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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06793085
Enrollment
100
Registered
2025-01-27
Start date
2025-01-20
Completion date
2026-12-31
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS (Polycystic Ovary Syndrome), Reproductive Age

Keywords

menstrual disorders, chronic inflammation, insulin resistance, metabolic syndrome, Polycystic Ovary Syndrome

Brief 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.

Interventions

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

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

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

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

DIAGNOSTIC_TESTMeasurement of interleukin-18 (il-18) concentration

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

DIAGNOSTIC_TESTMeasurement of interleukin-4 (il-4) concentration

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

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Il-6 concentrationup to 6 monthsMeasurement and comparison of serum interleukin-6 (il-6) concentration expressed in \[pg/ml\] in three research groups
Il-18 concentrationup to 6 monthsMeasurement and comparison of serum interleukin-18 (il-18) concentration expressed in \[pg/ml\] in three research groups
Il-4 concentrationup to 6 monthsMeasurement and comparison of serum interleukin-4 (il-4) concentration expressed in \[pg/ml\] in three research groups
TNF-α concentrationup to 6 monthsMeasurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in \[pg/ml\] in three research groups

Countries

Poland

Contacts

CONTACTIwona Gawron, Ph.D., M.D.
iwona.gawron@uj.edu.pl+48 124248570
CONTACTRobert Jach, Prof., Ph.D., M.D.
jach@cm-uj.krakow.pl
STUDY_CHAIRKazimierz Pityński, Prof., Ph.D., M.D.

Jagiellonian University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026