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

December 7, 2024 updated by: Harth Mohamed Kamber, Al-Kindy College of Medicine

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

407

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCOS (Polycystic Ovary Syndrome) group
includes patients diagnosed with PCOS (Polycystic Ovary Syndrome)
Diagnostic test: Ultrasonography of the abdomen and pelvis
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the association between PCOS (Polycystic Ovary Syndrome) and the presence of urinary tract stones controlled for BMI
Time Frame: at the time of enrollment
at the time of enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
the association between PCOS (Polycystic Ovary Syndrome) and BMI
Time Frame: at the time of enrollment
at the time of enrollment
the association between BMI and the presence of urinary tract stones
Time Frame: at the time of enrollment
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)
Time Frame: at the time of enrollment
at the time of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Kindy College of Medicine

Investigators

  • Study Chair: Harth Mohamed Kamber, FICMS (Uro.), 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: Weqar Akram Hussein, FICMS (Gyn.), University of Baghdad / Alkindy College of Medicine
  • Study Director: Kamal Al-Jawdah, MBChB, MRCS, FIBMS, United Lincolnshire Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

November 15, 2024

Study Registration Dates

First Submitted

December 7, 2024

First Submitted That Met QC Criteria

December 7, 2024

First Posted (Estimated)

December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 7, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19 Al-KindyCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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