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

NCT06729359 | Completed

• 1 other identifier: 19 Al-KindyCM
• Study Type: observational
• Target: 407
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Keywords

PCOS (Polycystic Ovary Syndrome); stone, urinary; BMI; Obesity; Overweight; Underweight

Outcome Measures

Primary Outcomes (1)

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

  at the time of enrollment

Secondary Outcomes (3)

• 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 Arms (2)

PCOS (Polycystic Ovary Syndrome) group

includes patients diagnosed with PCOS (Polycystic Ovary Syndrome)

Diagnostic Test: Ultrasonography of the abdomen and pelvis

Contorol group

include women of the same age group with no clinical or laboratory evidence of PCOS (Polycystic Ovary Syndrome)

Diagnostic Test: Ultrasonography of the abdomen and pelvis

Interventions

Ultrasonography of the abdomen and pelvis DIAGNOSTIC_TEST

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

Also known as: 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

Contorol group; PCOS (Polycystic Ovary Syndrome) group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• female
• age 18-40 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Kindy College of Medicine: lead

Study Sites (1)

Al-Elwiya Maternity Teaching Hospital

Baghdad, Alrusafa, 10064, Iraq

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Urinary Calculi; Obesity; Overweight; Thinness

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Urolithiasis; Urologic Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Harth Mohamed Kamber, FICMS (Uro.)

  University of Baghdad / Alkindy College of Medicine

  STUDY CHAIR

• Weqar Akram Hussein, FICMS (Gyn.)

  University of Baghdad / Alkindy College of Medicine

  PRINCIPAL INVESTIGATOR

• Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.)

  University of Baghdad / Alkindy College of Medicine

  PRINCIPAL INVESTIGATOR

• Kamal Al-Jawdah, MBChB, MRCS, FIBMS

  United Lincolnshire Teaching Hospitals NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant proffessor, Consultant utologist

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 11, 2024
• Study Start: July 1, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

IR (1)