Activity of Chronic Inflammation in PCOS

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D; Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters

• Registration Number: NCT06300593
• Lead Sponsor: Jagiellonian University

Brief Summary

Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.

Detailed Description

The study population will be characterized in terms of demographic (age, BMI), gynaecological (cycle length, menstrual pain, abnormal uterine bleeding) and obstetrics (pregnancies, childbirth, miscarriages) data. PCOS syndrome (and its phenotypes: A, B, C, D) will be recognized by the Rotterdam criteria. During hospitalization, blood samples will be collected for scheduled analyses (20 ml of blood in total).

Study Timeline

• Study Start: 2024-01-15
• Study First Submitted: 2024-03-02
• Study First Submitted QC: 2024-03-02
• Study First Posted: 2024-03-08
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• age 18-45 years
• PCOS syndrome confirmed by the Rotterdam criteria

Exclusion Criteria

• absence of at least one ovary
• diagnosed and/or treated other metabolic disease
• diagnosed and/or treated other endocrine disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCOS phenotype C	Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D	HA + PCOM
PCOS phenotype C	Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters	HA + PCOM
PCOS phenotype A	Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters	clinical and/or biochemical hyperandrogenism (HA) + ovulatory dysfunction (OD) + polycystic ovarian morphology (PCOM)
PCOS phenotype B	Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D	HA + OD
PCOS phenotype A	Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D	clinical and/or biochemical hyperandrogenism (HA) + ovulatory dysfunction (OD) + polycystic ovarian morphology (PCOM)
PCOS phenotype B	Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters	HA + OD
PCOS phenotype D	Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters	OD + PCOM
PCOS phenotype D	Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D	OD + PCOM

Primary Outcome Measures

Name	Time	Method
Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes	up to 3 months	Measurement and comparison of concentrations of IL-1 (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes	up to 3 months	Measurement and comparison of concentrations of IL-10 (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes	up to 3 months	Measurement and comparison of concentrations of TNF-alpha (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes	up to 3 months	Measurement and comparison of leukocyte count (n/µL) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes	up to 3 months	Measurement and comparison of concentrations of IL-6 (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes	up to 3 months	Measurement and comparison of concentrations of CRP (mg/l) in peripheral blood in the four PCOS phenotypes

Secondary Outcome Measures

Name	Time	Method
Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: CRP (mg/l)
Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: TNF-alpha (pg/ml)
Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-1 (pg/ml)
Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between HOMA-IR value and inflammatory parameters: il-6 (pg/ml)
Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between the BMI value and inflammatory parameters: leukocyte count (n/µL)
Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: CRP (mg/l)
Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: CRP (mg/l)
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)
Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: leukocyte count (n/µL)
Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between the BMI value and inflammatory parameters: CRP (mg/l)
Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between BMI value and inflammatory parameters: il-6 (pg/ml)
Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-6 (pg/ml)
Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-10 (pg/ml)
Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-6 (pg/ml)
Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)
Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: CRP (mg/l)
Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between the HOMA-IR and inflammatory parameters: il-1 (pg/ml)
Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between the concentration of HOMA-IR and inflammatory parameters: il-10 (pg/ml)
Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between the BMI and inflammatory parameters: il-1 (pg/ml)
Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between BMI value and inflammatory parameters: il-10 (pg/ml)
Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)
Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)
Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between the BMI value and inflammatory parameters: TNF-alpha (pg/ml)
Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: CRP (mg/l)
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)
Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-1 (pg/ml)
Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-10 (pg/ml)
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)
Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)
Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)
Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: CRP (mg/l)
Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-10 (pg/ml)
Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: CRP (mg/l)
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)
Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-1 (pg/ml)
Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-6 (pg/ml)
Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	up to 3 months	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: TNF-alpha (pg/ml)

Trial Locations

Locations (1)

Jagiellonian University Medical College; 🇵🇱 Krakow, Poland