NCT06300593

Activity of Chronic Inflammation in PCOS

Evaluation of the Activity of Chronic Inflammation and Its Impact on Metabolic and Hormonal Parameters in Various PCOS Phenotypes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: —

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).

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
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	A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to determine and compare the above parameters of peripheral blood in the four study arms
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	A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to test the above correlations in the four study arms

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2024-03-08
• Last updated: 2024-07-30

Locations

1 site across 1 country: Poland