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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-38
SponsorMỹ Đức Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Super-GDF9 supplementation during CAPA-IVM

    Other intervention

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

  • Conventional CAPA-IVM

    Other intervention

    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.

Treatment groups

9 Participants
are divided into 2 treatment groups
Group A: Super-GDF9 supplementation during CAPA-IVMExperimental treatment 1 intervention
Group B: Conventional CAPA-IVMActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maturation rate per COC

Number of MII / COCs

Time frame
Two days after oocyte retrieval

Secondary outcomes

1

Maturation rate per patient

Number of MII / patient

Time frame
Two days after oocyte retrieval
2

Degeneration rate per COC

Number of degenerated oocytes after IVM / COCs

Time frame
16-18 hours after Intra-cytoplasmic sperm injection
3

Degeneration rate per MII

Number of degenerated oocytes after IVM / MII

Time frame
16-18 hours after Intra-cytoplasmic sperm injection
4

Degeneration rate per patient

Number of degenerated oocytes after IVM / patients

Time frame
16-18 hours after Intra-cytoplasmic sperm injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mỹ Đức Hospital

Lead sponsor

Vrije Universiteit Brussel

Collaborator