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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 38
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Viet Nam
My Duc Hospital
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Kha T Huynh
kha.ht@myduchospital.vn
+84946699470
Time Frame
Start Date: 2025-01-10
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 9
Treatments
Experimental: Super-GDF9 supplementation during CAPA-IVM
Group 1: donated COCs will be cultured in the CAPA step and the IVM step, with the addition of Super-GDF9 during CAPA-IVM.
Active_comparator: 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
Leads: Mỹ Đức Hospital
Collaborators: Vrije Universiteit Brussel

This content was sourced from clinicaltrials.gov