RecruitingNot ApplicableNCT06766604

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

Exploratory In-vitro Study Evaluating the Addition of Super-GDF9 During Capacitation-in-vitro Maturation (CAPA-IVM) of Donated Human Cumulus-oocyte Complexes (COCs) Derived From Small Antral Follicles


Sponsor

Mỹ Đức Hospital

Enrollment

9 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 38 Years

Inclusion Criteria8

  • 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 Criteria5

  • 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

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Interventions

OTHERSuper-GDF9 supplementation during CAPA-IVM

Group 1: donated COCs will be exposed to Super-GDF9 at 50 ng/ml in both the CAPACITATION and MATURATION culture steps.

OTHERConventional CAPA-IVM

Group 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.


Locations(1)

My Duc Hospital

Ho Chi Minh City, Vietnam

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NCT06766604