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Uric Acid Concentration, Serum, Quantitative Trait Locus 7NCT06342180

Metabolic Differences Between Subtypes of Polycystic Ovary Syndrome

An observational study of Uric Acid Concentration, Serum, Quantitative Trait Locus 7 and Polycystic Ovary Syndrome, run by Uşak University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We aimed to investigate serum uric acid levels in patients with different phenotype of policystic ovary syndrome and to compare healthy controls. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
What is being tested?
Serum uric acid level
How many people
300 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2022to 20 Jul 2023
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 35 years
  • Women only
  • Adult

Study population: Women aged between 18 and 35, age-matched between groups, diagnosed with PCOS and without a known cancer diagnosis, liver and kidney failure, not taking medications that would affect uric acid levels, and without active infection.

Who may be able to join

  • Patients who applied for reasons such as hair growth, acne, menstrual irregularity or infertility and were diagnosed with PCOS after examination, biochemical, hormonal and sonographic tests,
  • Female patients between the ages of 18-35,
  • Patients without known cancer, liver or kidney failure,
  • Patients who do not take medications that will affect uric acid levels,
  • Female patients without active infection will be included. -

Who cannot join

  • Female patients under eighteen years of age and \>35 years of age,
  • Patients with known cancer, liver and kidney failure,
  • Patients taking medications that will affect uric acid levels,
  • Patients with active infection will be excluded. -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Usak Egitim Ve Araştırma Hastanesi

    Uşak, 64100

Other trials in Turkey (Türkiye)

About this study

Official title: Serum Uric Acid Levels in Polycystic Ovary Syndrome Subtypes.

We aimed to investigate serum uric acid levels in patients with different phenotype of policystic ovary syndrome and to compare healthy controls.

Read the detailed description

The final breakdown product of adenosine and guanosine-based purines formed as a result of the breakdown of nucleic acids is uric acid (UA). Uric acid has many beneficial and harmful properties for humans. One of the most important benefits of uric acid is that it can act as an antioxidant and is perhaps one of the most important antioxidants in plasma. However, this hypothesis is completely opposite to the hypothesis advocating an increase in the incidence of hyperuricemia and cardiovascular events. There are also experimental studies showing that UA, which has an antioxidant effect in the extracellular fluid, has harmful effects when it enters the cell. Uric acid can contribute to molecular endothelial dysfunction, oxidative stress and the formation of many oxygen radicals, disruption of the vasodilation mechanism, and increased inflammation. A correlation has been found between insulin resistance and serum UA level in patients with metabolic syndrome. It has been reported in some studies that hyperuricemia can be considered as an indicator of insulin resistance in these patients. At the same time, many studies have reported that both insulin resistance and hyperuricemia increase cardiovascular risk. In a study, it was stated that every 1 mg/dL increase in serum UA level in women increased the risk of ischemic heart disease by 12%.

Polycystic ovary syndrome (PCOS) is one of the endocrinological diseases that affects 5-20% of women of reproductive age. It is characterized by oligoanovulation, clinical or biochemical hyperandrogenemia and the appearance of polycystic ovaries. This syndrome is diagnosed according to the revised 2003 Rotterdan criteria; These criteria; 1) Oligo-anovulation, 2) Clinical and/or biochemical hyperandrogenism findings, 3) Polycystic ovary (PCO) appearance in the ovaries. For diagnosis, it is sufficient to have two of these criteria and not have another disease that causes this.

Polycystic ovary syndrome; Metabolic disorders such as insulin resistance, dyslipidemia, glucose intolerance, hypertension and obesity are often accompanied, and increased inflammation is one of the main characteristics of this syndrome. While the presence or absence of PCOS was important until recently, recent studies have shown that metabolic changes and inflammation occur at different degrees in different subtypes of PCOS. Therefore, PCOS cases are divided into 4 subtypes. These; Subtype 1 has hyperandrogenemia + oligoanovulation + PCO appearance on ultrasonography (USG), Subtype 2 has hyperandrogenemia + oligoanovulation, Subtype 3 has hyperandrogenemia + PCO appearance on USG, and Subtype 4 has oligoanovulation + PCO appearance on USG. As the subtype number of polycystic ovary syndrome decreases, the severity and frequency of metabolic disorders and inflammation accompanying polycystic ovary syndrome increase.

Hyperuricemia is one of the common metabolic disorders in patients with PCOS. Prevalence studies have shown that the frequency of hyperuricemia in patients with PCOS is approximately 25%, 3 times higher than in controls. However, these studies were conducted in the general PCOS patient group, and patients with different subtypes were not evaluated.

Since there are different metabolic effects in different subtypes of polycystic ovary syndrome; In this study we aimed to investigate whether there is a difference between serum UA levels in different PCOS subtypes. Studies investigating UA levels in subtypes of PCOS are rare in the literature. We aim to contribute to the knowledge in this field with the results we obtained from this study.

Being tested
Serum uric acid level
Keywords
polycystic ovary syndrome, uric acid level, PCOS Subtypes
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serum uric acid levelDiagnostic test

    An amount of 2-3 ml of blood sample will be collected from the patients after 8-12 hours of fasting and will be kept frozen at -70 degrees to calculate the serum UA level.

Study groups in NCT06342180
Study groupRoleWhat they receive
ControlsHealthy controls between aged 18 and 35 years
Receives: Diagnostic Test: Serum uric acid level
PCOS Subtype 1Hyperandrogenemia+oligoanovulation+PCO appearance on USG
Receives: Diagnostic Test: Serum uric acid level
PCOS Subtype 2Hyperandrogenemia+oligoanovulation
Receives: Diagnostic Test: Serum uric acid level
PCOS Subtype 3Hyperandrogenemia+ PCO appearance on USG
Receives: Diagnostic Test: Serum uric acid level
PCOS Subtype 4Oligoanovulation+ PCO appearance on USG
Receives: Diagnostic Test: Serum uric acid level

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uric acid levels in PCOS subtypes

    Since there are different metabolic effects in different subtypes of polycystic ovary syndrome; In this study we aimed to investigate whether there is a difference between serum UA levels in different PCOS subtypes and the difference between these subtypes and the healthy group.

    Measured: Eight months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start1 Jan 2022
  3. Primary completion1 Sep 2022
  4. Study completion20 Jul 2023

Resources

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
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342180
Sponsor's protocol ID
Usakupcos1
Status last verified
Mar 2024
First submitted
26 Mar 2024
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Akkus C, Oner O, Okan Kilic A, Ucar Toros M, Duran C. Serum uric acid levels in patients with different phenotypes of polycystic ovary syndrome. Indian J Med Res. 2025 Dec;162(6):856-862. doi: 10.25259/IJMR_1903_2025.

    PubMed 41648982

Questions about this trial

What is this clinical trial studying?

An observational study of Uric Acid Concentration, Serum, Quantitative Trait Locus 7 and Polycystic Ovary Syndrome, run by Uşak University at 1 site in Turkey (Türkiye).

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 5 inclusion and 4 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 2 Apr 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 Turkey (Türkiye). 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?

Uric acid levels in PCOS subtypes (time frame: Eight months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06342180, which also lists 1 linked publication.

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 2 Apr 2024.

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