Gene profiling of cumulus cells after CAPA‑IVM
Transcriptomic Profiling of Cumulus Cells From CAPA-IVM Cycles in Women With PCOS: A Prospective Pilot Study
This pilot will test whether gene patterns in cumulus cells collected after CAPA‑IVM can help predict egg and embryo quality for women with PCOS undergoing CAPA‑IVM.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | Mỹ Đức Hospital Academic / other |
| Locations | 1 site (Ho Chi Minh City) |
| Trial ID | NCT07197255 on ClinicalTrials.gov |
What this trial studies
This prospective observational cohort at My Duc Hospital will enroll women with PCOS undergoing CAPA‑IVM and collect cumulus cells from individual cumulus–oocyte complexes following a single‑culture CAPA‑IVM protocol. RNA sequencing will be performed using low‑input methods and analyzed with differential expression tools (DESeq2) and pathway analyses such as Gene Ontology and Ingenuity. The molecular profiles of cumulus cells will be correlated with embryology outcomes including fertilization, day‑3 cleavage, and blastocyst formation. The study aims to identify transcriptomic signatures that could serve as non‑invasive biomarkers of oocyte competence to inform embryo selection.
Who should consider this trial
Good fit: Women aged 18–38 with PCOS by Rotterdam criteria, BMI ≤32 kg/m2, AMH ≥4 ng/mL and AFC ≥24 who are scheduled for CAPA‑IVM are ideal candidates.
Not a fit: Women without PCOS, with low ovarian reserve (AMH <4 ng/mL or AFC <24), those using surgically retrieved sperm, or those not undergoing CAPA‑IVM are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could provide a non‑invasive biomarker from cumulus cells to help select the best oocytes and embryos and potentially improve IVF success for women with PCOS.
How similar studies have performed: CAPA‑IVM has been linked to improved oocyte maturation and live births, and prior studies have shown correlations between cumulus cell gene expression and oocyte quality, but reliable transcriptomic predictors of embryo outcomes are still preliminary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women 18-38 years * BMI =\< 32kg/m2 * Diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam 2003 criteria, meet at least 2 of the following 3 features: (1) Oligo-ovulation or anovulation. (2) Clinical and/or biochemical signs of hyperandrogenism (3) Polycystic ovarian morphology on ultrasound. * Indicated for CAPA-IVM treatment. * Serum AMH ≥ 4 ng/mL (28.57 pmol/L). * Antral follicle count (AFC) ≥ 24 follicles in both ovaries at the time of CAPA-IVM indication. * Signed informed consent to participate in the study. Exclusion Criteria: * Retrieved sperm from surgical procedures * Previous IVF cycle with total immature 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 Vương, PhD, MD — University of Medicine and Pharmacy at Ho Chi Minh City
- Study coordinator: Huy H Pham, MSc.
- Email: huy.ph@myduchospital.vn
- Phone: +84966145510
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.