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Using Embryo Organoids to Discover Human-specific Mechanisms of Preimplantation Embryo Development and Early Pregnancy (EMBRYOx)

10. februar 2022 opdateret af: University Hospital, Montpellier

Using Embryo Organoids (i.e. Embryoids) to Discover Human-specific Mechanisms of Preimplantation Embryo Development and Early Pregnancy

EMBRYOx study aims to establish and validate the use of trophoblast organoids (embryoids) from trophoblast placental stem cells as a 3D research model in understanding further preimplantation embryo development in vitro. The organoids are capable of proliferation, differentiation, and implantation in a matrix, reproducing early human embryo development.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

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

Observationel

Tilmelding (Forventet)

5

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Single-group study
Patients having first trimester voluntary termination of pregnancy in Montpellier university hospital.
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of research in preimplantation embryo development in vitro
Tidsramme: 1 day
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.
1 day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Identification of new non-invasive biomarkers
Tidsramme: 1 day
Identification of new non-invasive biomarkers which are predictive for preimplantation embryo development and pregnancy
1 day

Samarbejdspartnere og efterforskere

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Efterforskere

  • Studieleder: Samir HAMAMAH, PUPH, University Hospital, Montpellier

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2022

Primær færdiggørelse (Forventet)

1. februar 2024

Studieafslutning (Forventet)

28. februar 2024

Datoer for studieregistrering

Først indsendt

7. februar 2022

Først indsendt, der opfyldte QC-kriterier

7. februar 2022

Først opslået (Faktiske)

9. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RECHMPL22_0069

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

NC

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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