- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05231551
Using Embryo Organoids to Discover Human-specific Mechanisms of Preimplantation Embryo Development and Early Pregnancy (EMBRYOx)
Using Embryo Organoids (i.e. Embryoids) to Discover Human-specific Mechanisms of Preimplantation Embryo Development and Early Pregnancy
연구 개요
상세 설명
Study objectives:
Our primary objective is to compare the transcriptomic profiles of embryoids with those obtained from human embryos donated to research and cultured in two different oxygen conditions (monophasic oxygen strategy: 5% of O2 for 5 days vs. biphasic oxygen strategy: 5% of O2 for 3 days and 2% of O2 afterwards for 2 days). The transcriptomic profiles of human embryos donated to research and cultured in two different oxygen conditions were obtained in our previous study (PMID: 34789773). The biphasic oxygen strategy turned out to be beneficial for early embryo development and pregnancy. The comparison of transcriptomic profiles could allow us to validate the embryoids as a model in the study of preimplantation embryo development in vitro. Moreover, this could permit us to better understand the molecular mechanisms associated with the positive impact of the biphasic oxygen conditions on embryo development.
Our secondary objective is to identify new non-invasive biomarkers predictive for preimplantation embryo development and pregnancy.
This is a prospective, monocentric, observational study.
Study population:
Patients having first trimester voluntary termination of pregnancy in Montpellier University Hospital which have previously signed an informed consent. Placental tissues are collected after aspiration of abortion products. At least 5 organoids populations from 5 different placentas will be generated.
Material and methods:
- Collection of placental tissues after first trimester voluntary termination of pregnancy. Foetal tissues will not be collected as organoids are formed exclusively of trophoblast placental stem cells.
- Isolation of trophoblast placental stem cells.
- Culture, differentiation, and formation of embryoids.
- Culture of embryoids under monophasic (5% of O2 for 5 days) or biphasic oxygen conditions (5% of O2 for 3 days and 2% of O2 after for 2 days).
- ARN extraction (MiniKit Qiagen) and establishment of transcriptomic profiles (MGX-Montpellier GenomiX platform).
- Comparison of the transcriptomic profiles obtained with those of human embryos (Ingenuity Pathway Analysis).
- Cryopreservation of extra organoids in liquid nitrogen.
Assessment criteria:
Embryoids' dimension (100-150 um), proliferation/apoptosis index, expression of trophoblast markers (GATA3, KRT7, EGFR, TFAP2A, TFAP2C) by qPCR (Affymetrix Clariom) or immunohistochemistry.
Results and perspectives:
The investigators are expecting to obtain higher expression of proliferation, cellular survivor and pluripotency genes in embryoids cultured in biphasic oxygen conditions. If the investigators find the same outcomes after transcriptomic analysis of trophoblast organoids as those of human embryos, this would support the utilisation of organoids as a model in the study of human preimplantation embryo development.
Subsequently, the investigators could test the impact of other factors on the organoids' development (as culture medium composition, pH, etc.) and optimise the predictive value of non-invasive biomarkers (cf-DNA, PROK1 etc.).
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Sophie BROUILLET, MCU-PH
- 전화번호: 33 .4.67.33.59.54
- 이메일: s-brouillet@chu-montpellier.fr
연구 연락처 백업
- 이름: Fatima BARRY, AHU
- 전화번호: 33 4.67.33.64.04
- 이메일: fatima.barry@chu-montpellier.fr
연구 장소
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Montpellier, 프랑스, 34295
- 모병
- UHMontpellier
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연락하다:
- Sophie BROUILLET, MD
- 전화번호: 33 4.67.33.59.54
- 이메일: s-brouillet@chu-montpellier.fr
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연락하다:
- Fatima BARRY, AHU
- 전화번호: 33 .4.67.33.64.04
- 이메일: fatima.barry@chu-montpellier.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion criteria:
- No smoking patients without drug consumption or previous medication who are having first trimester voluntary termination of pregnancy surgically or medically induced.
Exclusion criteria:
- Patients smoking, drug consumption, previous medication
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Single-group study
Patients having first trimester voluntary termination of pregnancy in Montpellier university hospital.
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Placental tissues are collected after aspiration of abortion products.
They are treated immediately in order to isolate placental stem cells.
Organoid culture is established and the obtained embryoids are cultured in monophasic or biphasic oxygen conditions.
Extra organoids are cryopreserved in liquid nitrogen
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Rate of research in preimplantation embryo development in vitro
기간: 1 day
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Establish and validate the use of embryoids from trophoblast placental stem cells as a 3D model for research in preimplantation embryo development in vitro.Our primary objective is to compare the transcriptomic profiles of embryoids with those obtained from human embryos donated to research and cultured in two different oxygen conditions (monophasic oxygen strategy: 5% of O2 for 5 days vs. biphasic oxygen strategy: 5% of O2 for 3 days and 2% of O2 afterwards for 2 days).
The transcriptomic profiles of human embryos donated to research and cultured in two different oxygen conditions were obtained in our previous study (PMID: 34789773).
The biphasic oxygen strategy turned out to be beneficial for early embryo development and pregnancy.
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1 day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Rate of Identification of new non-invasive biomarkers
기간: 1 day
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Identification of new non-invasive biomarkers which are predictive for preimplantation embryo development and pregnancy
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1 day
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공동 작업자 및 조사자
수사관
- 연구 책임자: Samir HAMAMAH, PUPH, University Hospital, Montpellier
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Placental tissues에 대한 임상 시험
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Instituto Fernandes FigueiraHospital de Clinicas de Porto Alegre; University of Campinas, Brazil; UPECLIN HC FM Botucatu... 그리고 다른 협력자들완전한