protocolSection identificationModule nctId: NCT06300593, orgStudyIdInfo id: 1072.6120.292.2022-1, briefTitle: Activity of Chronic Inflammation in PCOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Jagiellonian University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Polycystic Ovary Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: 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, interventions name: 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, outcomesModule primaryOutcomes measure: Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes, primaryOutcomes measure: Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes, primaryOutcomes measure: Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes, primaryOutcomes measure: Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes, primaryOutcomes measure: Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes, primaryOutcomes measure: Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jagiellonian University Medical College, status: RECRUITING, city: Krakow, zip: 31-501, country: Poland, contacts name: Iwona Gawron, PhD, MD, role: CONTACT, phone: +48 124248570, email: iwona.gawron@uj.edu.pl, contacts name: Robert Jach, Prof., role: CONTACT, phone: +48 124248571, email: jach@uj-cm.krakow.pl, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False