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Clinical Trials/NCT06729359
NCT06729359
Completed
Not Applicable

Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women

Al-Kindy College of Medicine1 site in 1 country407 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PCOS (Polycystic Ovary Syndrome)
Sponsor
Al-Kindy College of Medicine
Enrollment
407
Locations
1
Primary Endpoint
the association between PCOS (Polycystic Ovary Syndrome) and the presence of urinary tract stones controlled for BMI
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

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?
Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
November 15, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Harth Mohamed Kamber

Assistant proffessor, Consultant utologist

Al-Kindy College of Medicine

Eligibility Criteria

Inclusion Criteria

  • age 18-40 years

Exclusion Criteria

  • A medical or surgical condition that affects urinary tract stone formation.
  • A medical or surgical condition that affects body weight or height.
  • A medical or surgical condition that affects hormonal balance.

Outcomes

Primary Outcomes

the association between PCOS (Polycystic Ovary Syndrome) and the presence of urinary tract stones controlled for BMI

Time Frame: at the time of enrollment

Secondary Outcomes

  • the association between PCOS (Polycystic Ovary Syndrome) and BMI(at the time of enrollment)
  • the association between BMI and the presence of urinary tract stones(at the time of enrollment)
  • the association between BMI and the presence of urinary tract stones controlled for the presence of PCOS (Polycystic Ovary Syndrome)(at the time of enrollment)

Study Sites (1)

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