Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-11 @ 5:06 AM
Study NCT ID:
NCT03859856
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2019-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovarian Reserve in Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-25', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-02-28', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'E2, FSH, LH, AMH levels', 'timeFrame': 'during procedure', 'description': 'E2, FSH, LH, AMH levels of blood samples will be measured'}, {'measure': 'antral follicle count', 'timeFrame': 'during procedure', 'description': 'antral follicles of ovaries will be counted with ultrasonography'}, {'measure': 'ovarian volume', 'timeFrame': 'during procedure', 'description': 'both ovaries will be measured in three dimensions with ultrasonography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages including reproductive years. Hyperglycemic condition in diabetes can cause organ damage. This study aims to measure serum hormones including FSH, LH, E2, AMH, ovarian volume and antral follicle count (indicators of ovarian reserve) in women with and without type 1 diabetes mellitus.', 'detailedDescription': 'Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages including reproductive years. It is showed that hyperglycemic state in diabetes results in organ damage like kidneys and eyes. Ovarian reserve is important for the reproductive period. The measurements of serum hormones including follicle stimulating hormone (FSH), luteinizing hormone (LH), 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 diagnosed with type 1 diabetes mellitus and to compare them to healthy controls. Serum FSH, LH, E2 and AMH will be measured on the 3rd day of the cycle. Antral follicle count and ovarian volume measurement will be done with ultrasonography. Ovarian reserve markers will be compared between the groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be reproductive age women diagnosed with type 1 diabetes mellitus. The control population will be aged and BMI matched women without type 1 diabetes mellitus.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reproductive age group women: 18-40 years\n* Women diagnosed with type 1 diabetes (case group)\n* Women without type 1 diabetes (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'}, 'identificationModule': {'nctId': 'NCT03859856', 'briefTitle': 'Ovarian Reserve in Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Ovarian Reserve in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '2018.10.23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women with Type 1 diabetes mellitus', 'description': 'Reproductive age women diagnosed with type 1 diabetes mellitus', 'interventionNames': ['Other: hormone panel and ultrasonography']}, {'label': 'women without Type 1 diabetes mellitus', 'description': 'Reproductive age women diagnosed with type 1 diabetes mellitus to serve as control', 'interventionNames': ['Other: hormone panel and ultrasonography']}], 'interventions': [{'name': 'hormone panel and ultrasonography', 'type': 'OTHER', 'description': 'Blood sampling on the 3rd day of menstrual cycle for the measurement of serum FSH, LH, E2 and AMH hormone levels and ultrasonography for antral follicle count and ovarian volume measurement will be done.', 'armGroupLabels': ['women with Type 1 diabetes mellitus', 'women without Type 1 diabetes mellitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34150', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni SSTRH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md, ObGYN', 'investigatorFullName': 'Berna Aslan Cetin', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}