Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 5:11 PM
Study NCT ID:
NCT06729359
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2024-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D013851', 'term': 'Thinness'}], '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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-07', 'studyFirstSubmitDate': '2024-12-07', 'studyFirstSubmitQcDate': '2024-12-07', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the association between PCOS (Polycystic Ovary Syndrome) and the presence of urinary tract stones controlled for BMI', 'timeFrame': 'at the time of enrollment'}], 'secondaryOutcomes': [{'measure': 'the association between PCOS (Polycystic Ovary Syndrome) and BMI', 'timeFrame': 'at the time of enrollment'}, {'measure': 'the association between BMI and the presence of urinary tract stones', 'timeFrame': 'at the time of enrollment'}, {'measure': 'the association between BMI and the presence of urinary tract stones controlled for the presence of PCOS (Polycystic Ovary Syndrome)', 'timeFrame': 'at the time of enrollment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS (Polycystic Ovary Syndrome)', 'stone, urinary', 'BMI', 'Obesity', 'Overweight', 'Underweight'], 'conditions': ['PCOS (Polycystic Ovary Syndrome)', 'Stone, Urinary', 'BMI', 'Obesity', 'Overweight', 'Underweight']}, 'descriptionModule': {'briefSummary': 'The goal of this observational case-control study is to find out the impact of PCOS as a risk factor for the presence of urinary tract stones taking into account the BMI of women aged 18-40 years consulting the gynecology and obstetrics outpatient clinic at Al-Elwiya Maternity Teaching Hospital.\n\nThe study aims to collect information from approximately 200 women with polycystic ovary syndrome and 200 volunteers who do not have PCOS.\n\nA written consent was obtained from all the participants. The information collected included age, weight, and height. In addition, focused history and clinical examination were conducted for all patients, and for some patients, one or more additional blood tests were obtained. The additional tests included but not limited to serum levels of testosterone, dehydroepiandrosterone sulfate (DHEA-S), androstenedione, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and sex hormone-binding globulin. Moreover, ultrasonography of the abdomen and pelvis was obtained for all patients as part of the diagnosis of PCOS and as screening for urinary tract stones. Also, transvaginal ultrasonography was obtained for some patients according to the individual condition as requested by the treating gynecologist. The diagnosis ofc PCOS was based on the Rotterdam criteria. (1)\n\nThe main questions the study aims to answer are:\n\n* Is PCOS a risk factor for urinary tract stones when taking BMI into account?\n* Is PCOS a risk for urinary tract stones at all?\n* Is there an association between PCOS and BMI?\n* Does BMI affect the presence of urinary tract stones at all and the presence of urinary tract stones when taking PCOS into account?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the study recruited two groups of females attending the gynecology and obstetrics outpatient clinic at Al-Elwiya Maternity Teaching Hospital. the first group contains women diagnosed with PCOS (Polycystic Ovary Syndrome) and the second group contains normal women attending the clinic for other causes that do not affect the body weight or the hormonal balance of the body', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* age 18-40 years\n\nExclusion Criteria:\n\n* A medical or surgical condition that affects urinary tract stone formation.\n* A medical or surgical condition that affects body weight or height.\n* A medical or surgical condition that affects hormonal balance.'}, 'identificationModule': {'nctId': 'NCT06729359', 'briefTitle': 'Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women', 'organization': {'class': 'OTHER', 'fullName': 'Al-Kindy College of Medicine'}, 'officialTitle': 'Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women', 'orgStudyIdInfo': {'id': '19 Al-KindyCM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCOS (Polycystic Ovary Syndrome) group', 'description': 'includes patients diagnosed with PCOS (Polycystic Ovary Syndrome)', 'interventionNames': ['Diagnostic Test: Ultrasonography of the abdomen and pelvis']}, {'label': 'Contorol group', 'description': 'include women of the same age group with no clinical or laboratory evidence of PCOS (Polycystic Ovary Syndrome)', 'interventionNames': ['Diagnostic Test: Ultrasonography of the abdomen and pelvis']}], 'interventions': [{'name': 'Ultrasonography of the abdomen and pelvis', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['tranveginal ultrasonography', 'serum testosterone', 'Serum dehydroepiandrosterone sulfate (DHEA-S)', 'Serum androstenedione', 'Serum , luteinizing hormone (LH)', 'Serum follicle-stimulating hormone (FSH)', 'Serum sex hormone-binding globulin'], 'description': 'ultrasonography of the abdomen and pelvis using a 3.5mhz abdominal probe', 'armGroupLabels': ['Contorol group', 'PCOS (Polycystic Ovary Syndrome) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10064', 'city': 'Baghdad', 'state': 'Alrusafa', 'country': 'Iraq', 'facility': 'Al-Elwiya Maternity Teaching Hospital', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'Harth Mohamed Kamber, FICMS (Uro.)', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Baghdad / Alkindy College of Medicine'}, {'name': 'Weqar Akram Hussein, FICMS (Gyn.)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Baghdad / Alkindy College of Medicine'}, {'name': 'Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Baghdad / Alkindy College of Medicine'}, {'name': 'Kamal Al-Jawdah, MBChB, MRCS, FIBMS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'United Lincolnshire Teaching Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Kindy College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant proffessor, Consultant utologist', 'investigatorFullName': 'Harth Mohamed Kamber', 'investigatorAffiliation': 'Al-Kindy College of Medicine'}}}}