PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Clinical Trial
Official title:
The Influence of Subclinical Hypothyroidism on Chronic Inflammation Activity in Women With Different PCOS Phenotypes
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. Concomitant endocrinopathies, i.e. obesity, dyslipidemia, insulin resistance, diabetes and thyroid diseases, may additionally influence the activity of chronic inflammation. There is no data indicating the relationship between chronic inflammation and PCOS phenotypes, the severity of metabolic disorders, ovarian reserve and the influence of thyroid function on its activity in PCOS.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | April 30, 2024 |
| Est. primary completion date | April 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility | Inclusion Criteria: - age 18-45 years, - cycle length <21 days or > 35 days, - unsuccessful attempts to conceive for at least 12 months of regular intercourse with sonographically confirmed anovulation with excluded male, tubal and uterine infertility factors. Exclusion Criteria: - absence of at least one ovary, - previously diagnosed thyroid disease |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Jagiellonian University Medical College, Department of Gynecology and Obstetrics | Krakow | |
| Poland | Jagiellonian University Medical College, Department of Gynecology and Obstetrics | Kraków |
| Lead Sponsor | Collaborator |
|---|---|
| Jagiellonian University |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Values of inflammation parameters - leukocytosis in peripheral blood in both study arms | Measurement and comparison of leukocyte count (n/µL) in peripheral blood in both study arms | up to 6 months | |
| Primary | Values of inflammation parameters - CRP in peripheral blood in both study arms | Measurement and comparison of concentrations of CRP (mg/l) in peripheral blood in both study arms | up to 6 months | |
| Primary | Values of inflammation parameters - procalcitonine in peripheral blood in both study arms | Measurement and comparison of concentrations of procalcitonin (µg/l) in peripheral blood in both study arms | up to 6 months | |
| Primary | Values of inflammation parameters - fibrinogen in peripheral blood in both study arms | Measurement and comparison of concentrations of procalcitonin fibrinogen (g/l) in peripheral blood in both study arms | up to 6 months | |
| Primary | Values of inflammation parameters - ferritin in peripheral blood in both study arms | Measurement and comparison of concentrations of procalcitonin ferritin (µg/l) in peripheral blood in both study arms | up to 6 months | |
| Primary | Values of inflammation parameters - IL-1 in peripheral blood in both study arms | Measurement and comparison of concentrations of procalcitonin IL-1 (pg/ml) in peripheral blood in both study arms | up to 6 months | |
| Primary | Values of inflammation parameters - IL-6 in peripheral blood in both study arms | Measurement and comparison of concentrations of procalcitonin IL-6 (pg/ml) in peripheral blood in both study arms | up to 6 months | |
| Primary | Values of inflammation parameters - IL-10 in peripheral blood in both study arms | Measurement and comparison of concentrations of procalcitonin IL-10 (pg/ml) in peripheral blood in both study arms | up to 6 months | |
| Primary | Values of inflammation parameters - TNF-alpha in peripheral blood in both study arms | Measurement and comparison of concentrations of procalcitonin TNF-alpha (pg/ml) in peripheral blood in both study arms | up to 6 months | |
| Secondary | Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - leukocytosis in both arms of the study | Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: leukocyte count (n/µL) | up to 6 months | |
| Secondary | Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - CRP in both arms of the study | Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: CRP (mg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - procalcitonin in both arms of the study | Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: procalcitonin (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: fibrinogen (µg/l) | Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: fibrinogen (g/l) | up to 6 months | |
| Secondary | Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: ferritin (µg/l) | Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: ferritin (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-1 | Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: iL-1 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-6 | Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: iL-6 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-10 | Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: iL-10 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: TNF-alpha | Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: TNF-alpha (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - leukocytosis in both arms of the study | Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: leukocyte count (n/µL) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - CRP in both arms of the study | Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: CRP (mg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - procalcitonin in both arms of the study | Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: procalcitonin (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: fibrinogen (µg/l) | Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: fibrinogen (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: ferritin (µg/l) | Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: ferritin (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-1 (pg/ml) | Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-1 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-6 (pg/ml) | Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-6 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-10 (pg/ml) | Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-10 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml) | Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: TNF -alpha (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - CRP in both arms of the study | Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: CRP (mg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - leukocytosis in both arms of the study | Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: leukocyte count (n/µL) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - procalcitonin in both arms of the study | Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: procalcitonin (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: fibrinogen (µg/l) | Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: fibrinogen (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-1 (pg/ml) | Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-1 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-6 (pg/ml) | Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-6 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-10 (pg/ml) | Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-10 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml) | Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: ferritin (µg/l) | Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: ferritin (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - leukocytosis in both arms of the study | Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: leukocyte count (n/µL) | up to 6 months | |
| Secondary | Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - CRP in both arms of the study | Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: CRP (mg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - procalcitonin in both arms of the study | Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: procalcitonin (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - fibrinogen in both arms of the study | Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: fibrinogen (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - ferritin in both arms of the study | Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: ferritin (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-1 in both arms of the study | Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: il-1 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-6 in both arms of the study | Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: il-6 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-10 in both arms of the study | Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: il-10 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - TNF-alpha in both arms of the study | Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: TNF-alpha (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - leukocytosis in both arms of the study | Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: leukocyte count (n/µL) | up to 6 months | |
| Secondary | Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - CRP in both arms of the study | Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: CRP (mg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - procalcitonin in both arms of the study | Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: procalcitonin (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - fibrinogen in both arms of the study | Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: fibrinogen (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - ferritin in both arms of the study | Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: ferritin (µg/l) | up to 6 months | |
| Secondary | Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-1 in both arms of the study | Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: il-1 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-6 in both arms of the study | Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: il-6 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-10 in both arms of the study | Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: il-10 (pg/ml) | up to 6 months | |
| Secondary | Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - TNF-alpha in both arms of the study | Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters:TNF-alpha (pg/ml) | up to 6 months |