[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656453":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":31,"armGroups":39,"interventions":46,"overallOfficials":31,"centralContacts":52,"locations":58,"responsibleParty":76,"collaborators":78,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":31,"studyType":96,"phases":97,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":105,"whyStopped":31,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Centre Hospitalier Intercommunal Creteil","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":31},[9],{"measure":10,"description":10,"timeFrame":11},"Determine transcriptionnal and proteic signatures of endometrial-trophoblast","Day 20",[13,16,19,22,25,28],{"measure":14,"description":15,"timeFrame":11},"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).\n\nPlacental cells will be labelled using specific antibodies (syncytin, hCG).",{"measure":17,"description":18,"timeFrame":11},"Viability of the co-culture","LDH assay for Viability of the blastoid\u002Forganoid\u002Fgastruloidco-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.",{"measure":20,"description":21,"timeFrame":11},"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.",{"measure":23,"description":24,"timeFrame":11},"Development of syncytiotrophoblast: sFLT1 concentration in co-culture supernatant","Investigators will also measure angiogenic factors in the supernantant (sFLT1)",{"measure":26,"description":27,"timeFrame":11},"Development of syncytiotrophoblast: PlGF concentration in co-culture supernatant","PlGF concentration will be measured in the co-culture supernatant.",{"measure":29,"description":30,"timeFrame":11},"Development of syncytiotrophoblast: Fusion index","Investigators will quantify fusion by calculating fusion index on fixed slices (formol 4%)",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE","Despite significant advances in assisted reproductive technology, only 25% of in vitro fertilization (IVF) embryo transfers result in pregnancy, largely due to implantation failure.\n\nPreeclampsia 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.\n\nThe 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.\n\nIt 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.\n\nFor 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 .",[40],{"label":41,"type":42,"description":43,"interventionNames":44},"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.",[45],"Procedure: Diagnostic hysteroscopy with endometrial biopsy",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":31},"PROCEDURE","Diagnostic 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.\n\nThe hysteroscopy will preferably be performed on days 14-16 of the menstrual cycle, outside the menstrual period, in accordance with current practices.\n\nDuring this hysteroscopy:\n\n* Endometrial biopsies will be performed as part of the standard care\n* 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.",[41],[53],{"name":54,"role":55,"phone":56,"phoneExt":31,"email":57},"Camille Jung, Pr","CONTACT","01 57 02 31 15","crcpromotion@chicreteil.fr",[59],{"facility":60,"status":31,"city":61,"state":31,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Chi Creteil","Créteil","94000","France","FR",{"type":66,"coordinates":67},"Point",[68,69],2.46569,48.79266,{"lat":69,"lon":68},[72],{"name":73,"role":55,"phone":74,"phoneExt":31,"email":75},"Edouard Lecarpentier, Pr","0157023235","Edouard.Lecarpentier@chicreteil.fr",{"type":77,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[79,81],{"name":80,"class":6},"Institut Curie",{"name":82,"class":6},"Nantes University Hospital","100656453","modelization-of-early-endometrial-trophoblast-molecular-interaction-100656453",false,"NCT07825649","Modelization of Early Endometrial-trophoblast Molecular Interaction","MEETMI","Inclusion Criteria:\n\n* Medical indication for a diagnostic hysteroscopy between the ages of 18 and 50\n* Comprehensive information provided prior to the hysteroscopy\n* Informed consent signed by the patient\n\nExclusion Criteria:\n\n* Current pregnancy\n* Age \\\u003C 18 or \\> 50\n* Patient refusal\n* Woman under court-ordered protection\n* Not enrolled in the general social security system\n* Patient who is HIV- or HCV-positive, regardless of viral load\n* Patient whose medical history requires medication that may interfere with trophoblast biology (immunomodulators in cases of autoimmune diseases, anti-rejection drugs in transplant patients)\n* Known genetic disorder in the patient\n* Unable to understand and sign the consent form","FEMALE","18 Years","50 Years",{"count":94,"type":95},500,"ESTIMATED","INTERVENTIONAL",[33],"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.",[100,101],"Infertility","Eclampsia Preeclampsia",[103,104],"preeclampsia","infertility","NOT_YET_RECRUITING","2026-09-11",{"date":108,"type":109},"2026-09-17","ACTUAL",{"date":111,"type":95},"2026-10-01",{"date":113,"type":95},"2036-05-01",{"name":5,"class":6},1]