Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-03-09 @ 1:58 AM
Study NCT ID:
NCT02659592
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2016-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-19', 'studyFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2016-01-19', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'FSH levels (miU/ml)', 'timeFrame': 'up to one year', 'description': 'as part of the endocrine profile'}, {'measure': 'E2 (pmol/ml),', 'timeFrame': 'up to one year', 'description': 'as part of the endocrine profile'}, {'measure': 'number of embryos per IVF cycle', 'timeFrame': 'through study completion (up to 11 years following transplantation)'}, {'measure': 'IVF cycles pregnancy rates (%)', 'timeFrame': 'through study completion (up to 11 years following transplantation)', 'description': 'number of pregnancies obtained via IVF devided by number of IVF cycles'}], 'primaryOutcomes': [{'measure': 'menstrual bleeding (yes/no)', 'timeFrame': 'up to one year', 'description': 'recurrence of menstrual bleeding- yes or no'}, {'measure': 'number of oocytes per IVF cycle', 'timeFrame': 'through study completion (up to 11 years following transplantation)', 'description': 'number of aspirated oovytes per one IVF cycle performed'}, {'measure': 'pregnancies', 'timeFrame': 'through study completion (up to 11 years following transplantation)', 'description': 'spontaneous or post IVF pregnancy rates (%)'}, {'measure': 'live births', 'timeFrame': 'through study completion (up to 11 years following transplantation)', 'description': 'live birth rates (%)'}], 'secondaryOutcomes': [{'measure': 'disease reccurence', 'timeFrame': 'through study completion (7 months to 141 months following transplantation)', 'description': 'incidence of cancer disease recurrence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fertility preservation', 'ovarian tissue transplantation', 'ovarian endocrine function', 'assisted reproductive technology', 'pregnancy and live birth'], 'conditions': ['Reproductive Performance Following Ovarian Transplantation']}, 'referencesModule': {'references': [{'pmid': '27181924', 'type': 'DERIVED', 'citation': "Meirow D, Ra'anani H, Shapira M, Brenghausen M, Derech Chaim S, Aviel-Ronen S, Amariglio N, Schiff E, Orvieto R, Dor J. Transplantations of frozen-thawed ovarian tissue demonstrate high reproductive performance and the need to revise restrictive criteria. Fertil Steril. 2016 Aug;106(2):467-74. doi: 10.1016/j.fertnstert.2016.04.031. Epub 2016 May 12."}]}, 'descriptionModule': {'briefSummary': 'Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology centers. Patients: 20 cancer survivors who underwent ovarian transplantation of frozen-thawed ovarian tissue, with the aim to conceive.\n\nInterventions: Ovarian tissue cryopreservation (OTCP) and transplantation, endocrine monitoring, IVF.', 'detailedDescription': 'Main Outcomes expected:\n\nEndocrine profile IVF results, pregnancy rates following transplantation of ovarian tissue live-births rates following transplantation of ovarian tissue cancer disease recurrence'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: infertile patients who stored ovarian tissue to preserve fertility prior to potentially sterilizing cancer treatments\n\n\\-\n\nExclusion Criteria:\n\n* active disease, fertile patients post cancer treatment'}, 'identificationModule': {'nctId': 'NCT02659592', 'briefTitle': 'Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Transplantation of Frozen Thawed Ovarian Tissue Demonstrates High Reproductive Performance and the Need to Revise Restrictive Criteria', 'orgStudyIdInfo': {'id': 'SHEBA-03-3026-DM-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'infertile cancer survivors', 'description': 'infertile cancer survivors who seek to conceive and had frozen ovarian tissue when diagnosed years before', 'interventionNames': ['Procedure: transplantation of ovarian tissue']}], 'interventions': [{'name': 'transplantation of ovarian tissue', 'type': 'PROCEDURE', 'description': 'operation(mini laparotomy) for transplantation of frozen- thawed ovarian tissue', 'armGroupLabels': ['infertile cancer survivors']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Prof. Dror Meirow', 'investigatorAffiliation': 'Sheba Medical Center'}}}}