Using Super-GDF9 to Improve Oocyte Quality in In Vitro Fertilization
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
NA · Mỹ Đức Hospital · NCT06766604
This study is testing if adding Super-GDF9 can help improve egg quality during a specific fertility treatment for women with PCOS who are looking for a safer and more affordable alternative to traditional IVF.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | Mỹ Đức Hospital (other) |
| Locations | 1 site (Ho Chi Minh City) |
| Trial ID | NCT06766604 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Super-GDF9 supplementation during CAPA-IVM, an assisted reproductive technology aimed at improving oocyte quality for women with conditions like PCOS. The study focuses on high-risk patients who may benefit from a safer and more cost-effective alternative to conventional IVF. By enhancing the culture process with growth factors found in follicular fluid, the trial aims to increase the number of good-quality embryos and improve cumulative clinical pregnancy rates. Participants will be women aged 18 to 38 with specific eligibility criteria related to their ovarian health and PCOS diagnosis.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 38 with PCOS and a sufficient number of antral follicles.
Not a fit: Patients with severe male factor infertility or significant uterine abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to higher quality oocytes and improved pregnancy outcomes for women undergoing IVF.
How similar studies have performed: While similar approaches have shown promise, this specific use of Super-GDF9 in CAPA-IVM is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women between the ages of 18 and 38 years (both inclusive) 2. BMI ≤ 32 kg/m2 3. PCOS women according to the Rotterdam criteria (2003) 4. Indicating CAPA-IVM treatment. 5. 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 6. Willing to donate COCs for research purposes 7. Agreeing for frozen embryo 8. Signed informed consent before any study-related procedures Exclusion Criteria: 1. Known endometrioma or grade 3-4 endometriosis according to ASRM classification 2. Uterine abnormalities 3. Couples with severe male factor (sperm concentration \<5 million/ml, motility \< 10%), surgical sperm retrieval. 4. Previous history of unexplained immature oocytes after IVF treatment 5. Cycles using donor oocytes
Where this trial is running
Ho Chi Minh City
- My Duc Hospital — Ho Chi Minh City, Vietnam (RECRUITING)
Study contacts
- Principal investigator: Lan N Vuong — University of Medicine and Pharmacy at Ho Chi Minh City
- Study coordinator: Kha T Huynh
- Email: kha.ht@myduchospital.vn
- Phone: +84946699470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: In Vitro Fertilization, CAPA-IVM, super-GDF9, Culture, OSFs, PCOS