Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-03-02 @ 4:12 AM
Study NCT ID:
NCT02388802
Status:
UNKNOWN
Last Update Posted:
2016-11-08
First Post:
2015-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Clinical Trial of Uterine Transplantation in the United Kingdom
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054315', 'term': 'Oocyte Retrieval'}, {'id': 'D005615', 'term': 'Freezing'}, {'id': 'D007166', 'term': 'Immunosuppressive Agents'}, {'id': 'D005307', 'term': 'Fertilization in Vitro'}, {'id': 'D002585', 'term': 'Cesarean Section'}], 'ancestors': [{'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D020858', 'term': 'Tissue and Organ Harvesting'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D044367', 'term': 'Phase Transition'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D003080', 'term': 'Cold Temperature'}, {'id': 'D013696', 'term': 'Temperature'}, {'id': 'D013816', 'term': 'Thermodynamics'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2015-03-09', 'lastUpdatePostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transplant success', 'timeFrame': '12 months', 'description': 'Efficacy as measured by successful graft transplantation with no clinical, immunological or radiological signs of graft rejection within the first 12 months post-operatively.'}], 'secondaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': '24 months', 'description': 'Efficacy as measured by the number of patients successful of conception by IVF'}, {'measure': 'Live birth rate', 'timeFrame': '36 months', 'description': 'Efficacy as measured by the number of live births following successful conception'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infertility', 'Transplant', 'IVF', 'Hysterectomy', 'Absolute uterine infertility'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '38070921', 'type': 'DERIVED', 'citation': 'Jones BP, Vali S, Kasaven LS, Mantrali I, Saso S, Bracewell-Milnes T, Nicopoullos J, Thum MY, Diaz-Garcia C, Quiroga I, Yazbek J, Smith JR. INvestigational Study Into Transplantation of the Uterus (INSITU): a cross-sectional survey among women with uterine factor infertility in the UK assessing background, motivations and suitability. BMJ Open. 2023 Dec 9;13(12):e073517. doi: 10.1136/bmjopen-2023-073517.'}]}, 'descriptionModule': {'briefSummary': 'Ten patients will undergo uterine transplantation.', 'detailedDescription': 'Ten patients that will be appropriately selected using a variety of physical and psychological assessments. The selected patients will undergo egg retrieval and subsequent freezing of embryos to enable IVF treatment following transplantation. Following uterine transplantation, using deceased donor allografts, the patients will be closely monitored for 12 months clinically, radiologically and immunologically until embryo transfer. Following successful embryo transfer the patients will continue to be monitored antenatally until they are delivered by Caesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Between 18-36 years of age\n* Absolute Uterine factor infertility\n\nExclusion Criteria:\n\n* Poor ovarian reserve - Unsuccessful oocyte retrieval\n* No intercurrent significant medical or psychiatric co-morbidities\n* Previous oncology patients \\<5 years in remission\n* Outside of age range\n* Normal BMI'}, 'identificationModule': {'nctId': 'NCT02388802', 'briefTitle': 'Human Clinical Trial of Uterine Transplantation in the United Kingdom', 'organization': {'class': 'OTHER', 'fullName': 'Womb Transplant UK'}, 'officialTitle': 'The First Human Clinical Trial of Uterine Transplantation in the United Kingdom', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Uterine transplant', 'description': '10 patients will be appropriately selected to undergo oocyte retrieval and freezing. Subsequently deceased donor allograft excision will take place prior to uterine transplantation. Immunosuppressive agents will be used to optimise graft success until successful In-vitro fertilisation and subsequent delivery by Caesarean Section', 'interventionNames': ['Procedure: Oocyte retrieval and freezing', 'Procedure: Deceased Donor Allograft Excision', 'Procedure: Uterine Transplantation', 'Drug: Immunosuppressive Agents', 'Procedure: In-vitro fertilisation', 'Procedure: Caesarean Section']}], 'interventions': [{'name': 'Oocyte retrieval and freezing', 'type': 'PROCEDURE', 'description': '10 Patients will undergo oocyte retrieval and freezing', 'armGroupLabels': ['Uterine transplant']}, {'name': 'Deceased Donor Allograft Excision', 'type': 'PROCEDURE', 'otherNames': ['Cadaveric Donor Allograft Excision'], 'description': 'Appropriately matched uterine transplant allografts will be excised from deceased donors', 'armGroupLabels': ['Uterine transplant']}, {'name': 'Uterine Transplantation', 'type': 'PROCEDURE', 'otherNames': ['Womb Transplant'], 'description': 'Following egg freezing the patients will undergo uterine transplant from deceased donors', 'armGroupLabels': ['Uterine transplant']}, {'name': 'Immunosuppressive Agents', 'type': 'DRUG', 'otherNames': ['Immunosuppressives'], 'description': 'Patients will be appropriately immunosuppressed, whilst being closely monitored clinically, radiologically and immunologically.', 'armGroupLabels': ['Uterine transplant']}, {'name': 'In-vitro fertilisation', 'type': 'PROCEDURE', 'otherNames': ['IVF'], 'description': '12 months after successful transplantation,the patients will undergo IVF', 'armGroupLabels': ['Uterine transplant']}, {'name': 'Caesarean Section', 'type': 'PROCEDURE', 'description': 'Following successful conception and antenatal period, the babies will be born by Caesarean Section', 'armGroupLabels': ['Uterine transplant']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Benjamin P Jones, MBChB BSc', 'role': 'CONTACT', 'email': 'benjamin.jones@nhs.net', 'phone': '+447740358900'}, {'name': 'Srdjan Saso, MRCS PhD BSc', 'role': 'CONTACT', 'email': 'srdjan.saso01@imperial.ac.uk', 'phone': '+447890795182'}], 'overallOfficials': [{'name': 'Richard Smith, FRCOG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial NHS Healthcare Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Womb Transplant UK', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}