Oocyte MaturationOSC-rIVMNCT07559357
OSC Co-culture for Rescue IVM of Human GV Oocytes
A study testing Conventional rescue in vitro maturation and Rescue in vitro maturation with iPSC-derived ovarian support cell co-culture in people with Oocyte Maturation and Infertility, run by Hung Vuong Hospital at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Oocyte Maturation, Infertility
- What is being tested?
- Conventional rescue in vitro maturation and Rescue in vitro maturation with iPSC-derived ovarian support cell co-culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteVietnam
- Study dates
- Jun 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Infertility Department
Ho Chi Minh City, 700000
Huy Phuong Tran, PhD, +84 896 416 098, tranphuonghuy1994@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Oocyte Maturation, Infertility
- Being tested
- Conventional rescue in vitro maturation, Rescue in vitro maturation with iPSC-derived ovarian support cell co-culture
- Keywords
- Rescue in vitro maturation, r-IVM, Germinal vesicle oocyte, iPSC-derived ovarian support cells, OSC co-culture, Embryo development, IVF, Sibling-oocyte trial
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional rescue in vitro maturationOther
Standard rescue in vitro maturation of denuded germinal vesicle oocytes in CSCMC culture medium for 24 hours under routine IVF laboratory conditions.
Rescue in vitro maturation with iPSC-derived ovarian support cell co-cultureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Rescue in vitro maturation with iPSC-derived ovarian support cell co-culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after initiation of culture
Secondary outcomes (5)
Fertilization rate
Proportion of injected oocytes showing normal fertilization with two pronuclei (2PN).
Measured: 17 to 19 hours after ICSI
Day 3 embryo formation rate
Proportion of normally fertilized oocytes that develop to cleavage-stage embryos by day 3.
Measured: Day 3 after fertilization
Good-quality day 3 embryo rate
Proportion of day 3 embryos meeting predefined good-quality criteria.
Measured: Day 3 after fertilization
Blastocyst formation rate
Proportion of normally fertilized oocytes that develop to the blastocyst stage by day 5 or day 6.
Measured: Day 5 to Day 6 after fertilization
Good-quality blastocyst rate
Proportion of blastocysts meeting predefined good-quality criteria.
Measured: Day 5 to Day 6 after fertilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte MaturationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hung Vuong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dioseve Inc.
- Responsible party
- Principal investigator, Thi Thanh Thuy Tran, MD, Hung Vuong Hospital
- Investigators
- Tuyet Thi-Diem Hoang, MD, Principal investigator, Hung Vuong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559357
- Sponsor's protocol ID
- CS/HV/26/04
- Acronym
- OSC-rIVM
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07559357
- Acronym / sponsor ID
- OSC-rIVM / CS/HV/26/04
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hung Vuong HospitalUniversity, hospital or other
- Collaborators
- Dioseve Inc.
- Study start
- Jun 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional r-IVM | Active comparator | Other: Conventional rescue in vitro maturationEligible GV oocytes are cultured for 24 hours in standard CSCMC medium under routine rescue in vitro maturation conditions without ovarian support cell co-culture. |
| r-IVM with iPSC-Derived OSC Co-culture | Experimental | Other: Rescue in vitro maturation with iPSC-derived ovarian support cell co-cultureEligible GV oocytes are cultured for 24 hours in CSCMC medium with co-culture using iPSC-derived ovarian support cells prepared according to laboratory SOPs. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional rescue in vitro maturationStandard rescue in vitro maturation of denuded germinal vesicle oocytes in CSCMC culture medium for 24 hours under routine IVF laboratory conditions. | Other | Conventional r-IVM |
| Rescue in vitro maturation with iPSC-derived ovarian support cell co-cultureRescue 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. | Other | r-IVM with iPSC-Derived OSC Co-culture |
Primary outcome
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.
5 secondary outcomes
Fertilization rate
Time frame: 17 to 19 hours after ICSI
Day 3 embryo formation rate
Time frame: Day 3 after fertilization
Good-quality day 3 embryo rate
Time frame: Day 3 after fertilization
Blastocyst formation rate
Time frame: Day 5 to Day 6 after fertilization
Good-quality blastocyst rate
Time frame: Day 5 to Day 6 after fertilization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tuyet Thi-Diem Hoang, MD principal investigator
Hung Vuong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional rescue in vitro maturation and Rescue in vitro maturation with iPSC-derived ovarian support cell co-culture in people with Oocyte Maturation and Infertility, run by Hung Vuong Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huy Phuong Tran, PhD (+84 896 416 098, tranphuonghuy1994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MII maturation rate after 24 hours of culture (time frame: 24 hours after initiation of culture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.