Polycystic Ovary SyndromeNCT07441811
Urine Albumin/Creatinine Ratio and Renal Function Differences in Phenotypes of Polycystic Ovary Syndrome.
An observational study of Polycystic Ovary Syndrome and Urine Albumin \(UAlb\), run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
Since there are different metabolic effects in different phenotypes of polycystic ovary syndrome (PCOS); in this study; the investigators aimed to investigate whether there is a difference between glomerular filtration rate (eGFR) and urine albumin/creatinine ratio (ACR) levels in different PCOS phenotypes and compare… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Urine Albumin \(UAlb\), Urine Creatinine \(UCr\)
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 20 Jul 2023
- How long will I take part?
- 16 Months
- 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
- No healthy volunteers
- Adult
Study population: Woman aged between 18 and 35 years, age-matched between groups, diagnosed with PCOS and without cancer diagnosis, liver and kidney failure, not taking medications like ACEI and ARB\'s, 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 drugs, ACEIs and ARBs.
- Female patients without active infection will be included. -
Who cannot join
- Female patients \<18 years of age and \>35 years of age,
- Patients with known cancer, liver and kidney failure,
- Patients taking drugs, ACEIs and ARBs,
- Patients with active infection will not be included in the study. -
Trial locations and contacts
1 site in 1 country.
About this study
Since there are different metabolic effects in different phenotypes of polycystic ovary syndrome (PCOS); in this study; the investigators aimed to investigate whether there is a difference between glomerular filtration rate (eGFR) and urine albumin/creatinine ratio (ACR) levels in different PCOS phenotypes and compare healthy controls.
Read the detailed description
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. The diagnosis of this syndrome is made according to the revised 2003 Rotterdam 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 the absence of 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 the main characteristic 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 phenotypesof PCOS. Therefore, PCOS cases are divided into 4 phenotypes. These; phenotypes A has hyperandrogenemia + oligoanovulation + PCO appearance on ultrasonography (USG), phenotypes B has hyperandrogenemia + oligoanovulation, phenotypes C has hyperandrogenemia + PCO appearance on USG, and phenotypes D has oligoanovulation + PCO appearance on USG. As the phenotypesnumber of polycystic ovary syndrome decreases, the severity and frequency of metabolic disorders and inflammation accompanying polycystic ovary syndrome increase.
Polycystic ovary syndrome is associated with both subclinical low-grade inflammation, which may cause deterioration in renal functions in the long term, and metabolic disorders such as insulin resistance, dyslipidemia, glucose intolerance, hypertension and obesity, which may bring about glomerular filtration rate (GFR) changes. Additionally, increased urinary albumin/creatinine ratio (ACR) is a result of vascular leak and endothelial damage and is associated with increased cardiovascular risk. It has been suggested that the albumin-creatinine ratio in urine is increased in patients with polycystic ovary syndrome, and to detect the increased cardiovascular risk in patients with PCOS, the albumin/creatinine ratio in spot urine should be measured in these patients.
In this study, the investigators used different PCOS phenotypes; The investigators aimed to investigate whether there is a difference between GFR (eGFR) calculated from blood creatinine level and urinary ACR calculated from morning spot urine. Although there are studies on the renal functions of patients with PCOS in the literature review, as mentioned above, the number of studies evaluating renal complications in PCOS phenotypes is limited. The investigators aimed to contribute to the knowledge in this field with this study.
- Conditions
- Polycystic Ovary Syndrome, Urine Albumin \(UAlb\), Urine Creatinine \(UCr\), Glomerular Filtration Rate
- Keywords
- Polycystic ovary syndrome, PCOS Phenotypes, Urine albumin/creatinine ratio, Glomerular Filtration Rate
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Healthy controls between 18-35 years. | |
| PCOS Phenotype A | Hyperandrogenemia+oligoanovulation+PCO appearance on USG. | |
| PCOS Phenotype B | Hyperandrogenemia+oligoanovulation | |
| PCOS Phenotype C | Hyperandrogenemia+PCO appearance on USG. | |
| PCOS Phenotype D | Oligoanovulation+PCO appearance on USG. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine albumin/creatinine ratio
Urinary albumin-to-creatinine ratio (ACR) measured in morning spot urine samples (expressed in mg/g).
Measured: Eight months
glomerular filtration rate
Estimated glomerular filtration rate (eGFR) calculated from serum creatinine levels (expressed in mL/min/1.73 m²).
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Apr 2022
- Primary completion1 Sep 2022
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 16 Months
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441811
- Sponsor's protocol ID
- Usakpcos3
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2024
- Last updated
- 2 Mar 2026
- Results posted
- 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Albumin/Creatinine Ratio and Renal Function Differences in Phenotypes of Polycystic Ovary Syndrome.
- ClinicalTrials.gov ID
- NCT07441811
- Acronym / sponsor ID
- Usakpcos3
- Conditions
- Polycystic Ovary Syndrome, Urine Albumin \(UAlb\), Urine Creatinine \(UCr\), Glomerular Filtration Rate
- Keywords
- Polycystic ovary syndrome, PCOS Phenotypes, Urine albumin/creatinine ratio, Glomerular Filtration Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 2 Mar 2026 (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.
Since there are different metabolic effects in different phenotypes of polycystic ovary syndrome (PCOS); in this study; the investigators aimed to investigate whether there is a difference between glomerular filtration rate (eGFR) and urine albumin/creatinine ratio (ACR) levels in different PCOS phenotypes and compare healthy controls.
Detailed description
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. The diagnosis of this syndrome is made according to the revised 2003 Rotterdam 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 the absence of 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 the main characteristic 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 phenotypesof PCOS. Therefore, PCOS cases are divided into 4 phenotypes. These; phenotypes A has hyperandrogenemia + oligoanovulation + PCO appearance on ultrasonography (USG), phenotypes B has hyperandrogenemia + oligoanovulation, phenotypes C has hyperandrogenemia + PCO appearance on USG, and phenotypes D has oligoanovulation + PCO appearance on USG. As the phenotypesnumber of polycystic ovary syndrome decreases, the severity and frequency of metabolic disorders and inflammation accompanying polycystic ovary syndrome increase.
Polycystic ovary syndrome is associated with both subclinical low-grade inflammation, which may cause deterioration in renal functions in the long term, and metabolic disorders such as insulin resistance, dyslipidemia, glucose intolerance, hypertension and obesity, which may bring about glomerular filtration rate (GFR) changes. Additionally, increased urinary albumin/creatinine ratio (ACR) is a result of vascular leak and endothelial damage and is associated with increased cardiovascular risk. It has been suggested that the albumin-creatinine ratio in urine is increased in patients with polycystic ovary syndrome, and to detect the increased cardiovascular risk in patients with PCOS, the albumin/creatinine ratio in spot urine should be measured in these patients.
In this study, the investigators used different PCOS phenotypes; The investigators aimed to investigate whether there is a difference between GFR (eGFR) calculated from blood creatinine level and urinary ACR calculated from morning spot urine. Although there are studies on the renal functions of patients with PCOS in the literature review, as mentioned above, the number of studies evaluating renal complications in PCOS phenotypes is limited. The investigators aimed to contribute to the knowledge in this field with this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 16 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Healthy controls between 18-35 years. |
| PCOS Phenotype A | – | –Hyperandrogenemia+oligoanovulation+PCO appearance on USG. |
| PCOS Phenotype B | – | –Hyperandrogenemia+oligoanovulation |
| PCOS Phenotype C | – | –Hyperandrogenemia+PCO appearance on USG. |
| PCOS Phenotype D | – | –Oligoanovulation+PCO appearance on USG. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Woman aged between 18 and 35 years, age-matched between groups, diagnosed with PCOS and without cancer diagnosis, liver and kidney failure, not taking medications like ACEI and ARB\'s, and without active infection. -
Key inclusion criteria (5 listed)
- 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 drugs, ACEIs and ARBs.
- Female patients without active infection will be included. -
Key exclusion criteria (4 listed)
- Female patients \<18 years of age and \>35 years of age,
- Patients with known cancer, liver and kidney failure,
- Patients taking drugs, ACEIs and ARBs,
- Patients with active infection will not be included in the study. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urine albumin/creatinine ratio
Time frame: Eight months
Urinary albumin-to-creatinine ratio (ACR) measured in morning spot urine samples (expressed in mg/g).
glomerular filtration rate
Time frame: Eight months
Estimated glomerular filtration rate (eGFR) calculated from serum creatinine levels (expressed in mL/min/1.73 m²).
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 2 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Polycystic Ovary Syndrome and Urine Albumin \(UAlb\), 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 Mar 2026. 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?
Urine albumin/creatinine ratio (time frame: Eight months). The study lists 2 primary outcomes in all. 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 2 Mar 2026.