Clinical trial · Observational
Transcriptomic Profiling of Cumulus Cells From CAPA-IVM
Transcriptomic Profiling of Cumulus Cells From CAPA-IVM Cycles in Women With PCOS: A Prospective Pilot Study
NCT07197255CI-TRIAL-00097722recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Capacitation in vitro maturation (CAPA-IVM) has improved oocyte maturation and resulted in live births. Because cumulus cells (CCs) communicate bidirectionally with the oocyte, their transcriptomic profile may serve as a non-invasive biomarker of oocyte and embryo competence. This prospective pilot study will analyze CCs gene expression after CAPA-IVM using RNA sequencing and pathway analysis, and correlate findings with embryological outcomes including fertilization, day-3 cleavage, and blastocyst formation. Results are expected to provide insights into the molecular basis of oocyte competence and support development of non-invasive embryo selection strategies.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Capacitation IVM | — | UNRESOLVED | — |
| Cumulus Cell | — | UNRESOLVED | — |
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
| Transcriptomic Profiling | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- PCOS Women Undergoing CAPA-IVM
- description
- Women aged 18-38 years with PCOS (Rotterdam criteria) indicated for CAPA-IVM. From each participant, 15 cumulus-oocyte complexes (COCs) are allocated to single-culture CAPA-IVM. Cumulus cells from these COCs are collected at oocyte denudation for RNA sequencing and transcriptomic analysis.
Primary outcomes (1)
- measure
- Correlation of cumulus cell transcriptomic profiles with embryological outcomes
- timeFrame
- Through study completion, an average of 1 year
- description
- Association between cumulus cell gene expression (RNA-seq-based transcriptomic profiles) and embryological outcomes, including cleavage and embryo quality (Day 3), and blastocyst formation and grading (Days 5-6).
Secondary outcomes (8)
- measure
- CCs transcriptomic profiles
- timeFrame
- Through study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 38 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDRotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098. PMID 14688154
- BACKGROUNDWorking Group on the update of the ESHRE/ALPHA Istanbul Consensus; Coticchio G, Ahlstrom A, Arroyo G, Balaban B, Campbell A, De Los Santos MJ, Ebner T, Gardner DK, Kovacic B, Lundin K, Magli MC, Mcheik S, Morbeck DE, Rienzi L, Sfontouris I, Vermeulen N, Alikani M. The Istanbul consensus update: a revised ESHRE/ALPHA consensus on oocyte and embryo static and dynamic morphological assessmentdagger,double dagger. Hum Reprod. 2025 Jun 1;40(6):989-1035. doi: 10.1093/humrep/deaf021. PMID 40288770
- BACKGROUNDRussell DL, Gilchrist RB, Brown HM, Thompson JG. Bidirectional communication between cumulus cells and the oocyte: Old hands and new players? Theriogenology. 2016 Jul 1;86(1):62-8. doi: 10.1016/j.theriogenology.2016.04.019. Epub 2016 Apr 21. PMID 27160446
- BACKGROUNDAssou S, Haouzi D, Mahmoud K, Aouacheria A, Guillemin Y, Pantesco V, Reme T, Dechaud H, De Vos J, Hamamah S. A non-invasive test for assessing embryo potential by gene expression profiles of human cumulus cells: a proof of concept study. Mol Hum Reprod. 2008 Dec;14(12):711-9. doi: 10.1093/molehr/gan067. Epub 2008 Nov 21. PMID 19028806
- BACKGROUNDGebhardt KM, Feil DK, Dunning KR, Lane M, Russell DL. Human cumulus cell gene expression as a biomarker of pregnancy outcome after single embryo transfer. Fertil Steril. 2011 Jul;96(1):47-52.e2. doi: 10.1016/j.fertnstert.2011.04.033. Epub 2011 May 14. PMID 21575950
- BACKGROUNDPham HH, Le AH, Nguyen TC, Ma MPQ, Akin N, Pham TD, Nguyen MHN, Le HL, Huynh BG, Smitz J, Ho TM, Vuong LN. Effect of single versus grouped culture of human cumulus-oocyte complexes in PCOS women treated with biphasic in vitro maturation: A sibling oocyte pilot study. Reprod Med Biol. 2024 Jun 7;23(1):e12587. doi: 10.1002/rmb2.12587. eCollection 2024 Jan-Dec.