Effect of Super-GDF9 on CAPA-IVM of COCs From Small Antral Follicles
Recruiting · NCT06766604 · Interventional (participants receive a specific treatment) · Lead sponsor: Mỹ Đức Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed.
- My Duc Hospital - Ho Chi Minh City, Vietnam