About this trial
CAPA-IVM (In Vitro Maturation) technology is an assisted reproductive method offering significant benefits in terms of safety and treatment costs, particularly for high-risk patients. These include individuals with ovarian hyperstimulation syndrome (OHSS), venous thrombosis, ovarian torsion, or polycystic ovary syndrome (PCOS). However, while the live birth rate in the CAPA-IVM group (35.2%) is comparable to conventional IVF (43.2%), the number of good-quality embryos and cumulative clinical pregnancy rates remain lower. Improving the CAPA-IVM culture process, particularly through the addition of growth factors found in follicular fluid, has shown promise in enhancing oocyte quality.
Growth differentiation factor 9 (GDF9) and Bone morphogenetic protein 15 (BMP15) play critical roles in follicular development, with their heterodimer structure demonstrating the most positive effects on cumulus-oocyte complexes (COCs). Recent studies have identified a potent variant, super GDF9, which is \>1000 times more effective than GDF9 and surpasses cumulin, a heterodimeric growth factor. Super GDF9 enhances cumulus cell expansion and oocyte developmental competence, closely mimicking in vivo maturation.
This study investigates the impact of supplementing super GDF9 during CAPA-IVM culture, aiming to improve outcomes of cumulus-oocyte complexes (COCs) from small follicles and ultimately enhance treatment success.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women between the ages of 18 and 38 years (both inclusive)
BMI ≤ 32 kg/m2
PCOS women according to the Rotterdam criteria (2003)
Indicating CAPA-IVM treatment.
Disqualifiers
Known endometrioma or grade 3-4 endometriosis according to ASRM classification
Uterine abnormalities
Couples with severe male factor (sperm concentration <5 million/ml, motility < 10%), surgical sperm retrieval.
Previous history of unexplained immature oocytes after IVF treatment
Trial design
Parallel
Treatments tested in this trial
Super-GDF9 supplementation during CAPA-IVM
Other interventionGroup 1: donated COCs will be exposed to Super-GDF9 at 50 ng/ml in both the CAPACITATION and MATURATION culture steps.
Conventional CAPA-IVM
Other interventionGroup 2: The subject's remaining COCs will be cultured in the CAPA step and the IVM step without the addition of Super-GDF9 during CAPA-IVM.
Treatment groups
Trial outcomes
Primary outcomes
Maturation rate per COC
Number of MII / COCs
Secondary outcomes
Maturation rate per patient
Number of MII / patient
Degeneration rate per COC
Number of degenerated oocytes after IVM / COCs
Degeneration rate per MII
Number of degenerated oocytes after IVM / MII
Degeneration rate per patient
Number of degenerated oocytes after IVM / patients
Sponsors and contacts
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Mỹ Đức Hospital
Lead sponsor
Vrije Universiteit Brussel
Collaborator