OSC Co-culture for Rescue IVM of Human GV Oocytes

NCT07559357 | Not Yet Recruiting

• 1 other identifier: CS/HV/26/04
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center randomized sibling-oocyte controlled trial evaluates whether co-culture with induced pluripotent stem cell (iPSC)-derived ovarian support cells (OSCs) improves rescue in vitro maturation (r-IVM) outcomes of surplus germinal vesicle (GV) oocytes collected during routine IVF treatment. Eligible GV oocytes from each enrolled participant are allocated within participant in a 1:1 ratio to either conventional r-IVM or r-IVM with OSC co-culture. The primary outcome is the metaphase II (MII) maturation rate after 24 hours of culture. Secondary outcomes include fertilization rate, day 3 embryo formation, good-quality day 3 embryo rate, blastocyst formation, and good-quality blastocyst rate. All embryos generated in the study are for research purposes only and will not be used for clinical embryo transfer.

Conditions

Oocyte Maturation; Infertility

Keywords

Rescue in vitro maturation; r-IVM; Germinal vesicle oocyte; iPSC-derived ovarian support cells; OSC co-culture; Embryo development; IVF; Sibling-oocyte trial

Outcome Measures

Primary Outcomes (1)

• MII maturation rate after 24 hours of culture

  Proportion of cultured GV oocytes that reach metaphase II (MII) after 24 hours of rescue in vitro maturation.

  24 hours after initiation of culture

Secondary Outcomes (5)

• Fertilization rate

  17 to 19 hours after ICSI

• Day 3 embryo formation rate

  Day 3 after fertilization

• Good-quality day 3 embryo rate

  Day 3 after fertilization

• Blastocyst formation rate

  Day 5 to Day 6 after fertilization

• Good-quality blastocyst rate

  Day 5 to Day 6 after fertilization

Study Arms (2)

Conventional r-IVM

ACTIVE COMPARATOR

Eligible GV oocytes are cultured for 24 hours in standard CSCMC medium under routine rescue in vitro maturation conditions without ovarian support cell co-culture.

Other: Conventional rescue in vitro maturation

r-IVM with iPSC-Derived OSC Co-culture

EXPERIMENTAL

Eligible GV oocytes are cultured for 24 hours in CSCMC medium with co-culture using iPSC-derived ovarian support cells prepared according to laboratory SOPs.

Other: Rescue in vitro maturation with iPSC-derived ovarian support cell co-culture

Interventions

Conventional rescue in vitro maturation OTHER

Standard rescue in vitro maturation of denuded germinal vesicle oocytes in CSCMC culture medium for 24 hours under routine IVF laboratory conditions.

Conventional r-IVM

Rescue in vitro maturation with iPSC-derived ovarian support cell co-culture OTHER

Rescue in vitro maturation of denuded germinal vesicle oocytes in CSCMC culture medium for 24 hours with co-culture using iPSC-derived ovarian support cells supplied by Dioseve Inc. and prepared according to the laboratory SOP.

r-IVM with iPSC-Derived OSC Co-culture

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 45 years.
• At least 2 GV oocytes retrieved in a single oocyte retrieval cycle.
• Voluntary informed consent from the couple to participate in the study.
• Agreement that all embryos generated from the study will be used for research purposes only and will not be transferred for clinical treatment.

You may not qualify if:

• Sperm obtained through surgical retrieval procedures, including PESA, MESA, TESE, or micro-TESE.
• Use of donor gametes, including donor oocytes or donor sperm.
• Participants with GV oocytes showing obvious morphological abnormalities, such as degeneration, severe deformation, or marked cytoplasmic abnormalities.

Sponsors & Collaborators

• Hung Vuong Hospital: lead
• Dioseve Inc.: collaborator

Study Sites (1)

Infertility Department

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Tuyet Thi-Diem Hoang, MD

  Hung Vuong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huy Phuong Tran, PhD

CONTACT

+84 896 416 098; tranphuonghuy1994@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Embryologists performing culture procedures cannot be blinded because the presence or absence of OSC co-culture is evident during laboratory handling. However, outcome assessment is performed independently by embryologists who are not involved in allocation and who assess recoded masked identifiers.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Within each enrolled participant, eligible GV oocytes are allocated in a 1:1 ratio to conventional rescue in vitro maturation (r-IVM) or r-IVM with iPSC-derived ovarian support cell (OSC) co-culture. Allocation is performed separately within each participant using a manual lottery-based randomization procedure. When an odd number of eligible GV oocytes is available, one oocyte is randomly excluded before allocation to preserve equal within-participant assignment. The participant is treated as the clustering unit in statistical analyses.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)