Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-02 @ 3:03 AM
Study NCT ID:
NCT01993732
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2013-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015925', 'term': 'Cryopreservation'}], 'ancestors': [{'id': 'D014021', 'term': 'Tissue Preservation'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D011309', 'term': 'Preservation, Biological'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2013-09-18', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return of hormones produced by the ovarian tissue', 'timeFrame': '3 months after re-implantation'}], 'secondaryOutcomes': [{'measure': 'Development of egg(s) appropriate for use in in vitro fertilization', 'timeFrame': 'Participants will be followed through their reproductive years (until the patient reaches 45 years of age)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Cryopreservation', 'Ovarian Function', 'In Vitro'], 'conditions': ['Cancer', 'Effects of Chemotherapy', 'Unspecified Complication of Bone Marrow Transplant', 'Auto Immune Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to retrieve and cryopreserve ovarian tissue from females undergoing a treatment that may lead to irreversible loss of ovarian function.', 'detailedDescription': 'The aim of this preliminary study is to retrieve and properly cryopreserve ovarian tissue for autotransplantation in any premenopausal female whose ovarian function is threatened in a physiological, pathological or iatrogenic manner in an effort to observe the return of ovarian endocrine function and development of egg(s) appropriate for use in in vitro fertilization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be female.\n* Patient must have a disease process where the disease or its treatment adversely affects ovarian function.\n* Patient must be recommended for this study by their oncologist or specialist.\n* Patient (or legally authorized representative) must sign an informed consent.\n\nExclusion Criteria:\n\n* Patients cannot be male.\n* Patients must not be HIV positive.\n* Patient cannot have a poor diagnosis such that she is not expected to survive to adulthood.\n* Patient cannot have any medical condition that would contraindicate surgery.\n* Patient cannot have any medical condition that would contraindicate general anesthesia.\n* Patient cannot have any medical condition that would contraindicate pregnancy.'}, 'identificationModule': {'nctId': 'NCT01993732', 'briefTitle': 'Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Ovarian Tissue Cryopreservation As A Means Of Preserving Ovarian Function in Females Undergoing Therapeutic Procedures That Will Potentially Lead To The Irreversible Loss of Ovarian Function', 'orgStudyIdInfo': {'id': '126204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retrieval and Cryopreservation', 'description': 'Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed.', 'interventionNames': ['Procedure: Retrieval and Cryopreservation']}], 'interventions': [{'name': 'Retrieval and Cryopreservation', 'type': 'PROCEDURE', 'description': 'Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed.', 'armGroupLabels': ['Retrieval and Cryopreservation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert and The Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Estil Strawn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director of Division of Reproductive Endocrinology and Infertility', 'investigatorFullName': 'Estil Strawn', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}