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Completed

NCT Number: NCT06300593

Activity of Chronic Inflammation in PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Jagiellonian University Medical College

Krakow, 31-501, Poland

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

Diagnostic Test

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

Primary outcomes

  1. Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes

    Time frame: up to 3 months

    Measurement and comparison of leukocyte count (n/µL) in peripheral blood in the four PCOS phenotypes

  2. Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes

    Time frame: up to 3 months

    Measurement and comparison of concentrations of CRP (mg/l) in peripheral blood in the four PCOS phenotypes

  3. Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes

    Time frame: up to 3 months

    Measurement and comparison of concentrations of IL-1 (pg/ml) in peripheral blood in the four PCOS phenotypes

  4. Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes

    Time frame: up to 3 months

    Measurement and comparison of concentrations of IL-6 (pg/ml) in peripheral blood in the four PCOS phenotypes

  5. Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes

    Time frame: up to 3 months

    Measurement and comparison of concentrations of IL-10 (pg/ml) in peripheral blood in the four PCOS phenotypes

  6. Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes

    Time frame: up to 3 months

    Measurement and comparison of concentrations of TNF-alpha (pg/ml) in peripheral blood in the four PCOS phenotypes

Secondary outcomes

  1. Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: leukocyte count (n/µL)

  2. Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: CRP (mg/l)

  3. Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between the HOMA-IR and inflammatory parameters: il-1 (pg/ml)

  4. Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between HOMA-IR value and inflammatory parameters: il-6 (pg/ml)

  5. Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between the concentration of HOMA-IR and inflammatory parameters: il-10 (pg/ml)

  6. Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: TNF-alpha (pg/ml)

  7. Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between the BMI value and inflammatory parameters: leukocyte count (n/µL)

  8. Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between the BMI value and inflammatory parameters: CRP (mg/l)

  9. Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between the BMI and inflammatory parameters: il-1 (pg/ml)

  10. Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between BMI value and inflammatory parameters: il-6 (pg/ml)

  11. Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between BMI value and inflammatory parameters: il-10 (pg/ml)

  12. Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between the BMI value and inflammatory parameters: TNF-alpha (pg/ml)

  13. Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)

  14. Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: CRP (mg/l)

  15. Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-1 (pg/ml)

  16. Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-6 (pg/ml)

  17. Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-10 (pg/ml)

  18. Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)

  19. Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)

  20. Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: CRP (mg/l)

  21. Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-1 (pg/ml)

  22. Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-6 (pg/ml)

  23. Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-10 (pg/ml)

  24. Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)

  25. Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)

  26. Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: CRP (mg/l)

  27. Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)

  28. Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)

  29. Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)

  30. Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)

  31. Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)

  32. Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: CRP (mg/l)

  33. Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)

  34. Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)

  35. Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)

  36. Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)

  37. Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)

  38. Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: CRP (mg/l)

  39. Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)

  40. Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)

  41. Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)

  42. Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)

  43. Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: leukocyte count (n/µL)

  44. Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: CRP (mg/l)

  45. Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-1 (pg/ml)

  46. Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-6 (pg/ml)

  47. Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-10 (pg/ml)

  48. Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes

    Time frame: up to 3 months

    Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: TNF-alpha (pg/ml)

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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