PCOS (Polycystic Ovary Syndrome)NCT06729359
Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women
An observational study of PCOS (Polycystic Ovary Syndrome) and Stone, Urinary, run by Al-Kindy College of Medicine at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome), Stone, Urinary, BMI
- What is being tested?
- Ultrasonography of the abdomen and pelvis
- How many people
- 407 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2024to 15 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- female
- age 18-40 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Ultrasonography of the abdomen and pelvis
- Keywords
- PCOS (Polycystic Ovary Syndrome), stone, urinary, BMI, Obesity, Overweight, Underweight
- Medical subject headings
- Polycystic Ovary Syndrome, Urinary Calculi, Obesity, Overweight, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography of the abdomen and pelvisDiagnostic test
Also called tranveginal ultrasonography, serum testosterone, Serum dehydroepiandrosterone sulfate (DHEA-S), Serum androstenedione
ultrasonography of the abdomen and pelvis using a 3.5mhz abdominal probe
| Study group | Role | What they receive |
|---|---|---|
| PCOS (Polycystic Ovary Syndrome) group | includes patients diagnosed with PCOS (Polycystic Ovary Syndrome) Receives: 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) Receives: Diagnostic Test: Ultrasonography of the abdomen and pelvis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the association between PCOS (Polycystic Ovary Syndrome) and the presence of urinary tract stones controlled for BMI
Measured: at the time of enrollment
Secondary outcomes (3)
the association between PCOS (Polycystic Ovary Syndrome) and BMI
Measured: at the time of enrollment
the association between BMI and the presence of urinary tract stones
Measured: 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)
Measured: at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jul 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Kindy College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harth Mohamed Kamber, Al-Kindy College of Medicine
- Investigators
- Harth Mohamed Kamber, FICMS (Uro.), Study chair, University of Baghdad / Alkindy College of MedicineWeqar Akram Hussein, FICMS (Gyn.), Principal investigator, University of Baghdad / Alkindy College of MedicineZahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.), Principal investigator, University of Baghdad / Alkindy College of MedicineKamal Al-Jawdah, MBChB, MRCS, FIBMS, Study director, United Lincolnshire Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729359
- Sponsor's protocol ID
- 19 Al-KindyCM
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women
- ClinicalTrials.gov ID
- NCT06729359
- Acronym / sponsor ID
- 19 Al-KindyCM
- Conditions
- PCOS (Polycystic Ovary Syndrome), Stone, Urinary, BMI, Obesity, Overweight, Underweight
- Keywords
- PCOS (Polycystic Ovary Syndrome), stone, urinary, BMI, Obesity, Overweight, Underweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Al-Kindy College of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS (Polycystic Ovary Syndrome) group | – | Diagnostic Test: Ultrasonography of the abdomen and pelvisincludes patients diagnosed with PCOS (Polycystic Ovary Syndrome) |
| Contorol group | – | Diagnostic Test: Ultrasonography of the abdomen and pelvisinclude women of the same age group with no clinical or laboratory evidence of PCOS (Polycystic Ovary Syndrome) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- female
- age 18-40 years
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonography of the abdomen and pelvisAlso: tranveginal ultrasonography, serum testosterone, Serum dehydroepiandrosterone sulfate (DHEA-S), Serum androstenedioneultrasonography of the abdomen and pelvis using a 3.5mhz abdominal probe | Diagnostic test | Contorol group, PCOS (Polycystic Ovary Syndrome) group |
Primary outcome
the association between PCOS (Polycystic Ovary Syndrome) and the presence of urinary tract stones controlled for BMI
Time frame: at the time of enrollment
3 secondary outcomes
the association between PCOS (Polycystic Ovary Syndrome) and BMI
Time frame: at the time of enrollment
the association between BMI and the presence of urinary tract stones
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS (Polycystic Ovary Syndrome) and Stone, Urinary, run by Al-Kindy College of Medicine at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the association between PCOS (Polycystic Ovary Syndrome) and the presence of urinary tract stones controlled for BMI (time frame: at the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.