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

Completed

• Conditions: PCOS (Polycystic Ovary Syndrome); Stone, Urinary; BMI; Obesity; Overweight; Underweight

• Registration Number: NCT06729359
• Lead Sponsor: Al-Kindy College of Medicine

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-07
• Last Update Submitted: 2024-12-07
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 407

Inclusion Criteria

• female
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Al-Elwiya Maternity Teaching Hospital; 🇮🇶 Baghdad, Alrusafa, Iraq