Transcriptomic Profiling of Cumulus Cells From CAPA-IVM

NCT ID: NCT07197255

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-16
• Study Completion Date: 2026-03-30

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.

Detailed Description

In vitro maturation (IVM) is an alternative to conventional ovarian stimulation, particularly for women with polycystic ovary syndrome (PCOS) or at risk of ovarian hyperstimulation syndrome (OHSS). A novel technique, known as capacitation IVM (CAPA-IVM), introduces a pre-maturation step that improves both nuclear and cytoplasmic maturation and has been associated with live births. Cumulus-oocyte complexes (COCs) represent the functional unit of oocyte competence, with cumulus cells (CCs) providing bidirectional signaling that regulates oocyte development. Because CCs are routinely removed during ICSI, they serve as a readily accessible and non-invasive source of information about oocyte and embryo potential.

This prospective observational cohort study will be conducted at the IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam. Eligible participants are women diagnosed with PCOS according to the Rotterdam 2003 criteria, with serum AMH ≥ 4 ng/mL and antral follicle count (AFC) ≥ 24, indicated for CAPA-IVM treatment. From each participant, 15 COCs will be allocated to single-culture CAPA-IVM condition. CCs from each COC will be collected for transcriptomic analysis, while the oocytes are assessed for embryological outcomes. The remaining COCs will follow the standard CAPA-IVM protocol at the center.

RNA sequencing will be performed using low-input protocols. Data will undergo differential expression analysis (DESeq2), and functional interpretation using Gene Ontology and Ingenuity Pathway Analysis. Laboratory outcomes including day-3 cleavage, and blastocyst formation will be correlated with CC transcriptomic profiles. This study aims to identify non-invasive biomarkers of oocyte and embryo competence, supporting future embryo selection strategies in assisted reproduction. By correlating cumulus cell transcriptomic profiles with oocyte and embryo outcomes, this study seeks to establish preliminary non-invasive biomarkers for embryo selection in assisted reproduction.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

Mỹ Đức Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lan N Vương, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Pharmacy at Ho Chi Minh City

Locations

My Duc Hospital

Ho Chi Minh City, , Vietnam

Site Status: RECRUITING

Countries

Vietnam

Central Contacts

Huy H Pham, MSc.

Role: CONTACT

huy.ph@myduchospital.vn

+84966145510

Facility Contacts

Tuong M Ho, MD

Role: primary

tuongho.ivfmd@gmail.com

+84903633377

Lan N Vuong, MD, PhD

Role: backup

drlan@yahoo.com.vn

+84903008889

References

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Other Identifiers

09/25/DD-BVMD

Identifier Type: -

Identifier Source: org_study_id