Actively Recruiting

Phase Not Applicable
Age: 18Years - 38Years
FEMALE
NCT06766604

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

Led by Mỹ Đức Hospital · Updated on 2025-07-10

9

Participants Needed

1

Research Sites

67 weeks

Total Duration

On this page

Sponsors

M

Mỹ Đức Hospital

Lead Sponsor

V

Vrije Universiteit Brussel

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 38Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 38 years (inclusive)
  • Body mass index (BMI) of 32 kg/m2 or less
  • Diagnosis of polycystic ovary syndrome (PCOS) according to Rotterdam criteria (2003)
  • Indicated for CAPA-IVM treatment
  • Serum AMH level of 4 ng/mL or higher at screening
  • At least 24 antral follicles in both ovaries by transvaginal ultrasound at CAPA-IVM indication
  • Willing to donate cumulus-oocyte complexes (COCs) for research
  • Agreement to use frozen embryos
  • Signed informed consent before any study procedures
Not Eligible

You will not qualify if you...

  • Known endometrioma or grade 3-4 endometriosis by ASRM classification
  • Presence of uterine abnormalities
  • Severe male factor infertility (sperm concentration less than 5 million/ml, motility less than 10%) or requiring surgical sperm retrieval
  • Previous history of unexplained immature oocytes after IVF treatment
  • Use of donor oocytes in current cycle

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

My Duc Hospital

Ho Chi Minh City, Vietnam

Actively Recruiting

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Research Team

K

Kha T Huynh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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