Jagiellonian University
Krakow, Poland
Location status: Recruiting
NCT Number: NCT06793085
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).
Interested in participating?
Request Info18 year–45 year
Female
Observational
Krakow, Poland
Location status: Recruiting
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women of reproductive age, which, in addition to menstrual disorders and infertility due to anovulation, is characterized by insulin resistance (IR). The metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The severity of IR in women with PCOS is linked to abdominal obesity. There is an urgent need to identify more precise and universal markers of insulin resistance than the HOMA-IR index or glucose tolerance tests, which are intended to identify existing disorders rather than predispositions. Additionally, there is a need to investigate the balance of pro-inflammatory and anti-inflammatory parameters in PCOS and their relationship with insulin resistance, which is responsible for the development of adverse health complications.
The objective of this study is to measure and compare the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, and the 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).
Tests will be conducted using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. The concentrations of the substances under investigation will be measured and compared among the three study groups. Statistical analysis will be performed using SPSS Statistics software.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Measurement of interleukin-18 (il-18) concentration in fasting venous blood serum
Measurement of interleukin-4 (il-4) concentration in fasting venous blood plasma
Time frame: up to 6 months
Measurement and comparison of serum interleukin-6 (il-6) concentration expressed in [pg/ml] in three research groups
Time frame: up to 6 months
Measurement and comparison of serum interleukin-18 (il-18) concentration expressed in [pg/ml] in three research groups
Time frame: up to 6 months
Measurement and comparison of serum interleukin-4 (il-4) concentration expressed in [pg/ml] in three research groups
Time frame: up to 6 months
Measurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in [pg/ml] in three research groups
Contact information is provided by the study sponsor or research team.
Iwona Gawron, Ph.D., M.D.
CONTACT
Robert Jach, Prof., Ph.D., M.D.
CONTACT
Jagiellonian University
Other
Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS
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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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