Modelization of Early Endometrial-trophoblast Molecular Interaction

NCT07825649 | Not Yet Recruiting

• 1 other identifier: MEETMI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Despite significant advances in assisted reproductive technology, only 25% of in vitro fertilization (IVF) embryo transfers result in pregnancy, largely due to implantation failure. Preeclampsia complicates 2 to 5% of pregnancies, causes 76,000 maternal deaths worldwide each year, and is one of the leading causes of extreme prematurity (20% of premature births occurring before 32 weeks of gestation). The MEETMI project aims to characterize, in the laboratory, the early endometrium-trophoblast molecular interactions that determine the initial stages of human implantation and placentation. As part of routine care, patients will undergo a diagnostic hysteroscopy during which a endometrial biopsy may be performed. If the patient consents to participate in the study, an additional extended endometrial biopsy will be collected for research purposes.

Conditions

Infertility; Eclampsia Preeclampsia

Keywords

preeclampsia; infertility

Outcome Measures

Primary Outcomes (1)

• Determine transcriptionnal and proteic signatures of endometrial-trophoblast

  Determine transcriptionnal and proteic signatures of endometrial-trophoblast

  Day 20

Secondary Outcomes (6)

• Placental Penetration into the extracellular matrix

  Day 20

• Viability of the co-culture

  Day 20

• Development of syncytiotrophoblast: To vizualise syncytiotrophoblast development: hCG concentration in co-culture supernatant

  Day 20

• Development of syncytiotrophoblast: sFLT1 concentration in co-culture supernatant

  Day 20

• Development of syncytiotrophoblast: PlGF concentration in co-culture supernatant

  Day 20

Study Arms (1)

Hysteroscopy arm

EXPERIMENTAL

Patients will undergo a diagnostic hysteroscopy during which a endometrial biopsy may be performed. An additional extended endometrial biopsy will be collected for research purposes.

Procedure: Diagnostic hysteroscopy with endometrial biopsy

Interventions

Diagnostic hysteroscopy with endometrial biopsy PROCEDURE

During the gynecological consultation prior to the diagnostic hysteroscopy, patients who meet the inclusion criteria will be offered participation in the MEETMI study. The patient's consent will be obtained during this consultation or no later than the day of the hysteroscopy. The hysteroscopy will preferably be performed on days 14-16 of the menstrual cycle, outside the menstrual period, in accordance with current practices. During this hysteroscopy: * Endometrial biopsies will be performed as part of the standard care * An expanded endometrial biopsy will be performed for research purposes. The extended biopsy is taken from the same location, with the same dimensions, and using the same technique as the biopsies performed as part of standard care. The extended biopsy does not significantly increase either the duration of the procedure or the risk associated with diagnostic hysteroscopy.

Hysteroscopy arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Medical indication for a diagnostic hysteroscopy between the ages of 18 and 50
• Comprehensive information provided prior to the hysteroscopy
• Informed consent signed by the patient

You may not qualify if:

• Current pregnancy
• Age \< 18 or \> 50
• Patient refusal
• Woman under court-ordered protection
• Not enrolled in the general social security system
• Patient who is HIV- or HCV-positive, regardless of viral load
• Patient whose medical history requires medication that may interfere with trophoblast biology (immunomodulators in cases of autoimmune diseases, anti-rejection drugs in transplant patients)
• Known genetic disorder in the patient
• Unable to understand and sign the consent form

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Institut Curie: collaborator
• Nantes University Hospital: collaborator

Study Sites (1)

Chi Creteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Infertility; Pre-Eclampsia

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Camille Jung, Pr

CONTACT

01 57 02 31 15; crcpromotion@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2036
• Study Completion (Estimated): May 1, 2036
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)