Pro- and Anti-inflammatory Cytokines in PCOS

Jagiellonian University

Status: Enrolling

Conditions: Reproductive Age; PCOS (Polycystic Ovary Syndrome)

Treatments: 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-4 (il-4) concentration; Diagnostic Test: Measurement of interleukin-18 (il-18) concentration

Study type: Observational

Funder types: Other

Identifiers

NCT06793085

1072.6120.44.2024-2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)

Treatment:

Diagnostic Test: Measurement of interleukin-18 (il-18) concentration

Diagnostic Test: Measurement of interleukin-4 (il-4) concentration

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

Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum

Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)

Treatment:

Diagnostic Test: Measurement of interleukin-18 (il-18) concentration

Diagnostic Test: Measurement of interleukin-4 (il-4) concentration

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

Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum

No PCOS

Treatment:

Diagnostic Test: Measurement of interleukin-18 (il-18) concentration

Diagnostic Test: Measurement of interleukin-4 (il-4) concentration

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

Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum