Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women
NCT ID: NCT06729359
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
407 participants
OBSERVATIONAL
2024-07-01
2024-11-15
Brief Summary
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The study aims to collect information from approximately 200 women with polycystic ovary syndrome and 200 volunteers who do not have PCOS.
A 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)
The main questions the study aims to answer are:
* Is PCOS a risk factor for urinary tract stones when taking BMI into account?
* Is PCOS a risk for urinary tract stones at all?
* Is there an association between PCOS and BMI?
* Does BMI affect the presence of urinary tract stones at all and the presence of urinary tract stones when taking PCOS into account?
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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PCOS (Polycystic Ovary Syndrome) group
includes patients diagnosed with PCOS (Polycystic Ovary Syndrome)
Ultrasonography of the abdomen and pelvis
ultrasonography of the abdomen and pelvis using a 3.5mhz abdominal probe
Contorol group
include women of the same age group with no clinical or laboratory evidence of PCOS (Polycystic Ovary Syndrome)
Ultrasonography of the abdomen and pelvis
ultrasonography of the abdomen and pelvis using a 3.5mhz abdominal probe
Interventions
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Ultrasonography of the abdomen and pelvis
ultrasonography of the abdomen and pelvis using a 3.5mhz abdominal probe
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-40 years
Exclusion Criteria
* A medical or surgical condition that affects body weight or height.
* A medical or surgical condition that affects hormonal balance.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Al-Kindy College of Medicine
OTHER
Responsible Party
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Harth Mohamed Kamber
Assistant proffessor, Consultant utologist
Principal Investigators
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Harth Mohamed Kamber, FICMS (Uro.)
Role: STUDY_CHAIR
University of Baghdad / Alkindy College of Medicine
Weqar Akram Hussein, FICMS (Gyn.)
Role: PRINCIPAL_INVESTIGATOR
University of Baghdad / Alkindy College of Medicine
Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.)
Role: PRINCIPAL_INVESTIGATOR
University of Baghdad / Alkindy College of Medicine
Kamal Al-Jawdah, MBChB, MRCS, FIBMS
Role: STUDY_DIRECTOR
United Lincolnshire Teaching Hospitals NHS Trust
Locations
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Al-Elwiya Maternity Teaching Hospital
Baghdad, Alrusafa, Iraq
Countries
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Other Identifiers
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19 Al-KindyCM
Identifier Type: -
Identifier Source: org_study_id