An observational study in Reproductive Age and PCOS (Polycystic Ovary Syndrome), sponsored by Jagiellonian University. Recruiting at 1 site in Poland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Jagiellonian University · Observational
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).
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's planned enrollment of 100 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.
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women aged 18-45 years, managed for menstrual irregularities, infertility or for routine check-up
Exclusion Criteria:
Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum · Diagnostic Test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration · Diagnostic Test: Measurement of interleukin-18 (il-18) concentration · Diagnostic Test: Measurement of interleukin-4 (il-4) concentration
Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum · Diagnostic Test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration · Diagnostic Test: Measurement of interleukin-18 (il-18) concentration · Diagnostic Test: Measurement of interleukin-4 (il-4) concentration
Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum · Diagnostic Test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration · Diagnostic Test: Measurement of interleukin-18 (il-18) concentration · Diagnostic Test: Measurement of interleukin-4 (il-4) concentration
Measurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum
Measurement of fasting tumor necrosis factor α concentration in fasting venous blood serum
Measurement of interleukin-18 (il-18) concentration in fasting venous blood serum
Measurement of interleukin-4 (il-4) concentration in fasting venous blood plasma
Il-6 concentration
Measurement and comparison of serum interleukin-6 (il-6) concentration expressed in \[pg/ml\] in three research groups
Time frame: up to 6 months
Il-18 concentration
Measurement and comparison of serum interleukin-18 (il-18) concentration expressed in \[pg/ml\] in three research groups
Time frame: up to 6 months
Il-4 concentration
Measurement and comparison of serum interleukin-4 (il-4) concentration expressed in \[pg/ml\] in three research groups
Time frame: up to 6 months
TNF-α concentration
Measurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in \[pg/ml\] in three research groups
Time frame: up to 6 months
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Jagiellonian University