An observational study in Infertility, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-02-28.
Sponsored by University Hospital, Montpellier · Observational
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.
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:
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.).
2,540 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's planned enrollment of 5 is below the median of 200 across 722 observational studies indexed under Infertility.
Browse Infertility studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 227 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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
Patients having first trimester voluntary termination of pregnancy in Montpellier university hospital.
Procedure: Placental tissues
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
Rate of research in preimplantation embryo development in vitro
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.
Time frame: 1 day
Rate of Identification of new non-invasive biomarkers
Identification of new non-invasive biomarkers which are predictive for preimplantation embryo development and pregnancy
Time frame: 1 day
Plan to share: Undecided — NC
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Feb 2024, 24 months after the start.
Of 272 non-industry observational studies under Infertility, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 82. This study's planned 24 months is below that.
Counting every sponsor, half of 308 studies reached it within 38 months; a quarter within 16 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier →