Pro- and Anti-inflammatory Cytokines in PCOS

March 17, 2026 updated by: Iwona Magdalena Gawron, Jagiellonian University

Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS

The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women of reproductive age, which, in addition to menstrual disorders and infertility due to anovulation, is characterized by insulin resistance (IR). The metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The severity of IR in women with PCOS is linked to abdominal obesity. There is an urgent need to identify more precise and universal markers of insulin resistance than the HOMA-IR index or glucose tolerance tests, which are intended to identify existing disorders rather than predispositions. Additionally, there is a need to investigate the balance of pro-inflammatory and anti-inflammatory parameters in PCOS and their relationship with insulin resistance, which is responsible for the development of adverse health complications.

The objective of this study is to measure and compare the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, and the anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).

Tests will be conducted using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. The concentrations of the substances under investigation will be measured and compared among the three study groups. Statistical analysis will be performed using SPSS Statistics software.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

women aged 18-45 years, managed for menstrual irregularities, infertility or for routine check-up

Description

Inclusion Criteria:

  • women aged 18-45 years

Exclusion Criteria:

  • previous removal of at least one ovary
  • treated diabetes of any type
  • diagnosed and treated metabolic diseases
  • diagnosed and treated autoimmune diseases
  • diagnosed and treated autoinflammatory diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)
Diagnostic test: Measurement of interleukin-6 (il-6) concentration in blood serum
Measurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum
Diagnostic test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration
Measurement of fasting tumor necrosis factor α concentration in fasting venous blood serum
Diagnostic test: Measurement of interleukin-18 (il-18) concentration
Measurement of interleukin-18 (il-18) concentration in fasting venous blood serum
Diagnostic test: Measurement of interleukin-4 (il-4) concentration
Measurement of interleukin-4 (il-4) concentration in fasting venous blood plasma
Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)
Diagnostic test: Measurement of interleukin-6 (il-6) concentration in blood serum
Measurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum
Diagnostic test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration
Measurement of fasting tumor necrosis factor α concentration in fasting venous blood serum
Diagnostic test: Measurement of interleukin-18 (il-18) concentration
Measurement of interleukin-18 (il-18) concentration in fasting venous blood serum
Diagnostic test: Measurement of interleukin-4 (il-4) concentration
Measurement of interleukin-4 (il-4) concentration in fasting venous blood plasma
No PCOS
Diagnostic test: Measurement of interleukin-6 (il-6) concentration in blood serum
Measurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum
Diagnostic test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration
Measurement of fasting tumor necrosis factor α concentration in fasting venous blood serum
Diagnostic test: Measurement of interleukin-18 (il-18) concentration
Measurement of interleukin-18 (il-18) concentration in fasting venous blood serum
Diagnostic test: Measurement of interleukin-4 (il-4) concentration
Measurement of interleukin-4 (il-4) concentration in fasting venous blood plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Il-6 concentration
Time Frame: up to 6 months
Measurement and comparison of serum interleukin-6 (il-6) concentration expressed in [pg/ml] in three research groups
up to 6 months
Il-18 concentration
Time Frame: up to 6 months
Measurement and comparison of serum interleukin-18 (il-18) concentration expressed in [pg/ml] in three research groups
up to 6 months
Il-4 concentration
Time Frame: up to 6 months
Measurement and comparison of serum interleukin-4 (il-4) concentration expressed in [pg/ml] in three research groups
up to 6 months
TNF-α concentration
Time Frame: up to 6 months
Measurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in [pg/ml] in three research groups
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Study Chair: Kazimierz Pityński, Prof., Ph.D., M.D., Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.44.2024-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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