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NCT Number: NCT07825649

Modelization of Early Endometrial-trophoblast Molecular Interaction

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.

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Key information

Conditions

Infertility Eclampsia Preeclampsia Female Urogenital Diseases and Pregnancy Complications Genital Diseases Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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). There is no curative treatment, and only delivery of the baby and placenta can cure the patient. During preeclampsia, early placental abnormalities occur in the first trimester of pregnancy, even though the initial stages of human embryo implantation (apposition, adhesion, invasion) and early placentation remain poorly understood.

The primary objective of the MEETMI project is to characterize, in the laboratory, the early endometrium-trophoblast molecular interactions that determine the initial stages of human implantation and placentation.

It is essential to collect human endometrial cells (epithelial and stromal cells) from endometrial biopsies performed as part of routine care in patients who have been previously informed and have given their consent to the research.

For the placental part, following models available in the Lecarpentier's laboratory at the Institut Cochin will be used: human trophoblast stem cells (hTSCs), placental organoids derived from first-trimester placenta .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Determine transcriptionnal and proteic signatures of endometrial-trophoblast

    Time frame: Day 20

    Determine transcriptionnal and proteic signatures of endometrial-trophoblast

Secondary outcomes

  1. Placental Penetration into the extracellular matrix

    Time frame: Day 20

    Quantity of placental penetrating cells will be measured using fluorescent confocal microscopy on live cells and fixed (formol 4%) slices (depth, cells proportion).

    Placental cells will be labelled using specific antibodies (syncytin, hCG).

  2. Viability of the co-culture

    Time frame: Day 20

    LDH assay for Viability of the blastoid/organoid/gastruloidco-culture viability. Viability will be assessed in the cells supernatant dosing Lactate Deshydrogenase (LDH). LDH is a commonly used method for determining cell viability and cell cytotoxicity following cell damage or death, such as by necrosis, apoptosis, and other forms of cell and tissue damage.

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

    Time frame: Day 20

    To vizualise syncytiotrophoblast development, investigators will quantify hCG secretion on the co-culture supernatant.

  4. Development of syncytiotrophoblast: sFLT1 concentration in co-culture supernatant

    Time frame: Day 20

    Investigators will also measure angiogenic factors in the supernantant (sFLT1)

  5. Development of syncytiotrophoblast: PlGF concentration in co-culture supernatant

    Time frame: Day 20

    PlGF concentration will be measured in the co-culture supernatant.

  6. Development of syncytiotrophoblast: Fusion index

    Time frame: Day 20

    Investigators will quantify fusion by calculating fusion index on fixed slices (formol 4%)

Study contacts

Contact information is provided by the study sponsor or research team.

Camille Jung, Pr

CONTACT

[email protected]

01 57 02 31 15

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Collaborators

  • Institut Curie
  • Nantes University Hospital

Registry information

Acronym: MEETMI

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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