NCT06342180

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

March 26, 2024

Last Update Submit

March 26, 2024

Conditions

Keywords

polycystic ovary syndromeuric acid levelPCOS Subtypes

Outcome Measures

Primary Outcomes (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.

    Eight months

Study Arms (5)

Controls

Healthy controls between aged 18 and 35 years

Diagnostic Test: Serum uric acid level

PCOS Subtype 1

Hyperandrogenemia+oligoanovulation+PCO appearance on USG

Diagnostic Test: Serum uric acid level

PCOS Subtype 2

Hyperandrogenemia+oligoanovulation

Diagnostic Test: Serum uric acid level

PCOS Subtype 3

Hyperandrogenemia+ PCO appearance on USG

Diagnostic Test: Serum uric acid level

PCOS Subtype 4

Oligoanovulation+ PCO appearance on USG

Diagnostic Test: Serum uric acid level

Interventions

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.

ControlsPCOS Subtype 1PCOS Subtype 2PCOS Subtype 3PCOS Subtype 4

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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. -

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usak Egitim Ve Araştırma Hastanesi

Uşak, 64100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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 levels.

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. of medicine

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

January 1, 2022

Primary Completion

September 1, 2022

Study Completion

July 20, 2023

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations