Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-29 @ 1:30 PM
Study NCT ID:
NCT05418595
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2022-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic Evaluation of Ovarian Stromal Vascularity in Women With Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010048', 'term': 'Ovarian Cysts'}], 'ancestors': [{'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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-18', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The superiority of Superb microvascular imaging doppler technique over the conventional doppler techniques', 'timeFrame': '1 month', 'description': 'The Toshiba Aplio 500 ultrasonography tool (Toshiba, Aplio 500, Tokyo, Japan) was used in the Radiology Policlinic Ultrasonography Unit to perform ultrasonography using a 1-6 MHz convex probe. After scanning the lesion with TAUSG, 5-12 second-long video pictures were recorded. The ovarian stromal vascularity was defined according to the International Ovarian Tumor Analysis (IOTA) group criteria. Four categories of endometrial blood flow were identified: No coloration in grade 1, one or more punctate colorations in grade 2, one linear coloring or several (\\>5) punctate colorations in grade 3, and multiple linear colorations in grade 4 of the ovary. \\[14\\]. The vascularization rating was done independently using CDI, PDI, cSMI, and mSMI techniques. In all patients, the ovarian morphologic features were recorded for the both ovaries. Three radiologists analyzed the captured video pictures and assigned a consensus rating.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cysts']}, 'referencesModule': {'references': [{'pmid': '25558942', 'type': 'BACKGROUND', 'citation': 'Ozdemir O, Sari ME, Kalkan D, Koc EM, Ozdemir S, Atalay CR. Comprasion of ovarian stromal blood flow measured by color Doppler ultrasonography in polycystic ovary syndrome patients and healthy women with ultrasonographic evidence of polycystic. Gynecol Endocrinol. 2015 Apr;31(4):322-6. doi: 10.3109/09513590.2014.995617. Epub 2015 Jan 5.'}, {'pmid': '24196302', 'type': 'BACKGROUND', 'citation': 'Makled AK, El Sherbiny M, Elkabarity R. Assessment of ovarian stromal blood flow after metformin treatment in women with polycystic ovary syndrome. Arch Gynecol Obstet. 2014 Apr;289(4):883-91. doi: 10.1007/s00404-013-3057-8. Epub 2013 Nov 7.'}]}, 'descriptionModule': {'briefSummary': 'The most common endocrine condition in reproductive women is polycystic ovary syndrome. It has a prevalence of 5-10%. According to the Rotterdam criteria, oligo/anovulation, clinic or biochemical hyperandrogenism, PCOS morphology in ultrasonography, and the presence of these two criteria are required for diagnosis.\n\nThe echogenicity of the ovarian stroma, vascularity, ovarian size, cystic pattern density, and subcortical organization of cysts are all significant considerations in ultrasonographic evaluation.', 'detailedDescription': "Retrospective archive study.\n\nIn the years 2018-2019, the ultrasonographic archives of PCOS women will be analyzed retrospectively in the Radiology department of Usak Education and Research Hospital. Ultrasonographic (Two-dimensional ultrasonography , conventional and other doppler) measurements of ovaries will be assessed in ultrasonographic data. Patient's data ( Menstrual cycle, androgenic findings, age, BMI etc..) will be obtained on the hospital records, PCOS patient's phenotype will be evaluated according to National Institutes Health (NIH) recommendations.\n\nThe ovarian ultrasonographic findings of PCOS women will be compared.\n\nThis study approved by Usak University Medical Faculty Ethical Committee April,06,2022.\n\nThe Ethical Committee decision number is 57-57-04."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Reproductive period, PCOS women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reproductive period According to Rotterdam criteria PCOS women.\n\nExclusion Criteria:\n\nWomen have not PCOS criteria, Non-reproductive period Pregnancy Postpartum Ovarian mass Underwent ovarian surgery.'}, 'identificationModule': {'nctId': 'NCT05418595', 'briefTitle': 'Ultrasonographic Evaluation of Ovarian Stromal Vascularity in Women With Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'Usak State Hospital'}, 'officialTitle': 'Ultrasonographic Evaluation of Ovarian Stroma in PCOS Women', 'orgStudyIdInfo': {'id': '575704'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group-1', 'description': 'PCOS patients intraovarian stromal conventional and SMI doppler findings'}], 'interventions': [{'type': 'OTHER', 'armGroupLabels': ['Group-1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uşak', 'country': 'Turkey (Türkiye)', 'facility': 'İrem Şenyuva', 'geoPoint': {'lat': 38.67351, 'lon': 29.4058}}], 'overallOfficials': [{'name': 'İrem Şenyuva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USAK TRAINING AND RESEARCH HOSPITAL, DEPARTMENT OF OBSTETRICS AND GYNECOLOGY,TURKEY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Usak State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Usak Training and Research hospital', 'investigatorFullName': 'Irem Senyuva', 'investigatorAffiliation': 'Usak State Hospital'}}}}