[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100338697":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":39,"overallOfficials":25,"centralContacts":25,"locations":45,"responsibleParty":73,"collaborators":25,"id":75,"slug":25,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":25,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":88,"briefSummary":89,"conditions":90,"keywords":25,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Hopital Foch","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Pregnancy","Obtaining of a pregnancy after uterine transplantation from a living donor","3 years",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Safety assessment of the donor, the recipient and the fœtus","Monitoring of all the Adverse events","7 years",{"measure":19,"description":20,"timeFrame":17},"Psychological assessment of the donor and the recipient","Psychological consequences linked to the procedure determined by repeated interviews with psychologists",{"measure":22,"description":23,"timeFrame":24},"Graft Rejection assessment","Donor-specific antobodies monitoring","5 years",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"NA","SINGLE_GROUP","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","The aim of the study is to obtain a pregnancy after uterine transplantation from a living donor. Also, this study will assess (anatomically and functionally) the issue of the transplants of a uterus taken from a living donor and the safety of the living donor (functionally and psychologically)",[34],{"label":35,"type":36,"description":25,"interventionNames":37},"Couple donor - recipient","EXPERIMENTAL",[38],"Procedure: Uterine transplantation",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":25},"PROCEDURE","Uterine transplantation","Uterine transplantation from living donor",[35],[46],{"facility":5,"status":47,"city":48,"state":25,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Suresnes","92150","France","FR",{"type":53,"coordinates":54},"Point",[55,56],2.22929,48.87143,{"lat":56,"lon":55},[59,64,66,69,71],{"name":60,"role":61,"phone":62,"phoneExt":25,"email":63},"Jean-Marc Ayoubi, MD PhD","CONTACT","+33(0)146252339","jm.ayoubi@hopital-foch.org",{"name":60,"role":65,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":67,"role":68,"phone":25,"phoneExt":25,"email":25},"René Frydman, MD PhD","SUB_INVESTIGATOR",{"name":70,"role":68,"phone":25,"phoneExt":25,"email":25},"Marie Carbonnel, MD",{"name":72,"role":68,"phone":25,"phoneExt":25,"email":25},"Aurélie Revaux, MD",{"type":74,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100338697",false,"NCT03689842","Feasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety in Patients With Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)","Inclusion Criteria:\n\nGraft recipient is a patient with Mayer-Rokitansky-Küster-Hauser Type I Uterine Vaginal Agenesis (without renal, cardiac and bone malformations):\n\n* Being aged between 18 and 38 years old\n* In stable couple, with a pregnancy project, favorable psychological evaluation\n* No history of cancer and transfusion\n\nThe living donor is a woman related to the Graft recipient with\n\n* Absence of comorbidity (neurological, nephro-urological pathology, infectious, psychiatric or psychological pathology)\n* Absence of uterine surgery, abdomino-pelvic major pathology history\n\nExclusion Criteria:\n\nGraft recipient:\n\n* Extreme oligo-astheno-spermia and azoospermia in the husband\n* History of abdominopelvic surgery excluding uncomplicated appendectomy; vaginal residue not allowing anastomosis\n\nLiving donor :\n\n* Known thromboembolic risk factor\n* No Compatibility with the recipient (group, rhesus, HLA)",true,"FEMALE","18 Years","65 Years",{"count":85,"type":86},20,"ESTIMATED","INTERVENTIONAL",[27],"In France, one in 4500 women is affected by the MayerRokitantskyKüsterHauser (MRKH) syndrome which is characterized by the absence of uterus at birth. Currently, the only solutions for these patients are:\n\n* Gestational surrogacy, prohibited in France\n* Adoption\n* Resignation\n\nUterine transplantation could become a good alternative.\n\nThis study is conducted in 10 patients with MRKH type I syndrome, who will be transplanted from a living donor uterus",[91],"Mayer Rokitansky Kuster Hauser Syndrome","2025-03-04",{"date":94,"type":95},"2025-03-07","ACTUAL",{"date":97,"type":95},"2017-12-14",{"date":99,"type":86},"2034-12-14",{"name":5,"class":6},1]