[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uterine-factor-infertility\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uterine-factor-infertility":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":28,"conditions":29,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100488967","phase-2-uterus-transplantation-to-treat-infertility-100488967",false,"NCT05646992","Uterus Transplantation to Treat Infertility","OPRTUNTI: Offering Potential for Reproduction Through Transplantation of Uterus iN the Treatment of Infertility","OPRTUNTI","INCLUSION CRITERIA -\n\nRecipient Inclusion Criteria:\n\n* Genotypic female of any race, color, or ethnicity.\n* Uterine factor infertility.\n* Aged 18-38 years at time of egg retrieval.\n* Strong desire to undergo uterus transplant in order to become pregnant and give birth to a child.\n* Embryo cryopreservation with embryos located at Johns Hopkins:\n\n  * Has a minimum of 4-8 cryopreserved normal embryos following Preimplantation Genetic Screening (PGS-screening).\n\nOR o Is willing to undergo egg retrieval, in vitro fertilization, and PGS-screening to cryopreserve a minimum of 4-8 normal embryos.\n\n* Willingness to undergo embryo implantation after uterus transplantation to achieve pregnancy.\n* In the opinion of the study team, makes a reasonable effort to identify and refer her own potential uterus donor to the study team.\n* Completes the protocol informed consent form.\n* Non-smoker, defined by having never smoked or having quit \\>6 consecutive months prior to screening.\n* No co-existing medical condition which, in the opinion of the study team, could affect the immunosuppression protocol, surgical procedure, or ability to be pregnant or bear a child. (See Donor and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of uterus transplantation.)\n* Negative serum pregnancy test.\n* Blood type compatible with donor.\n* Negative crossmatch with donor.\n* Patient agrees to comply with the protocol and states a dedication to the treatment regime.\n* Agrees to uterus explanation following birth of a child and or 5 years without successful pregnancy.\n\nDonor Inclusion Criteria:\n\n* Genotypic female with an intact uterus.\n* Medical history includes known successful pregnancy (e.g., gravid uterus).\n* Aged 25 - 65 years.\n* Consents to uterus donation and required pre-donation screening.\n* For females of child-bearing potential: Negative serum pregnancy test.\n* Blood type compatible with recipient.\n* Negative crossmatch with recipient.\n\nDonor and Recipient Inclusion Criteria:\n\n* USA citizen or equivalent.\n* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).\n* BMI ≤35\n\n  o A higher BMI may be accepted at the discretion of the study team.\n* Negative for HIV at transplant.\n* Negative for malignancy for past 5 years.\n\nEXCLUSION CRITERIA-\n\nDonor and Recipient Exclusion Criteria:\n\n* Positive for any of the following conditions:\n\n  * Insulin-dependent diabetes mellitus.\n  * Untreated sepsis.\n  * HIV (active or seropositive).\n  * Active tuberculosis.\n  * Active Hepatitis B infection.\n  * Active Hepatitis C infection.\n  * Viral encephalitis.\n  * Toxoplasmosis.\n  * Current\u002Frecent (within 3 months of donation\u002Fscreening consent) IV drug abuse.\n  * Significant cardiac disease\n  * Significant vascular disease o\n* Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte Antigens (HLA) antibodies.\n* Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.\n* Mixed connective tissue diseases and collagen diseases that can result in poor wound healing after surgery.\n* Severe neurologic deficits.\n* Patients considered unsuitable per the consulted Psychiatric\u002FPsychologic appraisal.\n* A history of medical non-compliance.\n\nDonor Only Exclusion Criteria:\n\n* Previous injury to the uterus including giving birth by Cesarean section.\n* History of radiation therapy to the abdominal area.\n* Other medical conditions, as determined by the study physicians, that would preclude donation.\n\nRecipient Only Exclusion Criteria:\n\n• Conditions that, in the opinion of the study team, may expose the recipient to unacceptable risks under immunosuppressive treatment.",true,"FEMALE","18 Years","38 Years",{"count":22,"type":23},40,"ESTIMATED","INTERVENTIONAL",[26,27],"PHASE2","PHASE3","This research study will use uterus transplantation to treat uterine factor infertility, also known as the inability to bear children due to not having a uterus. The purpose of this study is to enable women seeking genetically-related children and the childbearing experience to experience pregnancy and birth a child. In this study, living donors will undergo surgery to give the donor's uterus to another woman. The woman who receives the transplant will take immunosuppression to keep the uterus and herself healthy. Because taking immunosuppressive medicine has side effects, uterus transplantation is intended to be temporary, lasting about 5 years.\n\nThe goals of the study are successful pregnancy and the birth of one, and possibly two, healthy babies per transplant patient. The uterus is to be removed and immunosuppression stopped following the birth of a child. Offspring are delivered by Caesarian section, at which time the transplant may also be removed.\n\nTransplant candidates must have fertilized, frozen (cryopreserved) embryos at a Johns Hopkins facility before undergoing transplantation. Transplant candidates will be asked to identify candidates' potential uterus donor. Altruistic donors, or women who want to donate without knowing a potential recipient, may also participate. All potential donors will be screened to see if the donors are a good match for a recipient and are healthy enough to have the donation surgery.\n\nStudy Duration:\n\n* Uterus Donors: Screening through about 12 months following the transplant operation.\n* Uterus Recipients: Recipients may have the uterus for about 5 years. After the transplant is removed, the study team will ask for yearly follow-ups for another 5 years.\n* Children born from transplanted uteruses: The study team asks to follow offspring yearly through age 21 years.",[30],"Uterine Factor Infertility",[32,33,34,35,36,37,38,39,40],"Uterus\u002FTransplantation","Uterus\u002FSurgery","Vascularized Composite Allotransplantation (VCA)","Immunosuppression","Mayer-Rokitansky-Küster-Hauser (MRKH)","Allotransplantation","Humans","Female","Hysterectomy","RECRUITING","2026-08-10",{"date":44,"type":45},"2026-08-11","ACTUAL",{"date":47,"type":45},"2023-03-01",{"date":49,"type":23},"2043-02-28",{"name":51,"class":52},"Johns Hopkins University","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":24,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":53},"100495063","transplantation-of-uterus-for-uterine-infertility-from-living-donor-or-deceased-donor-100495063","NCT05726305","Transplantation of Uterus for Uterine infertiLIty From Living Donor or Deceased Donor","TULIPE","Inclusion Criteria for UT recipient:\n\n* Patient aged 18 to 40 at the time of the UT;\n* BMI (Body Mass Index) ≤ 30 kg\u002Fm²;\n* With AUFI (type 1 or 2 MRKH syndrome and hysterectomy);\n* Informed about the possibility of adoption;\n* Compatibility with the donor (ABO group, Human Leukocyte Antigen (HLA) typing);\n* Up-to-date vaccinations;\n* Able to reach the transplant center in less than 11 hours (applicable only for the \"deceased donor\" arm);\n* Having a parental project that is formulated by a heterosexual couple, by a couple of women or by a single woman;\n* Vaginal cup of length greater than or equal to 7 cm.\n\nInclusion Criteria for a deceased brain-dead uterus donor:\n\n* Any person who is brain dead and who has been duly diagnosed with the following criteria: Female gender;Age ≤ 42 years;Compatibility with the recipient (ABO group, HLA typing).\n\nInclusion Criteria for a live uterus donor:\n\n* Patient belonging to the family of the recipient (mother, sister, aunt, mother-in-law...) or any person who can prove a stable emotional relationship for more than 2 years with the recipient (paragraphs 1 and 2 of Article L.1231-1 of the Public Health Code);\n* Age ≥ 37 years and ≤ 62 years ;\n* BMI ≤ 30 kg\u002Fm²;\n* Having completed all her parenthood plans and no longer having any plans of pregnancy;\n* Having had at least one live-born child at term (i.e. after 37 weeks of of amenorrhea);\n* Compatibility with the recipient (ABO group, HLA typing);\n* Normal suprapubic and\u002For endovaginal ultrasound or pelvic Magnetic Resonance Imaging (MRI), including uterine (no uterine abnormalities);\n* Satisfactory uterine vessels assessed by MRI angio.\n\nExclusion Criteria for UT recipient:\n\n* Patient with acquired uterine infertility and having had one or more children;\n* Non-stable psychological state defined by a clinical psychologist after a qualitative interview;\n* Severe co-morbidity;\n* Association of severe abnormality with MRKH syndrome other than renal such as a cardiac malformation;\n* A single pelvic kidney (urinary malformation that can be associated with MRKH syndrome);\n* Pathogenic parental genetic anomaly which may lead to medical termination of pregnancy in the current state of knowledge;\n* Diabetes (HbA1c \\> 6%);\n* Disorders of hemostasis: Prothrombin rate \\\u003C70%;\n* Hemoglobin abnormality;\n* Existence of hypertension;\n* Vaginal reconstruction (neovagina) by digestive segment (colonic plastic surgery or other);\n* History of major abdominal or pelvic surgery;\n* Known thrombophilia (acquired or constitutional);\n* HIV (Human Immunodeficiency Virus), HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), HAV (Hepatitis A Virus), HTLV (Human T-Lymphotropic Virus) serology positive and presence of irreversible communicable infectious diseases;\n* Positive vaginal hPV-HR (human Papilloma Virus High Risk) test;\n* Signs of chronic renal disease;\n* Drug addiction or alcoholism not weaned for more than 2 years or drug addiction or excessive alcohol consumption (\\> 30 g\u002Fday of alcohol) current;\n* History of cancer less than 10 years old, cancer under treatment (except in the cancer in situ, or basal cell skin lesion) or diagnosed during the selection process;\n* History of pelvic radiotherapy or vaginal brachytherapy regardless of when this irradiation was performed;\n* Known psychiatric pathology;\n* Active tuberculosis (i.e. under treatment);\n* Known or suspected contraindications to one or more of the treatments (active substance or excipient(s)) to be administered for the purposes of the study and\u002For essential treatment having an interaction\u002Fimpact with one of the treatments planned by the research;\n* Existence of organ dysfunction not compatible with the uterine transplantation protocol;\n* History of smoking (defined as consumption greater than 20 packs\u002Fyear) not weaned for more than 2 years or active smoker.\n\nExclusion Criteria for a deceased brain-dead uterus donor:\n\n* Initial circulatory arrest of more than 10 minutes;\n* Opposition to organ donation (register of refusals) or to uterine removal by a relative of the deceased;\n* Chronic and uncontrolled hypertension;\n* Absence of uterus (history of hysterectomy or uterine agenesis);\n* Presence of uterine pathology;\n* Delivery less than 6 months ago or ongoing pregnancy;\n* History of several caesarean sections (multi-scarred uterus: more than 2);\n* History of major abdominal or pelvic surgery;\n* Infection of the sepsis type or uncontrolled infection (bacterial, viral viral, parasitic fungal, active Chagas disease);\n* Encephalitis of viral origin or febrile of uncertain origin or meningoencephalitis of unknown origin;\n* Risk of Prion disease transmission;\n* Presence of an infectious disease: HIV, HCV, HBV, HTLV and presence of irreversible communicable infectious diseases;\n* Carrying of human Papilloma Virus High Risk (hPV-HR) class 1 positive in the genital tract if known before transplantation;\n* Positive EBV (Epstein-Barr Virus) serology in the donor if the recipient is EBV negative for EBV ;\n* Positive pre-transplant virtual crossmatch;\n* Donor\u002Frecipient ABO final check in the operating room before transplantation positive;\n* Drug addiction or alcoholism not weaned for more than 2 years or drug addiction or excessive alcohol consumption (\\> 30 g\u002Fday of alcohol) current;\n* History of cancer less than 5 years old, cancer under treatment (except in the cancer in situ, or basal cell skin lesion) ;\n* Active tuberculosis (i.e. under treatment);\n* History of smoking (defined as consumption greater than 20 packs\u002Fyear) not weaned for more than 2 years or active smoker.\n\nExclusion Criteria for a live uterus donor:\n\n* Non-stable psychological state defined by a clinical psychologist clinician after a qualitative interview;\n* Severe co-morbidity;\n* Diabetes (HbA1c \\> 6%);\n* Hemostasis disorders: Prothrombin rate \\\u003C70%;\n* Hemoglobin abnormality;\n* hypertension treated with more than 2 antihypertensive drugs;\n* Delivery less than 6 months ago or ongoing pregnancy;\n* History of cervical pathology;\n* History of recurrent miscarriage syndrome (defined as 3 consecutive consecutive miscarriages);\n* History of premature delivery before 36 weeks of amenorrhea;\n* History of pre-eclampsia;\n* History of caesarean sections;\n* History of major uterine surgery;\n* History of major abdominal or pelvic surgery;\n* Endometrial biopsy and diagnostic hysteroscopy showing an abnormality of the endometrium;\n* Known thrombophilia (acquired or constitutional);\n* HIV, HCV, HBV, HTLV serology positive and presence of irreversible communicable infectious diseases;\n* Positive vaginal hPV-HR (human Papilloma Virus High Risk) test;\n* PCR (Polymerase Chain reaction) on HSV (Herpes Simplex Virus) 1\u002F2 positive sample;\n* Abnormal vaginal swab;\n* Signs of chronic kidney disease;\n* Risks of Prion disease transmission;\n* Drug addiction or alcoholism not weaned for more than 2 years or drug addiction or excessive alcohol consumption (\\> 30 g\u002Fday of alcohol) current;\n* History of cancer less than 10 years old, cancer under treatment (except in the cancer in situ, or basal cell skin lesion) or diagnosed during the selection process;\n* History of pelvic radiotherapy or vaginal brachytherapy regardless of when this irradiation was performed;\n* Known psychiatric pathology;\n* Active tuberculosis (i.e. under treatment);\n* Presence of a known thromboembolic risk factor;\n* Angio-MRI, CT angiography and\u002For arteriography revealing an anomaly incompatible with uterine transplantation;\n* History of smoking (defined as consumption greater than 20 packs\u002Fyear) not weaned for more than 2 years or active smoker.",{"count":62,"type":23},16,[64],"NA","Patients with absolute Uterine Factor Infertility (AUFI) are infertile due to the absence of a uterus. The absence of a uterus can be either iatrogenic (hysterectomy for gynecological pathology such as cancer or for obstetric pathology such as postpartum hemorrhage with hysterectomy for hemostasis), or congenital with utero-vaginal agenesis including Mayer Rokitansky Küster Hauser syndrome (MRKH) is the most common syndrome of uterine agenesis.\n\nAlongside the AUFI, there is Non-Absolute Uterine Factor Infertility (NAUFI) which corresponds to patients with a uterus in place but which is altered by different pathologies, most often acquired, making it unsuitable for embryonic implantation and preventing the patient to get pregnant.\n\nUterus Transplantation (UT) represents an interesting alternative to the treatment of AUFI and potentially NAUFI (in the event of a uterus present but unsuitable for implantation) to access parenthood, especially since it is the only proposal that allows the patient to be both the surrogate mother, the biological mother (in case of simple donation) and the legal mother.\n\nMany animal experiments have been accelerated since the beginning of the 21st century demonstrating that uterus transplantation was technically feasible and that pregnancy was possible.\n\nIn humans, several teams have recently performed several uterus transplants and have shown that this procedure is possible whether the donor is alive or dead (state of brain death).\n\nIn France, two teams (Foch and Limoges) have developed a uterus transplantation program. One in the context of living donors and the other of a deceased donors.\n\nAt the University Hospital of Rennes, we want to offer a UT program allowing access to a living or deceased donor for women with AUFI (type 1 or 2 MRKH syndrome and hysterectomy).",[30],"2025-07-28",{"date":69,"type":45},"2025-07-29",{"date":71,"type":45},"2024-01-23",{"date":73,"type":23},"2037-12",{"name":75,"class":52},"Rennes University Hospital"]