown into embryos, and tested to identify chromosomally normal embryos. Embryos from the retrievals may be frozen and accumulated. If a suitable embryo is available, one chromosomally normal embryo may be transferred. The study will also monitor safety, hormone levels, follicle development, embryo development, pregnancy results, and how well participants tolerate the study procedures.

Detailed Description

This is a single-arm, prospective, open-label, adaptive pilot study designed to evaluate the feasibility of serial unstimulated transvaginal oocyte retrieval followed by CAPA-IVM (Capacitation In Vitro Maturation) for euploid embryo accumulation in infertility patients with robust ovarian reserve. Approximately 30 participants will be enrolled. Participants will undergo serial unstimulated transvaginal oocyte retrieval procedures targeting visible 4-9 mm antral follicles. Retrieved cumulus-oocyte complexes will undergo CAPA-IVM (Capacitation In Vitro Maturation), followed by intracytoplasmic sperm injection, blastocyst culture, preimplantation genetic testing for aneuploidy, and embryo vitrification/accumulation. Euploid embryos generated across retrievals will be accumulated for subsequent single euploid embryo transfer according to the protocol and site clinical practice. The study will be conducted in two stages. Stage 1 will enroll approximately 10 participants using initially defined serial retrieval timing to evaluate feasibility, safety, follicle availability, and retrieval interval optimization. Following review of Stage 1 safety, feasibility, follicle emergence, and endocrine data, Stage 2 will enroll approximately 20 additional participants. Retrieval intervals in Stage 2 may be adjusted if supported by interim findings. The study will summarize retrieval-specific and participant-level outcomes, including follicle counts, oocyte yield, oocyte maturation, fertilization, blastocyst development, PGT-A (Preimplantation Genetic Testing for Aneuploidy) results, euploid embryo yield, embryo accumulation, and progression to single euploid embryo transfer. Safety and tolerability will be assessed throughout the study, including procedure-related complications, anesthesia/sedation-related events, antibiotic-related reactions, retrieval deferrals or discontinuations, and other adverse events.

Eligibility Criteria

Interventions