Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT01856894
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2013-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Anti-Mullerian Hormone (AMH) Levels in Overweight and Obese Adolescent Girls With Polycystic Ovaries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-16', 'studyFirstSubmitDate': '2013-05-14', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovarian reserve, as measured by basal follicle stimulating hormone/anti-Mullerian hormone/antral follicle count', 'timeFrame': 'Three months'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'Three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['polycystic ovary syndrome', 'Anti-Mullerian Hormone', 'obesity'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'In this study the investigators aimed to investigate whether there is a relation between body weight and serum anti mullerian hormone levels in adults with polycystic ovary syndrome. For this purpose the investigators designed a prospective study including three groups. The group I is defined as adults with polycystic ovary syndrome and body mass index is greater than 25. The group II is defined as adults with polycystic ovary syndrome and body mass index is less than 25. The group III is defined as adults with non-polycystic ovary syndrome and body mass index is less than 25. The all three groups are compared considering their serum AMH levels,lipid profiles, sex steroids and glycemic analyses.', 'detailedDescription': 'In this study the investigators aimed to investigate whether there is a relation between body weight and serum anti mullerian hormone levels in adults with polycystic ovary syndrome. For this purpose the investigators designed a prospective study including three groups. The diagnosis of polycystic ovary syndrome was made in the presence of ;oligo- and/or anovulation,clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries. Clinical hyperandrogenism was defined by the presence of hirsutism , acne, or the presence of androgenic alopecia , biochemical hyperandrogenemia was defined as a serum level of total testosterone higher than 2.60 nmol/L, body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters. The patients were classified as obese with BMI ≥ 25 kg/m2 , adolescent patients were diagnosed 2 years after menarche in order to avoid the misdiagnosis of transitory functional hyperandrogenism and menstrual disorders during puberty. The all three groups are compared considering their serum AMH levels,lipid profiles, sex steroids and glycemic analyses.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The diagnosis of Polycystic ovary syndrome was made in the presence of ;oligo- and/or anovulation,clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries. Clinical hyperandrogenism was defined by the presence of hirsutism, acne, or the presence of androgenic alopecia , biochemical hyperandrogenemia was defined as a serum level of total testosterone higher than 2.60 nmol/L, body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters. The patients were classified as obese with BMI ≥ 25 kg/m2 , adolescent patients were diagnosed 2 years after menarche in order to avoid the misdiagnosis of transitory functional hyperandrogenism and menstrual disorders during puberty.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe participants with the following findings;oligo- and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries, presence in each ovary of 12 or more follicles measuring 2-9 mm in diameter and/or increased ovarian volume (\\> 10 mL).\n\nExclusion Criteria:\n\nThe participants with the following findings;pregnancy,breastfeeding,known liver disease or alanine aminotransferase (60 IU/l), creatinine (130 mmol/l), known alcohol abuse, diabetes mellitus and treatment with oral glucocorticoids or hormonal contraceptives.\n\nPatients could be included if hormonal contraception had been discontinued at least 1 month previously.'}, 'identificationModule': {'nctId': 'NCT01856894', 'briefTitle': 'Serum Anti-Mullerian Hormone (AMH) Levels in Overweight and Obese Adolescent Girls With Polycystic Ovaries', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Is Serum Anti-Mullerian Hormone (AMH) Level Associated With Body Weight, Glycemic and Lipidemic Markers in Adolescent Girls With Polycystic Ovaries?', 'orgStudyIdInfo': {'id': 'PCODHC'}}, 'contactsLocationsModule': {'locations': [{'zip': '34250', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Hüseyin Cengiz, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology'}, {'name': 'Cihan Kaya, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology'}, {'name': 'Şükrü Yıldız, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology'}, {'name': 'Hediye Dağdeviren, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}