An observational study in Polycystic Ovary Syndrome, Polycystic Ovary Syndrome (PCOS) Women and Fetuin-A, sponsored by Istinye University. Not yet recruiting. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Istinye University · Observational
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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.
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.
958 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 80 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Istinye University is the lead sponsor of 221 studies on the registry; 93 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
PMOS Group:
Healthy Control Group:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Blood and Saliva Biomarker Assessment
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.
Diagnostic Test: Blood and Saliva Biomarker Assessment
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.
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.
Time frame: At baseline (Day 1)
Serum Fetuin-A Levels
Comparison of serum Fetuin-A concentrations between women with PMOS and healthy controls.
Time frame: Baseline
Salivary Fetuin-A Levels
Comparison of salivary Fetuin-A concentrations between women with PMOS and healthy controls
Time frame: Baseline
Serum Resistin Levels
Comparison of serum resistin concentrations between women with PMOS and healthy controls.
Time frame: Baseline
Salivary Resistin Levels
Comparison of salivary resistin concentrations between women with PMOS and healthy controls.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 71 non-industry observational studies under Polycystic Ovary Syndrome, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 47. This study's planned 5 months is below that.
Counting every sponsor, half of 74 studies reached it within 14 months; a quarter within 6 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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