[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100265925":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":48,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Women with AUFI","EXPERIMENTAL","Women with AUFI must meet criteria for uterine transplant. In vitro fertilization to obtain 6 (screened) healthy embryos for cryo-preservation precedes uterine transplant from an appropriate donor The recipient will be required to take potent anti rejection medications including Thymoglobulin, Prednisone, Tacrolimus, Mycophenolate Mofetil (MMF) , later substituted with Azathioprine to avoid birth defects. One year later, up to 6 attempts using 1 screened embryo at a time will be tried to achieve pregnancy. During pregnancy, the high risk pregnancy and transplant teams will follow the recipient. The goal is a full term baby and delivery will be by Caesarian section. A second pregnancy may be attempted. Afterward, the uterus will be explanted.",[13],"Procedure: Uterine Transplant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Uterine Transplant","Treating Absolute Uterine Factor Infertility by Uterus Transplant. Potential recipients undergo IVF to obtain 6 embryos for cryopreservation followed by live donor uterine transplant. After 1 year, embryo transfer is done to achieve pregnancy. Delivery is by Caesarian section. The recipient may have up to 2 children by these methods and then the uterus is removed so that immunosuppression can be stopped.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Stefan G Tullius, M.D.","Brigham and Womens Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","617-732-6866","stullius@partners.org",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-71.05977,42.35843,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":20,"phoneExt":20,"email":20},"Stefan Tullius, MD",{"type":25,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Stefan G Tullius","Chief , Division of Transplant Surgery","100265925","phase-2-uterine-transplant-in-absolute-uterine-infertility-auif-100265925",false,"NCT02741102","Uterine Transplant in Absolute Uterine Infertility (AUIF)","Uterine Transplant Inclusion\u002FExclusion Criteria\n\nRECIPIENT:Inclusion Criteria\n\n* Age 18-40\n* Clinical evidence of AUFI (Absolute Uterine Factor Infertility)\n* Able to produce at least 6 normal embryos by IVF for future use\n* Reasonable weight with BMI (Body Mass Index) less than 30.\n* Normal kidney function\n* Able to undergo transplant and be compliant with treatment\n* Has stable partner and social supports\n* Partner willing to undergo psychological evaluation and receive immunizations as recommended\n* Stable home environment to support a child\n\nExclusion Criteria :\n\n* Active smoking, alcohol use or use of illicit drugs\n* Inability to comply with required treatment (taking pills, having biopsies, frequent appointments )\n* Having a condition that would make pregnancy or taking anti rejection medicines too risky.\n* Active infection: Human Immunodeficiency Virus (HIV) , Tuberculosis, Hepatitis B, Hepatitis C\n* History of extensive abdominal or pelvic surgery\n* History of abnormal Papanicolaou test (PAP smear) or genital warts\n* History of pelvic inflammatory disease\n\nDONOR:Inclusion criteria\n\n* Age over 40 up to age 60\n* Has completed having a family\n* Previous pregnancies were carried to term (no miscarriages)\n* Able to take a birth control pill containing estrogen\n* Weight reasonable with BMI (Body Mass Index) of 30 or less\n* Good social supports\n\nExclusion Criteria:\n\n* Active smoking, alcohol use or use of illicit drugs\n* Psychiatric illness\n* Cervical or endometrial polyps (growths) or tumors in the uterus muscle\n* History of more than 1 Caesarean section\n* History of abnormal PAP smear or genital warts\n* Internal scarring from extensive abdominal or pelvic surgery\n* Hypertension, Coronary artery disease, Chronic Obstructive Lung disease (emphysema) and Diabetes\n* Active cancer or incompletely treated cancer\n* Active infection including Human Immunodeficiency Disease (HIV) , Tuberculosis, Hepatitis B or Hepatitis C\n* Significant history of either blood clots or bleeding tendencies\n* Evidence of coercion or exchange of money or goods for donating the organ","FEMALE","18 Years","40 Years",{"count":61,"type":62},10,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE2","PHASE3","This study will examine the feasibility of initiating a uterine transplant program for Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation, Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of follow-up is planned.",[69],"Female Infertility",[71,72],"Infertility","AUFI","2026-04-22",{"date":75,"type":76},"2026-04-28","ACTUAL",{"date":78,"type":62},"2026-05",{"date":80,"type":62},"2028-01",{"name":5,"class":6},1]