OSC Co-culture for Rescue IVM of Human GV Oocytes (OSC-rIVM)

April 23, 2026 updated by: Thi Thanh Thuy Tran, MD, Hung Vuong Hospital

Effect of iPSC-Derived Ovarian Support Cell Co-culture on Rescue In Vitro Maturation of Human Germinal Vesicle Oocytes: A Randomized Sibling-Oocyte Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Immature human oocytes at the germinal vesicle (GV) stage retrieved during routine IVF cycles are usually not used in standard clinical treatment. Rescue in vitro maturation (r-IVM) offers a potential strategy to increase the number of mature oocytes available for laboratory use, but maturation outcomes for GV oocytes remain limited. This study investigates whether co-culture with iPSC-derived ovarian support cells (OSCs) can improve the biological performance of r-IVM in surplus GV oocytes.

This is a single-center, randomized, sibling-oocyte controlled study conducted at the Infertility Department of Hung Vuong Hospital, Ho Chi Minh City, Vietnam. Women undergoing routine IVF who have at least two eligible GV oocytes in one retrieval cycle may participate after providing informed consent. Within each participant, eligible GV oocytes are allocated in a 1:1 ratio to either conventional r-IVM in CSCMC medium or r-IVM in CSCMC medium with iPSC-derived OSC co-culture.

Allocation is performed separately within each participant using a manual lottery-based randomization procedure. If an odd number of eligible GV oocytes is available, one oocyte is randomly excluded before allocation to preserve equal within-participant assignment. Oocytes in both groups are cultured under identical laboratory conditions; the only difference between groups is the presence of OSCs in the intervention arm. Matured oocytes are assessed after 24 hours. Oocytes reaching MII undergo ICSI, and fertilized oocytes are cultured to day 5-6 in a time-lapse system. Embryo development is evaluated using standard morphology criteria with independent assessment and time-lapse support.

The study is designed to compare biological outcomes between conventional r-IVM and OSC-supported r-IVM while minimizing between-patient confounding through within-participant allocation. The participant is treated as the clustering unit for statistical analysis.

This section is taken from the protocol's rationale, procedures, randomization logic, and outcome plan.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional r-IVM
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
Standard rescue in vitro maturation of denuded germinal vesicle oocytes in CSCMC culture medium for 24 hours under routine IVF laboratory conditions.
Experimental: r-IVM with iPSC-Derived OSC Co-culture
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MII maturation rate after 24 hours of culture
Time Frame: 24 hours after initiation 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: 17 to 19 hours after ICSI
Proportion of injected oocytes showing normal fertilization with two pronuclei (2PN).
17 to 19 hours after ICSI
Day 3 embryo formation rate
Time Frame: Day 3 after fertilization
Proportion of normally fertilized oocytes that develop to cleavage-stage embryos by day 3.
Day 3 after fertilization
Good-quality day 3 embryo rate
Time Frame: Day 3 after fertilization
Proportion of day 3 embryos meeting predefined good-quality criteria.
Day 3 after fertilization
Blastocyst formation rate
Time Frame: Day 5 to Day 6 after fertilization
Proportion of normally fertilized oocytes that develop to the blastocyst stage by day 5 or day 6.
Day 5 to Day 6 after fertilization
Good-quality blastocyst rate
Time Frame: Day 5 to Day 6 after fertilization
Proportion of blastocysts meeting predefined good-quality criteria.
Day 5 to Day 6 after fertilization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hung Vuong Hospital

Collaborators

Dioseve Inc.

Investigators

  • Principal Investigator: Tuyet Thi-Diem Hoang, MD, Hung Vuong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS/HV/26/04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make individual participant data available to other researchers at the time of registration. This matches the conservative choice we discussed for a sensitive embryo/oocyte dataset without a formal external-sharing framework.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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