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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-38
SponsorMỹ Đức Hospital

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

Qualifiers

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

Treatments tested in this trial

  • Super-GDF9 supplementation during CAPA-IVM
  • Conventional CAPA-IVM

Treatment groups

9 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mỹ Đức Hospital

Lead sponsor

Vrije Universiteit Brussel

Collaborator