Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT03590405
Status:
COMPLETED
Last Update Posted:
2021-12-15
First Post:
2018-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537371', 'term': 'Mullerian aplasia'}, {'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2018-06-17', 'studyFirstSubmitQcDate': '2018-07-06', 'lastUpdatePostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'live birth', 'timeFrame': '3 years', 'description': 'live birth'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['uterus', 'infertility', 'transplantation'], 'conditions': ['Mrk Anomaly', 'Infertility, Female']}, 'descriptionModule': {'briefSummary': 'Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.', 'detailedDescription': 'Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery.\n\nTheory and common animal workshops have been ongoing for 3 years. The team from Bellevue Medical Centre is affiliated to St Joseph, University, Beirut'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria recipient\n\n* age \\< 38 years\n* psychologicaly stable\n* BMI \\< 35\n* no systemic disease\n* no standing medication\n* in a stable relationship or married\n* normal ovarian reserve\n* absolute uterine factor infertility\n* normal kidney function\n\nInclusion criteria donor\n\n* close relative to recipient\n* age \\< 60 years\n* normal pregnancies\n* maximum two cesarean sections\n* BMI \\< 35\n* no major systemic disease\n* no previous major surgery'}, 'identificationModule': {'nctId': 'NCT03590405', 'acronym': 'GOT-BMC-UTx', 'briefTitle': 'Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Uterus Transplantation LD - Feasibility Study - Sahlgrenska - Bellevue Medical Centre', 'orgStudyIdInfo': {'id': 'Sahlgrenska-BMC-UTx'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'uterus transplantation', 'description': 'uterus transplantation from living donor with the donor being close relative', 'interventionNames': ['Procedure: uterus transplantation surgery and IVF']}], 'interventions': [{'name': 'uterus transplantation surgery and IVF', 'type': 'PROCEDURE', 'description': 'IVF before surgery living donor uterus transplantation ET', 'armGroupLabels': ['uterus transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': 'SE-41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Mats Brännström', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Mats Brännström, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Saint Joseph University, at Bellevue Medical Centre', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mats Brännström', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}