InfertilityMEETMINCT07825649
Modelization of Early Endometrial-trophoblast Molecular Interaction
A study testing Diagnostic hysteroscopy with endometrial biopsy in people with Infertility and Eclampsia Preeclampsia, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility, Eclampsia Preeclampsia
- What is being tested?
- Diagnostic hysteroscopy with endometrial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 1 May 2036
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chi Creteil
Créteil, 94000
Edouard Lecarpentier, Pr, 0157023235, Edouard.Lecarpentier@chicreteil.fr
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). 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 .
- Conditions
- Infertility, Eclampsia Preeclampsia
- Being tested
- Diagnostic hysteroscopy with endometrial biopsy
- Keywords
- preeclampsia, infertility
- Medical subject headings
- Infertility, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic hysteroscopy with endometrial biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Diagnostic hysteroscopy with endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine transcriptionnal and proteic signatures of endometrial-trophoblast
Determine transcriptionnal and proteic signatures of endometrial-trophoblast
Measured: Day 20
Secondary outcomes (6)
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).
Measured: Day 20
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.
Measured: Day 20
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.
Measured: Day 20
Development of syncytiotrophoblast: sFLT1 concentration in co-culture supernatant
Investigators will also measure angiogenic factors in the supernantant (sFLT1)
Measured: Day 20
Development of syncytiotrophoblast: PlGF concentration in co-culture supernatant
PlGF concentration will be measured in the co-culture supernatant.
Measured: Day 20
Development of syncytiotrophoblast: Fusion index
Investigators will quantify fusion by calculating fusion index on fixed slices (formol 4%)
Measured: Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2036 (estimated)
- Study completion1 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Curie, Nantes University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825649
- Sponsor's protocol ID
- MEETMI
- Acronym
- MEETMI
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No