NCT06793085

Pro- and Anti-inflammatory Cytokines in PCOS

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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).

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.

Conditions

• Reproductive Age
• PCOS (Polycystic Ovary Syndrome)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2025-01-27
• Last updated: 2026-03-18

Locations

1 site across 1 country: Poland