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CompletedNCT06729359Updated Dec 11, 2024

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

An observational study in PCOS (Polycystic Ovary Syndrome), Stone, Urinary and BMI, sponsored by Al-Kindy College of Medicine. Completed at 1 site in Iraq. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by Al-Kindy College of Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
407
Ages
18 Years to 40 Years
Sex
Female
01

Study 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?
02

Conditions studied

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

Keywords

  • PCOS (Polycystic Ovary Syndrome)
  • stone, urinary
  • BMI
  • Obesity
  • Overweight
  • Underweight
03

In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's enrollment of 407 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Al-Kindy College of Medicine is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • female
  • age 18-40 years

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
407 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testUltrasonography of the abdomen and pelvis

    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

06

What researchers measure

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

07

Study locations

1 site
  • Al-Elwiya Maternity Teaching Hospital
    Baghdad, Alrusafa 10064, Iraq
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06729359
Lead sponsor
Al-Kindy College of Medicine
Responsible party
Harth Mohamed Kamber (Assistant proffessor, Consultant utologist, Al-Kindy College of Medicine) — Principal investigator
First posted
Dec 11, 2024
Start date
Jul 1, 2024
Primary completion
Nov 15, 2024
Completion
Nov 15, 2024
Last update
Dec 11, 2024

Study contacts

Harth Mohamed Kamber, FICMS (Uro.)
study chair · University of Baghdad / Alkindy College of Medicine
Weqar Akram Hussein, FICMS (Gyn.)
principal investigator · University of Baghdad / Alkindy College of Medicine
Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.)
principal investigator · University of Baghdad / Alkindy College of Medicine
Kamal Al-Jawdah, MBChB, MRCS, FIBMS
study director · United Lincolnshire Teaching Hospitals NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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