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

NCT05231551 | Unknown

• 1 other identifier: RECHMPL22_0069
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Keywords

Embryo development; Implantation; Oxygen; Trophoblast organoid; In vitro fertilization

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (1)

• Rate of Identification of new non-invasive biomarkers

  1 day

Study Arms (1)

Single-group study

Patients having first trimester voluntary termination of pregnancy in Montpellier university hospital.

Procedure: Placental tissues

Interventions

Placental tissues PROCEDURE

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

Single-group study

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \- No smoking patients without drug consumption or previous medication who are having first trimester voluntary termination of pregnancy surgically or medically induced.

You may not qualify if:

• \- Patients smoking, drug consumption, previous medication

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissues of first-trimester human placentas after abortion donated to research

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Samir HAMAMAH, PUPH

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Sophie BROUILLET, MCU-PH

CONTACT

.4.67.33.59.54; s-brouillet@chu-montpellier.fr

Fatima BARRY, AHU

CONTACT

4.67.33.64.04; fatima.barry@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 9, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 28, 2024
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

FR (1)