Pro- and Anti-inflammatory Cytokines in PCOS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorJagiellonian University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
women aged 18-45 years
Disqualifiers
previous removal of at least one ovary
treated diabetes of any type
diagnosed and treated metabolic diseases
diagnosed and treated autoimmune diseases
Trial population
women aged 18-45 years, managed for menstrual irregularities, infertility or for routine check-up
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Measurement of interleukin-6 (il-6) concentration in blood serum
Diagnostic testMeasurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum
Measurement of fasting tumor necrosis factor α (TNF-α) concentration
Diagnostic testMeasurement of fasting tumor necrosis factor α concentration in fasting venous blood serum
Measurement of interleukin-18 (il-18) concentration
Diagnostic testMeasurement of interleukin-18 (il-18) concentration in fasting venous blood serum
Measurement of interleukin-4 (il-4) concentration
Diagnostic testMeasurement of interleukin-4 (il-4) concentration in fasting venous blood plasma
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)4 interventions
Group B: Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)4 interventions
Group C: No PCOS4 interventions
Trial outcomes
Primary outcomes
1
Il-6 concentration
Measurement and comparison of serum interleukin-6 (il-6) concentration expressed in \[pg/ml\] in three research groups
Time frame
up to 6 months2
Il-18 concentration
Measurement and comparison of serum interleukin-18 (il-18) concentration expressed in \[pg/ml\] in three research groups
Time frame
up to 6 months3
Il-4 concentration
Measurement and comparison of serum interleukin-4 (il-4) concentration expressed in \[pg/ml\] in three research groups
Time frame
up to 6 months4
TNF-α concentration
Measurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in \[pg/ml\] in three research groups
Time frame
up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov