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Not yet recruitingNCT07825649MEETMIUpdated Sep 17, 2026

Modelization of Early Endometrial-trophoblast Molecular Interaction

An interventional study of Diagnostic hysteroscopy with endometrial biopsy in Infertility and Eclampsia Preeclampsia, sponsored by Centre Hospitalier Intercommunal Creteil. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Centre Hospitalier Intercommunal Creteil · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the detailed description

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 .

02

Conditions studied

  • Infertility
  • Eclampsia Preeclampsia

Keywords

  • preeclampsia
  • infertility
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 500 is above the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Inclusion criteria

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

Exclusion criteria

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 - or -positive, regardless of viral load
  • Patient whose medical history requires medication that may interfere with trophoblast biology (immunomodulators in cases of diseases, anti-rejection drugs in transplant patients)
  • Known genetic disorder in the patient
  • Unable to understand and sign the consent form
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Hysteroscopy arm

    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

  • ProcedureDiagnostic hysteroscopy with endometrial biopsy

    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.

06

What researchers measure

Primary outcomes

  1. Determine transcriptionnal and proteic signatures of endometrial-trophoblast

    Determine transcriptionnal and proteic signatures of endometrial-trophoblast

    Time frame: Day 20

Secondary outcomes

  1. Placental Penetration into the extracellular matrix

    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).

    Time frame: Day 20

  2. Viability of the co-culture

    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.

    Time frame: Day 20

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

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

    Time frame: Day 20

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

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

    Time frame: Day 20

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

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

    Time frame: Day 20

  6. Development of syncytiotrophoblast: Fusion index

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

    Time frame: Day 20

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07825649
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
May 1, 2036 (estimated)
Completion
May 1, 2036 (estimated)
Last update
Sep 17, 2026

Study contacts

Camille Jung, Pr
Contact
crcpromotion@chicreteil.fr
01 57 02 31 15

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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