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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Huy Phuong Tran, PhD
- 電話番号：+84 896 416 098
- メール：tranphuonghuy1994@gmail.com
研究場所
-
-
-
Ho Chi Minh City、ベトナム、700000
- Infertility Department
-
コンタクト：
- Huy Phuong Tran, PhD
- 電話番号：+84 896 416 098
- メール：tranphuonghuy1994@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
Standard rescue in vitro maturation of denuded germinal vesicle oocytes in CSCMC culture medium for 24 hours under routine IVF laboratory conditions.
|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
MII maturation rate after 24 hours of culture
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fertilization rate
時間枠：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
時間枠：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
時間枠：Day 3 after fertilization
|
Proportion of day 3 embryos meeting predefined good-quality criteria.
|
Day 3 after fertilization
|
|
Blastocyst formation rate
時間枠：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
時間枠：Day 5 to Day 6 after fertilization
|
Proportion of blastocysts meeting predefined good-quality criteria.
|
Day 5 to Day 6 after fertilization
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CS/HV/26/04
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。