Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-31 @ 10:38 PM
Study NCT ID:
NCT01114659
Status:
COMPLETED
Last Update Posted:
2014-01-01
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Polycystic Ovary Syndrome(PCOS) With Gene and Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-30', 'studyFirstSubmitDate': '2010-04-29', 'studyFirstSubmitQcDate': '2010-04-30', 'lastUpdatePostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation of PCOS betwwen metabolic and cardiovascular disease.', 'timeFrame': 'Participant were followed for 1 month in study period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous as the syndrome. This first part of study is determine whether genetic polymorphisms influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and controls. Furthermore, women with PCOS were reported with high risk of cardiovascular disease, the investigators planned to calculate the difference of carotid intima-media thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal control to determine the premature atherosclerosis of women with PCOS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Polycystic Ovary Syndrome(PCOS)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women at reproductive age\n* women with PCOS and women without PCOS.\n\nExclusion Criteria:\n\n* young women who had their menarche less than 3 years\n* women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis.'}, 'identificationModule': {'nctId': 'NCT01114659', 'briefTitle': 'The Study of Polycystic Ovary Syndrome(PCOS) With Gene and Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'The Study of Metabolic and Cardiac Vascular Risk in Patients With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'WFH-PCOS-98076'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with PCOS'}, {'label': 'Normal Control'}]}, 'contactsLocationsModule': {'locations': [{'zip': '116', 'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University WanFang Hospital'}], 'overallOfficials': [{'name': 'Ming-I Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wan Fang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Doctor', 'investigatorFullName': 'Ming-I Hsu, MD', 'investigatorAffiliation': 'Taipei Medical University WanFang Hospital'}}}}