Transcriptomic Profiling of Cumulus Cells From CAPA-IVM

NCT07197255 | Recruiting

• 1 other identifier: 09/25/DD-BVMD
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

PCOS (Polycystic Ovary Syndrome); Cumulus Cell; Capacitation IVM; Transcriptomic Profiling

Keywords

In vitro maturation; CAPA-IVM; Cumulus cells; Transcriptomics

Outcome Measures

Primary Outcomes (1)

• Correlation of cumulus cell transcriptomic profiles with embryological outcomes

  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).

  Through study completion, an average of 1 year

Secondary Outcomes (8)

• CCs transcriptomic profiles

  Through study completion, an average of 1 year

• Number of matured oocyte

  At day 2 after the Oocyte Pick-Up day

• Number of normal fertilized oocytes

  16-18 hours after intracytoplasmic sperm injection

• Number of day-3 embryos

  68 ±1 hours after intra-cytoplasmic sperm injection

• Number of good-quality day-3 embryos

  68±1 hours after intra-cytoplasmic sperm injection

Study Arms (1)

PCOS Women Undergoing CAPA-IVM

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.

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with PCOS diagnosed according to the Rotterdam 2003 criteria who are indicated for CAPA-IVM treatment at IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.

You may qualify if:

• 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.

You may not qualify if:

• Retrieved sperm from surgical procedures
• Previous IVF cycle with total immature oocytes

Sponsors & Collaborators

• Mỹ Đức Hospital: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Vietnam

RECRUITING

Related Publications (9)

• Rotterdam 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 BACKGROUND

• Working 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 BACKGROUND

• Russell 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 BACKGROUND

• Assou 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 BACKGROUND

• Gebhardt 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 BACKGROUND

• Pham 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.

  PMID: 38854775 BACKGROUND

• Akin N, Richani D, Liao X, Zhao Y, Herta AC, Billooye K, Stocker WA, Mottershead DG, Harrison CA, Smitz J, Anckaert E, Gilchrist RB. Effect of cumulin and super-GDF9 in standard and biphasic mouse IVM. J Assist Reprod Genet. 2022 Jan;39(1):127-140. doi: 10.1007/s10815-021-02382-z. Epub 2022 Jan 4.

  PMID: 34984599 BACKGROUND

• Vuong LN, Ho VNA, Ho TM, Dang VQ, Phung TH, Giang NH, Le AH, Pham TD, Wang R, Smitz J, Gilchrist RB, Norman RJ, Mol BW. In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial. Hum Reprod. 2020 Nov 1;35(11):2537-2547. doi: 10.1093/humrep/deaa240.

  PMID: 32974672 BACKGROUND

• Sanchez F, Lolicato F, Romero S, De Vos M, Van Ranst H, Verheyen G, Anckaert E, Smitz JEJ. An improved IVM method for cumulus-oocyte complexes from small follicles in polycystic ovary syndrome patients enhances oocyte competence and embryo yield. Hum Reprod. 2017 Oct 1;32(10):2056-2068. doi: 10.1093/humrep/dex262.

  PMID: 28938744 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cumulus cells collected from cumulus-oocyte complexes after CAPA-IVM for transcriptomic analysis (RNA-seq).

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Lan N Vương, PhD, MD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huy H Pham, MSc.

CONTACT

+84966145510; huy.ph@myduchospital.vn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 29, 2025
• Study Start: October 16, 2025
• Primary Completion: January 30, 2026
• Study Completion: March 30, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

VN (1)