Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-25 @ 3:47 AM
Study NCT ID:
NCT02273869
Status:
UNKNOWN
Last Update Posted:
2014-10-24
First Post:
2014-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Ovarian Reserve in Women With Rheumatologic Diseases
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum blood test'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-22', 'studyFirstSubmitDate': '2014-09-29', 'studyFirstSubmitQcDate': '2014-10-22', 'lastUpdatePostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hormone profile', 'timeFrame': '4 years', 'description': 'Assessment of ovarian function using hormone profile and AMH levels in serum, in women with rheumatologic disease.'}, {'measure': 'antral follicular count', 'timeFrame': '4 years', 'description': 'we will use sonography to assess the antral follicular count as a parameter for ovarian reserve in women with rheumatologic disease.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatologic Diseases', 'Ovarian Reserve', 'Infertility']}, 'descriptionModule': {'briefSummary': 'Our infertility unit has started a clinic for women with rheumatological diseases. those women are prone to infertility problems and it might be due to their illness or cytotoxic treatment . In our study we are going to observe the effect of their disease on ovarian reserve. we will assess it by using intravaginal sonography and blood test such as hormonal profile and anti-mullerian hormone (AMH).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women in reproductive age with rheumatoligic disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatologic disease\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02273869', 'briefTitle': 'Assessment of Ovarian Reserve in Women With Rheumatologic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Influence of Rheumatologic Diseases on Fertility and Ovarian Reserve', 'orgStudyIdInfo': {'id': 'MMC-011413-CTIL'}}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'state': 'Israel', 'country': 'Israel', 'facility': 'Sapir Medical Center, Meir Hospital', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Einat Haikin HErzberger, M.D', 'role': 'CONTACT', 'email': 'einatcha1@yahoo.com', 'phone': '972-506728987'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}