Clinical trial NCT06300593: Activity of Chronic Inflammation in PCOS
Official title: Evaluation of the Activity of Chronic Inflammation and Its Impact on Metabolic and Hormonal Parameters in Various PCOS Phenotypes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS phenotypes
chronic inflammation
metabolic disorders
ovarian reserve
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18-45, treated at the University Hospital in Krakow, diagnosed with PCOS confirmed by the Rotterdam criteria, phenotypes A, B, C, D, without other metabolic and endocrine diseases.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes
timeFrame: up to 3 months
Secondary outcomes:
measure: Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
timeFrame: up to 3 months
measure: Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University Medical College
Study officials:
affiliation: Jagiellonian University
name: Kazimierz Pitynski, Prof.
role: STUDY_CHAIR
References: