Pro- and Anti-inflammatory Cytokines in PCOS

NCT ID: NCT06793085

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Reproductive Age PCOS (Polycystic Ovary Syndrome)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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

Measurement of interleukin-18 (il-18) concentration

Intervention Type DIAGNOSTIC_TEST

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

Measurement of interleukin-4 (il-4) concentration

Intervention Type DIAGNOSTIC_TEST

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

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

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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

Measurement of interleukin-18 (il-18) concentration

Intervention Type DIAGNOSTIC_TEST

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

Measurement of interleukin-4 (il-4) concentration

Intervention Type DIAGNOSTIC_TEST

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

No PCOS

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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

Measurement of interleukin-18 (il-18) concentration

Intervention Type DIAGNOSTIC_TEST

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

Measurement of interleukin-4 (il-4) concentration

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Measurement of interleukin-18 (il-18) concentration

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

Intervention Type DIAGNOSTIC_TEST

Measurement of interleukin-4 (il-4) concentration

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Iwona Magdalena Gawron

PhD, MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kazimierz Pityński, Prof., Ph.D., M.D.

Role: STUDY_CHAIR

Jagiellonian University

Locations

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Jagiellonian University

Krakow, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Iwona Gawron, Ph.D., M.D.

Role: CONTACT

+48 124248570

Robert Jach, Prof., Ph.D., M.D.

Role: CONTACT

Facility Contacts

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Iwona Gawron, Ph.D., M.D.

Role: primary

Other Identifiers

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1072.6120.44.2024-2

Identifier Type: -

Identifier Source: org_study_id

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