Health TrialsbyHealthPanel

Modelization of Early Endometrial-trophoblast Molecular Interaction

ConditionsInfertilityEclampsia Preeclampsia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Current pregnancy

Age < 18 or > 50

Patient refusal

Woman under court-ordered protection

Trial design

Design model

Single group

Treatments tested in this trial

  • Diagnostic hysteroscopy with endometrial biopsy

    Procedure/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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Hysteroscopy armExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Intercommunal Creteil

Lead sponsor

Institut Curie

Collaborator

Nantes University Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: