Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-04 @ 8:59 AM
Study NCT ID:
NCT04082169
Status:
UNKNOWN
Last Update Posted:
2019-09-09
First Post:
2019-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Causes and Consequences of Primary Ovarian Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}, {'id': 'D008594', 'term': 'Menopause, Premature'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autoimmune', 'timeFrame': 'one day', 'description': 'Prevalence of primary ovarian insufficiency (POI) with autoimmune etiology based on positive autoantibodies toward steroidogenic cells'}, {'measure': 'Genetic', 'timeFrame': 'one day', 'description': 'Prevalence of POI with genetic etiology defined by detection of genetic defects in a NGS panel'}, {'measure': 'Endocrine disrupting chemicals', 'timeFrame': 'one day', 'description': 'Characterize the cohort of women with POI, including testing for environmental factors'}], 'secondaryOutcomes': [{'measure': 'Phenotype description', 'timeFrame': 'one day', 'description': 'Describe phenotypical characteristics including menstrual characteristics, hormone profile, BMD'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Ovarian Insufficiency', 'Premature Menopause']}, 'referencesModule': {'references': [{'pmid': '37953503', 'type': 'DERIVED', 'citation': 'Vogt EC, Bratland E, Berland S, Berentsen R, Lund A, Bjornsdottir S, Husebye E, Oksnes M. Improving diagnostic precision in primary ovarian insufficiency using comprehensive genetic and autoantibody testing. Hum Reprod. 2024 Jan 5;39(1):177-189. doi: 10.1093/humrep/dead233.'}]}, 'descriptionModule': {'briefSummary': '100 women with primary ovarian insufficiency will be included for extensive diagnostic workup to improve diagnostic precision by extended autoantibody screening and genetic and toxicological testing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 women with primary ovarian insufficiency defined as absence of menstruation more than 4 months and serum level of follicle stimulation hormone (FSH) in menopausal range at 2 or more occations', 'genderDescription': 'Ovarian insufficiency', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Women 40 years or younger, more than 4 months amenorrhea, more than 2 FSH measurements in menopausal range (drawn at least 2 months apart), ability to provide informed concent -\n\nExclusion Criteria:History of oophorectomy, chemotherapy or radiation\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04082169', 'acronym': 'Clinical POI', 'briefTitle': 'Causes and Consequences of Primary Ovarian Insufficiency', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Causes and Consequences of Primary Ovarian Insufficiency', 'orgStudyIdInfo': {'id': '2018/1206'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Elinor Vogt, MD', 'role': 'CONTACT', 'email': 'elinor.vogt@uib.no', 'phone': '+4793899380'}, {'name': 'Marianne Oksnes, PHD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'HaukelandUH', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'centralContacts': [{'name': 'Eystein Husebye, prof', 'role': 'CONTACT', 'email': 'eyhu@helse-bergen.no', 'phone': '+4755975000'}], 'overallOfficials': [{'name': 'Kahtan Al-Azawy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Haukeland University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}