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NCT Number: NCT06793085

Pro- and Anti-inflammatory Cytokines in 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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of interleukin-6 (il-6) concentration in blood serum

Diagnostic Test

Measurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum

Measurement of fasting tumor necrosis factor α (TNF-α) concentration

Diagnostic Test

Measurement of fasting tumor necrosis factor α concentration in fasting venous blood serum

Measurement of interleukin-18 (il-18) concentration

Diagnostic Test

Measurement of interleukin-18 (il-18) concentration in fasting venous blood serum

Measurement of interleukin-4 (il-4) concentration

Diagnostic Test

Measurement of interleukin-4 (il-4) concentration in fasting venous blood plasma

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Iwona Gawron, Ph.D., M.D.

CONTACT

[email protected]

+48 124248570

Robert Jach, Prof., Ph.D., M.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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