OSC Co-culture for Rescue IVM of Human GV Oocytes (OSC-rIVM)
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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Huy Phuong Tran, PhD
- 전화번호: +84 896 416 098
- 이메일: tranphuonghuy1994@gmail.com
연구 장소
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Ho Chi Minh City, 베트남, 700000
- Infertility Department
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연락하다:
- Huy Phuong Tran, PhD
- 전화번호: +84 896 416 098
- 이메일: tranphuonghuy1994@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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Standard rescue in vitro maturation of denuded germinal vesicle oocytes in CSCMC culture medium for 24 hours under routine IVF laboratory conditions.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MII maturation rate after 24 hours of culture
기간: 24 hours after initiation of culture
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Proportion of cultured GV oocytes that reach metaphase II (MII) after 24 hours of rescue in vitro maturation.
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24 hours after initiation of culture
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fertilization rate
기간: 17 to 19 hours after ICSI
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Proportion of injected oocytes showing normal fertilization with two pronuclei (2PN).
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17 to 19 hours after ICSI
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Day 3 embryo formation rate
기간: Day 3 after fertilization
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Proportion of normally fertilized oocytes that develop to cleavage-stage embryos by day 3.
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Day 3 after fertilization
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Good-quality day 3 embryo rate
기간: Day 3 after fertilization
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Proportion of day 3 embryos meeting predefined good-quality criteria.
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Day 3 after fertilization
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Blastocyst formation rate
기간: Day 5 to Day 6 after fertilization
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Proportion of normally fertilized oocytes that develop to the blastocyst stage by day 5 or day 6.
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Day 5 to Day 6 after fertilization
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Good-quality blastocyst rate
기간: Day 5 to Day 6 after fertilization
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Proportion of blastocysts meeting predefined good-quality criteria.
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Day 5 to Day 6 after fertilization
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CS/HV/26/04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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