Pro- and Anti-inflammatory Cytokines in PCOS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Measurement of interleukin-6 (il-6) concentration in blood serum, Measurement of fasting tumor necrosis factor α (TNF-α) concentration, Measurement of interleukin-18 (il-18) concentration, Measurement of interleukin-4 (il-4) concentration.
- Who it may be relevant to
- Registry conditions: Reproductive Age, PCOS (Polycystic Ovary Syndrome). Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS
Overview
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 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
Primary outcome measures
- Il-6 concentration [Time frame: up to 6 months]
- Il-18 concentration [Time frame: up to 6 months]
- Il-4 concentration [Time frame: up to 6 months]
- TNF-α concentration [Time frame: up to 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Jagiellonian University — Krakow
Identifiers
NCT: NCT06793085 · 1072.6120.44.2024-2