Pro- and Anti-inflammatory Cytokines in PCOS

Last updated: January 31, 2025
Sponsor: Jagiellonian University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

Measurement of interleukin-4 (il-4) concentration

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

Measurement of interleukin-18 (il-18) concentration

Clinical Study ID

NCT06793085
1072.6120.44.2024-2
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • women aged 18-45 years

Exclusion

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 Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Measurement of interleukin-4 (il-4) concentration
Phase:
Study Start date:
January 20, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Jagiellonian University

    Krakow,
    Poland

    Active - Recruiting

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