OSC Co-culture for Rescue IVM of Human GV Oocytes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorHung Vuong Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Conventional rescue in vitro maturation
Other interventionStandard 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-culture
Other interventionRescue 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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Conventional r-IVMActive comparator 1 intervention
Group B: r-IVM with iPSC-Derived OSC Co-cultureExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
24 hours after initiation of cultureSecondary outcomes
1
Fertilization rate
Proportion of injected oocytes showing normal fertilization with two pronuclei (2PN).
Time frame
17 to 19 hours after ICSI2
Day 3 embryo formation rate
Proportion of normally fertilized oocytes that develop to cleavage-stage embryos by day 3.
Time frame
Day 3 after fertilization3
Good-quality day 3 embryo rate
Proportion of day 3 embryos meeting predefined good-quality criteria.
Time frame
Day 3 after fertilization4
Blastocyst formation rate
Proportion of normally fertilized oocytes that develop to the blastocyst stage by day 5 or day 6.
Time frame
Day 5 to Day 6 after fertilizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hung Vuong Hospital
Lead sponsor
Dioseve Inc.
Collaborator
Source ClinicalTrials.gov
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