Pro- and Anti-inflammatory Cytokines in PCOS
Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS
1 other identifier
observational
100
1 country
1
Brief Summary
The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2025
CompletedStudy Start
First participant enrolled
January 20, 2025
CompletedFirst Posted
Study publicly available on registry
January 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 18, 2026
March 1, 2026
1.4 years
January 20, 2025
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Il-6 concentration
Measurement and comparison of serum interleukin-6 (il-6) concentration expressed in \[pg/ml\] in three research groups
up to 6 months
Il-18 concentration
Measurement and comparison of serum interleukin-18 (il-18) concentration expressed in \[pg/ml\] in three research groups
up to 6 months
Il-4 concentration
Measurement and comparison of serum interleukin-4 (il-4) concentration expressed in \[pg/ml\] in three research groups
up to 6 months
TNF-α concentration
Measurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in \[pg/ml\] in three research groups
up to 6 months
Study Arms (3)
Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)
Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)
No PCOS
Interventions
Measurement of interleukin-18 (il-18) concentration in fasting venous blood serum
Measurement of interleukin-4 (il-4) concentration in fasting venous blood plasma
Measurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum
Measurement of fasting tumor necrosis factor α concentration in fasting venous blood serum
Eligibility Criteria
women aged 18-45 years, managed for menstrual irregularities, infertility or for routine check-up
You may qualify if:
- women aged 18-45 years
You may not qualify if:
- previous removal of at least one ovary
- treated diabetes of any type
- diagnosed and treated metabolic diseases
- diagnosed and treated autoimmune diseases
- diagnosed and treated autoinflammatory diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jagiellonian University
Krakow, Poland
Biospecimen
blood serum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kazimierz Pityński, Prof., Ph.D., M.D.
Jagiellonian University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD, Principal Investigator
Study Record Dates
First Submitted
January 20, 2025
First Posted
January 27, 2025
Study Start
January 20, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 18, 2026
Record last verified: 2026-03