Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT03492632
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2018-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ovarian Reserve in Patients With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples for the measurement of serum FSH,LH,E2,PRL and AMH'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to compare serum AMH levels between the two groups', 'timeFrame': '1 day', 'description': 'Serum AMH levels will be measured (using ELISA) and compared between the two groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psoriasis', 'Anti mullerian hormone', 'ovarian reserve', 'antral follicle count'], 'conditions': ['Psoriasis', 'Anti Mullerian Hormone', 'Ovarian Reserve']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.obgyn.net/asrm-2011/asrm-presentation-higher-risk-premature-ovarian-failure-and-early-menopause-cid', 'label': 'premature ovarian failure in patients with psoriasis'}]}, 'descriptionModule': {'briefSummary': 'Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Autoimmune diseases including psoriasis are linked to premature ovarian reserve. This study aims to measure serum hormones including FSH,LH,E2,PRL and AMH (indicators of ovarian reserve) in women with and without psoriasis.', 'detailedDescription': 'Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Almost 75% of patients are diagnosed before the age of 40. There is also increased evidence on autoimmune disease and their link to premature ovarian failure.Ovarian reserve is important for the reproductive period. The measurements of serum hormones including follicle stimulating hormone (FSH),luteinizing hormone (LH),prolactin (PRL), estradiol (E2) and anti-mullerian hormone (AMH) will give us an idea about the ovarian reserve. The investigators aim is to measure ovarian reserve parameters in patients newly diagnosed with psoriasis and to compare them to healthy controls. Serum FSH,LH,E2,PRL and AMH will be measured on the 3rd day of the cycle.The serum hormone levels will be compared between women with psoriasis and women without psoriasis'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be reproductive age women diagnosed with psoriasis. The control population will be aged and BMI matched women without psoriasis.', 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reproductive age group women: 18-40 years\n* Women diagnosed with psoriasis (case group)\n* Women without psoriasis (control group)\n\nExclusion Criteria:\n\n* Women with PCOS (polycystic ovary syndrome)\n* history of ovarian surgery\n* Body mass index (BMI) over 30\n* Women with other autoimmune diseases including Hashitomo thyroiditis\n* Women with family history of premature ovarian insufficiency (POI)\n* Women with infertility\n* Psoriasis using systemic drugs including steroids and immunosuppressive therapy.'}, 'identificationModule': {'nctId': 'NCT03492632', 'briefTitle': 'Ovarian Reserve in Patients With Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Ovarian Reserve in Patients With Psoriasis', 'orgStudyIdInfo': {'id': '2017/325'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with Psoriasis', 'description': 'Reproductive age women newly diagnosed with psoriasis', 'interventionNames': ['Other: Hormone panel']}, {'label': 'Women without Psoriasis', 'description': 'Reproductive age women without psoriasis to serve as control', 'interventionNames': ['Other: Hormone panel']}], 'interventions': [{'name': 'Hormone panel', 'type': 'OTHER', 'description': 'Blood sampling on the 3rd day of menstrual cycle for the measurement of serum FSH,LH,PRL,E2 and AMH hormone levels.', 'armGroupLabels': ['Women with Psoriasis', 'Women without Psoriasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Suleyman Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Berna Aslan Cetin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kanuni Sultan Suleyman Research and Training Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Berna Aslan Cetin', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}