Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-30 @ 8:45 PM
Study NCT ID:
NCT01421095
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2011-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovarian Reserve Testing in Female Young Adult Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571801', 'term': 'follitropin alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2011-06-15', 'studyFirstSubmitQcDate': '2011-08-19', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return of menses', 'timeFrame': '3 months', 'description': 'Self reported via bleeding calenders'}], 'secondaryOutcomes': [{'measure': 'Blood levels of FSH', 'timeFrame': '3 months'}, {'measure': 'Blood levels of estradiol', 'timeFrame': '3 months'}, {'measure': 'Blood levels of AMH', 'timeFrame': '3 months'}, {'measure': 'Blood levels of inhibin B', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fertility', 'adolescent', 'young adult', 'cancer survivors'], 'conditions': ['Cancer', 'Infertility']}, 'descriptionModule': {'briefSummary': 'Young adult cancer survivors constitute an under served population to whom fertility potential is particularly important. For female young adult patients, cancer treatment such as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in risks of infertility and premature menopause related to ovarian failure. Reproductive issues are a major concern for young cancer survivors, but one that is understudied. Young cancer survivors have few tools to measure post-treatment ovarian reserve, or the quantity and quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential would not only be an important research tool, but also directly impact clinical management. The purpose of this study is to test if basal and provocative ovarian reserve testing can predict return of menses in female young adult cancer survivors, to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors and healthy controls, and to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors on and off of combined estrogen and progesterone hormone products.\n\nParticipants will be asked to keep track of their periods over three months. If a participant is taking birth control pills, patches, or vaginal ring, they will asked to come off the birth control for 3 months. Participants will also be asked to undergo ovarian reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.', 'detailedDescription': 'Same as brief summary'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenarchal\n* Cancer diagnosis\n* Prior exposure to gonadotoxic therapy, inclusive of chemothearpy, pelvic or total body irradiation, unilateral oophorectomy\n* A minimum of 1 year since completion of gonoadotoxic therapy\n* Intact uterus\n* At least one ovary\n\nExclusion Criteria:\n\n* Estrogen receptor positive cancers'}, 'identificationModule': {'nctId': 'NCT01421095', 'briefTitle': 'Ovarian Reserve Testing in Female Young Adult Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Ovarian Reserve Testing in Female Young Adult Cancer Survivors', 'orgStudyIdInfo': {'id': 'ORT study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Basal Testing', 'interventionNames': ['Drug: recombinant FSH']}], 'interventions': [{'name': 'recombinant FSH', 'type': 'DRUG', 'otherNames': ['Gonal F'], 'description': 'Each participant will recieve recombinant FSH (150 IU) intravenously', 'armGroupLabels': ['Basal Testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91351', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Moores Cancer Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'H. Irene Su, MD MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Reproductive Medicine', 'investigatorFullName': 'Hui-Chun Irene Su', 'investigatorAffiliation': 'University of California, San Diego'}}}}