Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS).
Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group
https://pubmed.ncbi.nlm.nih.gov/14688154Actively Recruiting
Age: 18Years - 38Years
FEMALE
ID07197255
Transcriptomic Profiling of Cumulus Cells From CAPA-IVM Cycles in Women With PCOS: A Prospective Pilot Study
Led by Mỹ Đức Hospital · Updated on 2025-11-21
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
M
Mỹ Đức Hospital
Lead Sponsor
V
Vrije Universiteit Brussel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying women with polycystic ovary syndrome (PCOS) undergoing a special lab technique called capacitation in vitro maturation (CAPA-IVM). This technique aims to improve egg maturation and has resulted in live births. The study focuses on analyzing gene activity in cumulus cells, which surround the eggs and communicate with them. By examining these cells, the research hopes to find markers that predict egg and embryo quality to help select the best embryos in assisted reproduction. The study involves women aged 18 to 38 with PCOS who are candidates for CAPA-IVM. From each participant, 15 egg complexes are collected and placed in a single-culture CAPA-IVM process. The surrounding cumulus cells are gathered for gene analysis using RNA sequencing. The eggs are then monitored for fertilization and development through to blastocyst stage, following the center's standard CAPA-IVM protocol. Participants will have their cumulus cells analyzed for gene expression and the egg development outcomes recorded, including fertilization, embryo quality on day 3, and blastocyst formation. These data will be correlated to find potential biomarkers. The study lasts about one year to complete these assessments. This observational study does not involve additional treatments beyond the CAPA-IVM procedure.
CONDITIONS
Brief Title
Transcriptomic Profiling of Cumulus Cells From CAPA-IVM
Who Can Participate
Age: 18Years - 38Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 38 years
- Body mass index (BMI) of 32 kg/m2 or less
- Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam 2003 criteria, meeting at least two of these: oligo- or anovulation, clinical or biochemical signs of hyperandrogenism, or polycystic ovarian morphology on ultrasound
- Indicated for CAPA-IVM treatment
- Serum anti-Mullerian hormone (AMH) level of 4 ng/mL or higher
- Antral follicle count (AFC) of 24 or more follicles in both ovaries at CAPA-IVM indication
- Signed informed consent to participate in the study
You will not qualify if you...
- Use of sperm retrieved from surgical procedures
- Previous IVF cycle with all retrieved oocytes immature
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Observational CAPA-IVM Cycle
Duration - Up to 1 week
Participants undergo the CAPA-IVM cycle where cumulus-oocyte complexes are collected for transcriptomic analysis and oocytes are assessed for embryological outcomes.
1 oocyte retrieval visit and embryo assessment visits on days 2, 3, 5, and 6 after retrieval
Long-term Monitoring
Duration - Through study completion, an average of 1 year
Participants are monitored over approximately 1 year for correlation of cumulus cell transcriptomic profiles with embryological outcomes.
Follow-up assessments as per clinical routine
Trial Site Locations
Total: 1 location
1
My Duc Hospital
Ho Chi Minh City, Vietnam
Actively Recruiting
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Research Team
H
Huy H Pham, MSc.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
The Istanbul consensus update: a revised ESHRE/ALPHA consensus on oocyte and embryo static and dynamic morphological assessment†,‡.
Working Group on the update of the ESHRE/ALPHA Istanbul Consensus, Giovanni Coticchio, Aisling Ahlström...
https://pubmed.ncbi.nlm.nih.gov/40288770Bidirectional communication between cumulus cells and the oocyte: Old hands and new players?
Darryl L Russell, Robert B Gilchrist, Hannah M Brown...
https://pubmed.ncbi.nlm.nih.gov/27160446A non-invasive test for assessing embryo potential by gene expression profiles of human cumulus cells: a proof of concept study.
S Assou, D Haouzi, K Mahmoud...
https://pubmed.ncbi.nlm.nih.gov/19028806Human cumulus cell gene expression as a biomarker of pregnancy outcome after single embryo transfer.
Kathryn Michelle Gebhardt, Deanne Kate Feil, Kylie Renee Dunning...
https://pubmed.ncbi.nlm.nih.gov/21575950Effect of single versus grouped culture of human cumulus-oocyte complexes in PCOS women treated with biphasic in vitro maturation: A sibling oocyte pilot study.
Huy H Pham, Anh H Le, Tri C Nguyen...
https://pubmed.ncbi.nlm.nih.gov/38854775Effect of cumulin and super-GDF9 in standard and biphasic mouse IVM.
Nazli Akin, Dulama Richani, Xiuhua Liao...
https://pubmed.ncbi.nlm.nih.gov/34984599In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial.
Lan N Vuong, Vu N A Ho, Tuong M Ho...
https://pubmed.ncbi.nlm.nih.gov/32974672An improved IVM method for cumulus-oocyte complexes from small follicles in polycystic ovary syndrome patients enhances oocyte competence and embryo yield.
F Sánchez, F Lolicato, S Romero...
https://pubmed.ncbi.nlm.nih.gov/28938744