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Completed

NCT Number: NCT06729359

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

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?

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) Adnexal Diseases BMI Body Weight Calculi Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Male Urogenital Diseases Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Stone, Urinary Thinness Underweight Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Al-Elwiya Maternity Teaching Hospital

Baghdad, Alrusafa, 10064, Iraq

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasonography of the abdomen and pelvis

Diagnostic Test

ultrasonography of the abdomen and pelvis using a 3.5mhz abdominal probe

Other names: 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

Primary outcomes

  1. 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

  1. the association between PCOS (Polycystic Ovary Syndrome) and BMI

    Time frame: at the time of enrollment

  2. the association between BMI and the presence of urinary tract stones

    Time frame: at the time of enrollment

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

    Time frame: at the time of enrollment

Sponsors and collaborators

Lead sponsor

Al-Kindy College of Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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