- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Descrizione dettagliata
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.).
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Sophie BROUILLET, MCU-PH
- Numero di telefono: 33 .4.67.33.59.54
- Email: s-brouillet@chu-montpellier.fr
Backup dei contatti dello studio
- Nome: Fatima BARRY, AHU
- Numero di telefono: 33 4.67.33.64.04
- Email: fatima.barry@chu-montpellier.fr
Luoghi di studio
-
-
-
Montpellier, Francia, 34295
- Reclutamento
- UHMontpellier
-
Contatto:
- Sophie BROUILLET, MD
- Numero di telefono: 33 4.67.33.59.54
- Email: s-brouillet@chu-montpellier.fr
-
Contatto:
- Fatima BARRY, AHU
- Numero di telefono: 33 .4.67.33.64.04
- Email: fatima.barry@chu-montpellier.fr
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Rate of research in preimplantation embryo development in vitro
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Rate of Identification of new non-invasive biomarkers
Lasso di tempo: 1 day
|
Identification of new non-invasive biomarkers which are predictive for preimplantation embryo development and pregnancy
|
1 day
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Samir HAMAMAH, PUPH, University Hospital, Montpellier
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RECHMPL22_0069
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .