Modelization of Early Endometrial-trophoblast Molecular Interaction (MEETMI)
연구 개요
상세 설명
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 .
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Camille Jung, Pr
- 전화번호: 01 57 02 31 15
- 이메일: crcpromotion@chicreteil.fr
연구 장소
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Créteil, 프랑스, 94000
- Chi Creteil
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연락하다:
- Edouard Lecarpentier, Pr
- 전화번호: 0157023235
- 이메일: Edouard.Lecarpentier@chicreteil.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Determine transcriptionnal and proteic signatures of endometrial-trophoblast
기간: Day 20
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Determine transcriptionnal and proteic signatures of endometrial-trophoblast
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Day 20
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Placental Penetration into the extracellular matrix
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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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
추가 관련 MeSH 약관
기타 연구 ID 번호
- MEETMI
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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