- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Detaljerad beskrivning
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.).
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Sophie BROUILLET, MCU-PH
- Telefonnummer: 33 .4.67.33.59.54
- E-post: s-brouillet@chu-montpellier.fr
Studera Kontakt Backup
- Namn: Fatima BARRY, AHU
- Telefonnummer: 33 4.67.33.64.04
- E-post: fatima.barry@chu-montpellier.fr
Studieorter
-
-
-
Montpellier, Frankrike, 34295
- Rekrytering
- UHMontpellier
-
Kontakt:
- Sophie BROUILLET, MD
- Telefonnummer: 33 4.67.33.59.54
- E-post: s-brouillet@chu-montpellier.fr
-
Kontakt:
- Fatima BARRY, AHU
- Telefonnummer: 33 .4.67.33.64.04
- E-post: fatima.barry@chu-montpellier.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Rate of research in preimplantation embryo development in vitro
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Rate of Identification of new non-invasive biomarkers
Tidsram: 1 day
|
Identification of new non-invasive biomarkers which are predictive for preimplantation embryo development and pregnancy
|
1 day
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Samir HAMAMAH, PUPH, University Hospital, Montpellier
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RECHMPL22_0069
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Placental tissues
-
The Prince Charles HospitalMater Medical Research InstituteAvslutadIdiopatisk lungfibrosAustralien
-
Instituto Materno Infantil Prof. Fernando FigueiraAvslutadHantering av leveransBrasilien
-
Johns Hopkins UniversityRekrytering
-
ConvaTec Inc.AvslutadSårläkning | Venös sårFörenta staterna
-
University of California, San FranciscoRekryteringFostrets tillväxtbegränsning | Svår preeklampsiFörenta staterna
-
The University of Texas Health Science Center,...Skye BiologicsHar inte rekryterat ännu
-
Beijing Hospital of Traditional Chinese MedicineHar inte rekryterat ännuFunktionell förstoppning
-
Instituto Fernandes FigueiraHospital de Clinicas de Porto Alegre; University of Campinas, Brazil; UPECLIN... och andra samarbetspartnersAvslutadFör tidig födsel | PreeklampsiBrasilien
-
University Hospital, AntwerpHar inte rekryterat ännu