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

Recruiting now · Not applicable

Conditions studied: In Vitro Fertilization

In brief

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.

Key facts

Study ID

NCT06766604

Run by

Mỹ Đức Hospital

People needed

9

Starts

2025-01-10

Expected to finish

2026-04-30

Last updated by the study team

2025-07-10

Who can join

Age: 18 and older, up to 38. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Serum AMH ≥ 4 ng/mL (28.57 pmol/L) at screening and having at least 24 antral follicles in two ovaries by transvaginal ultrasound at the time of CAPA-IVM indication
• Willing to donate COCs for research purposes
• Agreeing for frozen embryo
• Signed informed consent before any study-related procedures

You may not qualify if…

• 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
• Cycles using donor oocytes

Where it is running

• My Duc Hospital — Ho Chi Minh City, Vietnam (enrolling)

Full record on ClinicalTrials.gov

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