Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-11 @ 12:37 AM
Study NCT ID:
NCT03252795
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2017-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterus Transplantation From a Multi-organ Donor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'C537371', 'term': 'Mullerian aplasia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2017-06-22', 'studyFirstSubmitQcDate': '2017-08-16', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival of the uterus 1 year after transplantation', 'timeFrame': '1 year after uterus transplantation', 'description': 'Survival of the uterus 1 year after transplantation'}, {'measure': 'Complications after uterus transplantation', 'timeFrame': 'As long as the uterus remains in situ (the uterus will be removed within one year after delivery)', 'description': 'Complications after uterus transplantation'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '4 weeks after embryo transfer', 'description': 'Ongoing pregnancy rate'}, {'measure': 'Take home baby rate', 'timeFrame': '9 months after embryo transfer', 'description': 'Take home baby rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infertility, female', 'Mayer Rokitansky Kuster Hauser Syndrome', 'Transplantation; Deceased donor'], 'conditions': ['Infertility, Female', 'Mayer Rokitansky Kuster Hauser Syndrome']}, 'descriptionModule': {'briefSummary': 'Uterus transplantation: screening, in vitro fertilization \\[IVF\\] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female with Maier-Rokitansky-Kuster-Hauser syndrome\n* Mucosal neovagina of at least 7 cm\n* In a stable relationship for at least 1 year\n* Child wish\n* Good renal function (and presence of both kidneys)\n* Psychologically stable and compliant\n* At least 8 frozen embryos after IVF/intracytoplasmic sperm injection \\[ICSI\\]\n* Living in Belgium and a good health insurance\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Major pelvic surgery\n* Major chronic illnesses\n* Other risk factors or malignancies\n* BMI \\> 30'}, 'identificationModule': {'nctId': 'NCT03252795', 'briefTitle': 'Uterus Transplantation From a Multi-organ Donor', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Uterus Transplantation From a Multi-organ Donor: A Prospective Trial', 'orgStudyIdInfo': {'id': 'EC/2016/0731'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Uterus transplantation', 'interventionNames': ['Procedure: uterus transplantation']}], 'interventions': [{'name': 'uterus transplantation', 'type': 'PROCEDURE', 'description': 'transplantation of a uterus from a deceased donor', 'armGroupLabels': ['Uterus transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'email': 'baarmoedertransplantatie@uzgent.be', 'phone': '+3293322117'}], 'facility': "Ghent University Hospital - Women's Clinic", 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Steven Weyers, MD, PhD', 'role': 'CONTACT', 'email': 'steven.weyers@uzgent.be', 'phone': '+3293325446'}, {'name': 'Sara Somers, MSc', 'role': 'CONTACT', 'email': 'Sara.Somers@uzgent.be', 'phone': '+3293323757'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}