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

NCT06766604 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-07-10

No results posted yet for this study

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.

Conditions

  • In Vitro Fertilization

Interventions

OTHER

Super-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.

OTHER

Conventional 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.

Sponsors & Collaborators

  • Vrije Universiteit Brussel

    collaborator OTHER

  • Mỹ Đức Hospital

    lead OTHER

Principal Investigators

  • Lan N Vuong · University of Medicine and Pharmacy at Ho Chi Minh City

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2025-02-17
Completion
2026-04-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06766604 on ClinicalTrials.gov