Clinical trial NCT06793085: Pro- and Anti-inflammatory Cytokines in PCOS
Official title: Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Reproductive Age
PCOS (Polycystic Ovary Syndrome)
Keywords: menstrual disorders
chronic inflammation
insulin resistance
metabolic syndrome
Polycystic Ovary Syndrome
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women aged 18-45 years, managed for menstrual irregularities, infertility or for routine check-up

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.

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

Primary outcomes:
measure: Il-6 concentration
timeFrame: up to 6 months
measure: Il-18 concentration
timeFrame: up to 6 months
measure: Il-4 concentration
timeFrame: up to 6 months
measure: TNF-α concentration
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University
Study officials:
affiliation: Jagiellonian University
name: Kazimierz Pityński, Prof., Ph.D., M.D.
role: STUDY_CHAIR
References: