- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Detaljeret beskrivelse
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.).
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Sophie BROUILLET, MCU-PH
- Telefonnummer: 33 .4.67.33.59.54
- E-mail: s-brouillet@chu-montpellier.fr
Undersøgelse Kontakt Backup
- Navn: Fatima BARRY, AHU
- Telefonnummer: 33 4.67.33.64.04
- E-mail: fatima.barry@chu-montpellier.fr
Studiesteder
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Montpellier, Frankrig, 34295
- Rekruttering
- Uhmontpellier
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Kontakt:
- Sophie BROUILLET, MD
- Telefonnummer: 33 4.67.33.59.54
- E-mail: s-brouillet@chu-montpellier.fr
-
Kontakt:
- Fatima BARRY, AHU
- Telefonnummer: 33 .4.67.33.64.04
- E-mail: fatima.barry@chu-montpellier.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of research in preimplantation embryo development in vitro
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of Identification of new non-invasive biomarkers
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Samir HAMAMAH, PUPH, University Hospital, Montpellier
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RECHMPL22_0069
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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