Modelization of Early Endometrial-trophoblast Molecular Interaction (MEETMI)
調査の概要
詳細な説明
Despite significant advances in assisted reproductive technology, only 25% of in vitro fertilization (IVF) embryo transfers result in pregnancy, largely due to implantation failure.
Preeclampsia complicates 2 to 5% of pregnancies, causes 76,000 maternal deaths worldwide each year, and is one of the leading causes of extreme prematurity (20% of premature births occurring before 32 weeks of gestation). There is no curative treatment, and only delivery of the baby and placenta can cure the patient. During preeclampsia, early placental abnormalities occur in the first trimester of pregnancy, even though the initial stages of human embryo implantation (apposition, adhesion, invasion) and early placentation remain poorly understood.
The primary objective of the MEETMI project is to characterize, in the laboratory, the early endometrium-trophoblast molecular interactions that determine the initial stages of human implantation and placentation.
It is essential to collect human endometrial cells (epithelial and stromal cells) from endometrial biopsies performed as part of routine care in patients who have been previously informed and have given their consent to the research.
For the placental part, following models available in the Lecarpentier's laboratory at the Institut Cochin will be used: human trophoblast stem cells (hTSCs), placental organoids derived from first-trimester placenta .
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：Camille Jung, Pr
- 電話番号：01 57 02 31 15
- メール：crcpromotion@chicreteil.fr
研究場所
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Créteil、フランス、94000
- Chi Creteil
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コンタクト：
- Edouard Lecarpentier, Pr
- 電話番号：0157023235
- メール：Edouard.Lecarpentier@chicreteil.fr
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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:
- Medical indication for a diagnostic hysteroscopy between the ages of 18 and 50
- Comprehensive information provided prior to the hysteroscopy
- Informed consent signed by the patient
Exclusion Criteria:
- Current pregnancy
- Age < 18 or > 50
- Patient refusal
- Woman under court-ordered protection
- Not enrolled in the general social security system
- Patient who is HIV- or HCV-positive, regardless of viral load
- Patient whose medical history requires medication that may interfere with trophoblast biology (immunomodulators in cases of autoimmune diseases, anti-rejection drugs in transplant patients)
- Known genetic disorder in the patient
- Unable to understand and sign the consent form
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Hysteroscopy arm
Patients will undergo a diagnostic hysteroscopy during which a endometrial biopsy may be performed.
An additional extended endometrial biopsy will be collected for research purposes.
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During the gynecological consultation prior to the diagnostic hysteroscopy, patients who meet the inclusion criteria will be offered participation in the MEETMI study. The patient's consent will be obtained during this consultation or no later than the day of the hysteroscopy. The hysteroscopy will preferably be performed on days 14-16 of the menstrual cycle, outside the menstrual period, in accordance with current practices. During this hysteroscopy:
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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 |
|---|---|---|
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Determine transcriptionnal and proteic signatures of endometrial-trophoblast
時間枠：Day 20
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Determine transcriptionnal and proteic signatures of endometrial-trophoblast
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Day 20
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Placental Penetration into the extracellular matrix
時間枠：Day 20
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Quantity of placental penetrating cells will be measured using fluorescent confocal microscopy on live cells and fixed (formol 4%) slices (depth, cells proportion). Placental cells will be labelled using specific antibodies (syncytin, hCG). |
Day 20
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Viability of the co-culture
時間枠：Day 20
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LDH assay for Viability of the blastoid/organoid/gastruloidco-culture viability.
Viability will be assessed in the cells supernatant dosing Lactate Deshydrogenase (LDH).
LDH is a commonly used method for determining cell viability and cell cytotoxicity following cell damage or death, such as by necrosis, apoptosis, and other forms of cell and tissue damage.
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Day 20
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Development of syncytiotrophoblast: To vizualise syncytiotrophoblast development: hCG concentration in co-culture supernatant
時間枠：Day 20
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To vizualise syncytiotrophoblast development, investigators will quantify hCG secretion on the co-culture supernatant.
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Day 20
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Development of syncytiotrophoblast: sFLT1 concentration in co-culture supernatant
時間枠：Day 20
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Investigators will also measure angiogenic factors in the supernantant (sFLT1)
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Day 20
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Development of syncytiotrophoblast: PlGF concentration in co-culture supernatant
時間枠：Day 20
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PlGF concentration will be measured in the co-culture supernatant.
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Day 20
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Development of syncytiotrophoblast: Fusion index
時間枠：Day 20
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Investigators will quantify fusion by calculating fusion index on fixed slices (formol 4%)
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Day 20
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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
追加の関連 MeSH 用語
その他の研究ID番号
- MEETMI
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?
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
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