Polycystic Ovary SyndromePMOS-FRNCT07844785
Metabolic and Hormonal Parameters in Women With Polyendocrine Metabolic Ovarian Syndrome
An observational study of Polycystic Ovary Syndrome and Polycystic Ovary Syndrome (PCOS) Women, run by Istinye University.
Trial summary
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a common endocrine and metabolic disorder associated with insulin resistance, hyperandrogenism, and an increased risk of long-term metabolic complications. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Polycystic Ovary Syndrome (PCOS) Women, Fetuin-A
- What is being tested?
- Blood and Saliva Biomarker Assessment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Study population: Women aged 18-35 years with Polyendocrine Metabolic Ovarian Syndrome (PMOS) and age-matched healthy women recruited from the outpatient gynecology and endocrinology clinics of Istinye University. Participants will undergo clinical evaluation and fasting blood and unstimulated saliva collection for biochemical analyses.
Who may be able to join
- PMOS Group:
- Female, aged 18-35 years
- Diagnosis of Polyendocrine Metabolic Ovarian Syndrome (PMOS) according to the Rotterdam criteria
- BMI <30 kg/m²
- Written informed consent
- Healthy Control Group:
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- Female, aged 18-35 years
- Regular menstrual cycles
- No diagnosis of PMOS
- BMI <30 kg/m²
- Written informed consent
Who cannot join
- Pregnancy or breastfeeding
- Diabetes mellitus
- Chronic kidney or liver disease
- Thyroid dysfunction
- Hyperprolactinemia
- Cushing syndrome
Show all 9Show fewer
- Non-classic congenital adrenal hyperplasia
- Use of hormonal contraceptives, anti-androgens, glucocorticoids, metformin, or insulin-sensitizing medications within the previous 3 months
- Severe periodontal disease or active oral infection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Correlation of Serum and Salivary Fetuin-A and Resistin Levels With Metabolic and Hormonal Parameters in Women With Polyendocrine Metabolic Ovarian Syndrome
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a common endocrine and metabolic disorder associated with insulin resistance, hyperandrogenism, and an increased risk of long-term metabolic complications. Fetuin-A and resistin are adipokines implicated in insulin resistance and chronic inflammation and may serve as potential biomarkers for metabolic dysfunction in women with PMOS.
This prospective observational case-control study aims to compare serum and salivary Fetuin-A and resistin levels between women with PMOS and healthy controls. The study will evaluate the correlation between serum and salivary biomarker concentrations and investigate their associations with insulin resistance, lipid profile, and hormonal parameters. The findings may help determine whether salivary measurements can serve as reliable non-invasive biomarkers for the diagnosis and metabolic assessment of PMOS.
Read the detailed description
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a complex endocrine disorder characterized by reproductive, metabolic, and hormonal abnormalities. Insulin resistance, chronic low-grade inflammation, and hyperandrogenism play central roles in its pathophysiology. Identifying reliable and non-invasive biomarkers may improve early diagnosis, metabolic risk assessment, and long-term clinical follow-up.
Fetuin-A is a glycoprotein involved in insulin signaling and glucose metabolism, whereas resistin is a pro-inflammatory adipokine associated with insulin resistance and metabolic dysfunction. Previous studies evaluating serum concentrations of these biomarkers in women with PMOS have reported inconsistent findings, and little is known about whether salivary concentrations accurately reflect serum levels.
This prospective observational case-control study will enroll 80 women aged 18-35 years, including 40 women diagnosed with PMOS according to the Rotterdam criteria and 40 age-matched healthy controls. Fasting blood and unstimulated saliva samples will be collected simultaneously. Serum and salivary Fetuin-A and resistin concentrations will be measured using enzyme-linked immunosorbent assay (ELISA). Metabolic and hormonal parameters, including fasting glucose, fasting insulin, HbA1c, lipid profile, total testosterone, sex hormone-binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), and the free androgen index (FAI), will also be evaluated.
The primary objective is to determine the correlation between serum and salivary Fetuin-A and resistin levels. Secondary objectives include evaluating associations between these biomarkers and insulin resistance, lipid profile, anthropometric measurements, and hormonal parameters, as well as assessing the potential utility of salivary biomarkers as non-invasive tools for the metabolic evaluation of women with PMOS.
- Conditions
- Polycystic Ovary Syndrome, Polycystic Ovary Syndrome (PCOS) Women, Fetuin-A, Serum Biomarkers, Insulin Resistance
- Being tested
- Blood and Saliva Biomarker Assessment
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and Saliva Biomarker AssessmentDiagnostic test
Participants will provide fasting venous blood and unstimulated saliva samples for measurement of Fetuin-A and resistin concentrations using enzyme-linked immunosorbent assay (ELISA). Metabolic and hormonal parameters, including fasting glucose, fasting insulin, HbA1c, lipid profile, total testosterone, sex hormone-binding globulin (SHBG), and dehydroepiandrosterone sulfate (DHEAS), will also be assessed. No therapeutic intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| PMOS Group | Women aged 18 to 35 years diagnosed with Polyendocrine Metabolic Ovarian Syndrome according to the Rotterdam criteria. Participants will undergo clinical and anthropometric evaluation, and fasting serum and unstimulated saliva samples will be collected for Fetuin-A, resistin, metabolic, and hormonal measurements. Receives: Diagnostic Test: Blood and Saliva Biomarker Assessment | |
| Healthy Control Group | Women aged 18 to 35 years with regular menstrual cycles and without Polyendocrine Metabolic Ovarian Syndrome. Participants will undergo the same clinical, anthropometric, serum, and saliva assessments as the PMOS group. Receives: Diagnostic Test: Blood and Saliva Biomarker Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Serum and Salivary Fetuin-A and Resistin Levels
To determine the correlation between serum and salivary Fetuin-A and resistin concentrations in women with Polyendocrine Metabolic Ovarian Syndrome (PMOS) and healthy controls.
Measured: At baseline (Day 1)
Secondary outcomes (15)
Serum Fetuin-A Levels
Comparison of serum Fetuin-A concentrations between women with PMOS and healthy controls.
Measured: Baseline
Salivary Fetuin-A Levels
Comparison of salivary Fetuin-A concentrations between women with PMOS and healthy controls
Measured: Baseline
Serum Resistin Levels
Comparison of serum resistin concentrations between women with PMOS and healthy controls.
Measured: Baseline
Salivary Resistin Levels
Comparison of salivary resistin concentrations between women with PMOS and healthy controls.
Measured: Baseline
Correlation Between Fetuin-A and Resistin Concentrations and HOMA-IR
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with HOMA-IR. HOMA-IR will be calculated from fasting glucose and fasting insulin concentrations. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Correlation Between Fetuin-A and Resistin Concentrations and SHBG Concentration
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum sex hormone-binding globulin (SHBG) concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Correlation of Fetuin-A and Resistin Concentrations With DHEAS Concentration
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum dehydroepiandrosterone sulfate (DHEAS) concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Correlation of Fetuin-A and Resistin Concentrations With Free Androgen Index
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with the Free Androgen Index (FAI), calculated as (total testosterone / SHBG) × 100. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Correlation of Fetuin-A and Resistin Concentrations With Total Cholesterol Concentration
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum [total cholesterol / LDL cholesterol / HDL cholesterol / triglyceride] concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Correlation of Fetuin-A and Resistin Concentrations With LDL Cholesterol Concentration
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum [total cholesterol / LDL cholesterol / HDL cholesterol / triglyceride] concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Correlation of Fetuin-A and Resistin Concentrations With HDL Cholesterol Concentration
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum [total cholesterol / LDL cholesterol / HDL cholesterol / triglyceride] concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Correlation of Fetuin-A and Resistin Concentrations With Triglyceride Concentration
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum [total cholesterol / LDL cholesterol / HDL cholesterol / triglyceride] concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Correlation Between Fetuin-A and Resistin Concentrations and Total Testosterone Concentration
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum total testosterone concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Correlation Between Fetuin-A and Resistin Concentrations and DHEAS Concentration
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum dehydroepiandrosterone sulfate (DHEAS) concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Correlation Between Fetuin-A and Resistin Concentrations and Free Androgen Index
Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with the Free Androgen Index (FAI), calculated as (total testosterone / SHBG) × 100. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844785
- Sponsor's protocol ID
- ISU-PMOS-01
- Acronym
- PMOS-FR
- Status last verified
- Jul 2026
- First submitted
- 10 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Serum and Salivary Fetuin-A and Resistin Levels With Metabolic and Hormonal Parameters in Women With Polyendocrine Metabolic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT07844785
- Acronym / sponsor ID
- PMOS-FR / ISU-PMOS-01
- Conditions
- Polycystic Ovary Syndrome, Polycystic Ovary Syndrome (PCOS) Women, Fetuin-A, Serum Biomarkers, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 28 Sep 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.
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a common endocrine and metabolic disorder associated with insulin resistance, hyperandrogenism, and an increased risk of long-term metabolic complications. Fetuin-A and resistin are adipokines implicated in insulin resistance and chronic inflammation and may serve as potential biomarkers for metabolic dysfunction in women with PMOS.
This prospective observational case-control study aims to compare serum and salivary Fetuin-A and resistin levels between women with PMOS and healthy controls. The study will evaluate the correlation between serum and salivary biomarker concentrations and investigate their associations with insulin resistance, lipid profile, and hormonal parameters. The findings may help determine whether salivary measurements can serve as reliable non-invasive biomarkers for the diagnosis and metabolic assessment of PMOS.
Detailed description
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a complex endocrine disorder characterized by reproductive, metabolic, and hormonal abnormalities. Insulin resistance, chronic low-grade inflammation, and hyperandrogenism play central roles in its pathophysiology. Identifying reliable and non-invasive biomarkers may improve early diagnosis, metabolic risk assessment, and long-term clinical follow-up.
Fetuin-A is a glycoprotein involved in insulin signaling and glucose metabolism, whereas resistin is a pro-inflammatory adipokine associated with insulin resistance and metabolic dysfunction. Previous studies evaluating serum concentrations of these biomarkers in women with PMOS have reported inconsistent findings, and little is known about whether salivary concentrations accurately reflect serum levels.
This prospective observational case-control study will enroll 80 women aged 18-35 years, including 40 women diagnosed with PMOS according to the Rotterdam criteria and 40 age-matched healthy controls. Fasting blood and unstimulated saliva samples will be collected simultaneously. Serum and salivary Fetuin-A and resistin concentrations will be measured using enzyme-linked immunosorbent assay (ELISA). Metabolic and hormonal parameters, including fasting glucose, fasting insulin, HbA1c, lipid profile, total testosterone, sex hormone-binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), and the free androgen index (FAI), will also be evaluated.
The primary objective is to determine the correlation between serum and salivary Fetuin-A and resistin levels. Secondary objectives include evaluating associations between these biomarkers and insulin resistance, lipid profile, anthropometric measurements, and hormonal parameters, as well as assessing the potential utility of salivary biomarkers as non-invasive tools for the metabolic evaluation of women with PMOS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMOS Group | – | Diagnostic Test: Blood and Saliva Biomarker AssessmentWomen aged 18 to 35 years diagnosed with Polyendocrine Metabolic Ovarian Syndrome according to the Rotterdam criteria. Participants will undergo clinical and anthropometric evaluation, and fasting serum and unstimulated saliva samples will be collected for Fetuin-A, resistin, metabolic, and hormonal measurements. |
| Healthy Control Group | – | Diagnostic Test: Blood and Saliva Biomarker AssessmentWomen aged 18 to 35 years with regular menstrual cycles and without Polyendocrine Metabolic Ovarian Syndrome. Participants will undergo the same clinical, anthropometric, serum, and saliva assessments as the PMOS group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 18-35 years with Polyendocrine Metabolic Ovarian Syndrome (PMOS) and age-matched healthy women recruited from the outpatient gynecology and endocrinology clinics of Istinye University. Participants will undergo clinical evaluation and fasting blood and unstimulated saliva collection for biochemical analyses.
Key inclusion criteria (11 listed)
- Female, aged 18-35 years
- Diagnosis of Polyendocrine Metabolic Ovarian Syndrome (PMOS) according to the Rotterdam criteria
- BMI <30 kg/m²
- Written informed consent
- Female, aged 18-35 years
Key exclusion criteria (9 listed)
- Pregnancy or breastfeeding
- Diabetes mellitus
- Chronic kidney or liver disease
- Thyroid dysfunction
- Hyperprolactinemia
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 |
|---|---|---|
| Blood and Saliva Biomarker AssessmentParticipants will provide fasting venous blood and unstimulated saliva samples for measurement of Fetuin-A and resistin concentrations using enzyme-linked immunosorbent assay (ELISA). Metabolic and hormonal parameters, including fasting glucose, fasting insulin, HbA1c, lipid profile, total testosterone, sex hormone-binding globulin (SHBG), and dehydroepiandrosterone sulfate (DHEAS), will also be assessed. No therapeutic intervention will be administered. | Diagnostic test | Healthy Control Group, PMOS Group |
Primary outcome
Correlation Between Serum and Salivary Fetuin-A and Resistin Levels
Time frame: At baseline (Day 1)
To determine the correlation between serum and salivary Fetuin-A and resistin concentrations in women with Polyendocrine Metabolic Ovarian Syndrome (PMOS) and healthy controls.
15 secondary outcomes
Serum Fetuin-A Levels
Time frame: Baseline
Salivary Fetuin-A Levels
Time frame: Baseline
Serum Resistin Levels
Time frame: Baseline
Salivary Resistin Levels
Time frame: Baseline
Correlation Between Fetuin-A and Resistin Concentrations and HOMA-IR
Time frame: Baseline
Correlation Between Fetuin-A and Resistin Concentrations and SHBG Concentration
Time frame: Baseline
Correlation of Fetuin-A and Resistin Concentrations With DHEAS Concentration
Time frame: Baseline
Correlation of Fetuin-A and Resistin Concentrations With Free Androgen Index
Time frame: Baseline
Correlation of Fetuin-A and Resistin Concentrations With Total Cholesterol Concentration
Time frame: Baseline
Correlation of Fetuin-A and Resistin Concentrations With LDL Cholesterol Concentration
Time frame: Baseline
Correlation of Fetuin-A and Resistin Concentrations With HDL Cholesterol Concentration
Time frame: Baseline
Correlation of Fetuin-A and Resistin Concentrations With Triglyceride Concentration
Time frame: Baseline
Correlation Between Fetuin-A and Resistin Concentrations and Total Testosterone Concentration
Time frame: Baseline
Correlation Between Fetuin-A and Resistin Concentrations and DHEAS Concentration
Time frame: Baseline
Correlation Between Fetuin-A and Resistin Concentrations and Free Androgen Index
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Polycystic Ovary Syndrome (PCOS) Women, run by Istinye University.
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 11 inclusion and 9 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: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe İrem GÖKÇEK Dr, Dr (5356476880, ayse.gokcek@istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Serum and Salivary Fetuin-A and Resistin Levels (time frame: At baseline (Day 1)). 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 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.