The Influence of Subclinical Hypothyroidism on Chronic Inflammation Activity in Women With Different PCOS Phenotypes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Values of inflammation parameters - procalcitonine in peripheral blood in both study arms
研究概览
简要总结
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.
详细描述
The aim of the study is:
i) to assess and compare serum concentrations of selected inflammatory markers (leucocytosis, CRP, procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha) in women with different phenotypes PCOS and hypothalamic-pituitary-ovarian axis dysfunction (HPOD) (control), ii) to evaluate the impact of subclinical hypothyroidism (defined as TSH>2.5 uIU/ml, fT3 3,1-6,80 pmol/l, fT4 12,0-22,0 pmol/l), with the presence and absence of circulating antithyroid antibodies (a-TPO and a-TG), on the balance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes, iii) to assess the impact of imbalance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes on ovarian reserve indices, expressed as FSH and AMH concentrations.
The study population will be characterized in terms of demographic (age, BMI), gynecological (age of first and last menstrual period, cycle length, history of reproductive organ surgeries, ultrasound measurements of endometrial width, ovarian volume) and obstetrics (pregnancies, childbirth, miscarriages) data. PCOS syndrome (and its phenotypes) will be recognized by the Rotterdam criteria. HPOD will be diagnosed according to WHO criteria. During hospitalization, blood samples will be collected for scheduled analyzes (30 ml of blood in total).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •absence of at least one ovary,
- •previously diagnosed thyroid disease
结局指标
主要结局
Values of inflammation parameters - procalcitonine in peripheral blood in both study arms
时间窗: up to 6 months
Measurement and comparison of concentrations of procalcitonin (μg/l) in peripheral blood in both study arms
Values of inflammation parameters - fibrinogen in peripheral blood in both study arms
时间窗: up to 6 months
Measurement and comparison of concentrations of procalcitonin fibrinogen (g/l) in peripheral blood in both study arms
Values of inflammation parameters - IL-6 in peripheral blood in both study arms
时间窗: up to 6 months
Measurement and comparison of concentrations of procalcitonin IL-6 (pg/ml) in peripheral blood in both study arms
Values of inflammation parameters - leukocytosis in peripheral blood in both study arms
时间窗: up to 6 months
Measurement and comparison of leukocyte count (n/µL) in peripheral blood in both study arms
Values of inflammation parameters - CRP in peripheral blood in both study arms
时间窗: up to 6 months
Measurement and comparison of concentrations of CRP (mg/l) in peripheral blood in both study arms
Values of inflammation parameters - ferritin in peripheral blood in both study arms
时间窗: up to 6 months
Measurement and comparison of concentrations of procalcitonin ferritin (μg/l) in peripheral blood in both study arms
Values of inflammation parameters - IL-1 in peripheral blood in both study arms
时间窗: up to 6 months
Measurement and comparison of concentrations of procalcitonin IL-1 (pg/ml) in peripheral blood in both study arms
Values of inflammation parameters - IL-10 in peripheral blood in both study arms
时间窗: up to 6 months
Measurement and comparison of concentrations of procalcitonin IL-10 (pg/ml) in peripheral blood in both study arms
Values of inflammation parameters - TNF-alpha in peripheral blood in both study arms
时间窗: up to 6 months
Measurement and comparison of concentrations of procalcitonin TNF-alpha (pg/ml) in peripheral blood in both study arms
次要结局
- Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - procalcitonin in both arms of the study(up to 6 months)
- Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: ferritin (μg/l)(up to 6 months)
- Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - CRP in both arms of the study(up to 6 months)
- Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - procalcitonin in both arms of the study(up to 6 months)
- Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-1 (pg/ml)(up to 6 months)
- Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-6(up to 6 months)
- Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: fibrinogen (μg/l)(up to 6 months)
- Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-10 (pg/ml)(up to 6 months)
- Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-1 in both arms of the study(up to 6 months)
- Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - TNF-alpha in both arms of the study(up to 6 months)
- Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-1 in both arms of the study(up to 6 months)
- Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - leukocytosis in both arms of the study(up to 6 months)
- Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: fibrinogen (μg/l)(up to 6 months)
- Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-1(up to 6 months)
- Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-10(up to 6 months)
- Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - leukocytosis in both arms of the study(up to 6 months)
- Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: fibrinogen (μg/l)(up to 6 months)
- Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-1 (pg/ml)(up to 6 months)
- Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-6 (pg/ml)(up to 6 months)
- Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml)(up to 6 months)
- Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - procalcitonin in both arms of the study(up to 6 months)
- Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - leukocytosis in both arms of the study(up to 6 months)
- Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - fibrinogen in both arms of the study(up to 6 months)
- Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-6 in both arms of the study(up to 6 months)
- Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - leukocytosis in both arms of the study(up to 6 months)
- Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - CRP in both arms of the study(up to 6 months)
- Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: TNF-alpha(up to 6 months)
- Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: ferritin (μg/l)(up to 6 months)
- Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - CRP in both arms of the study(up to 6 months)
- Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - leukocytosis in both arms of the study(up to 6 months)
- Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-10 (pg/ml)(up to 6 months)
- Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - procalcitonin in both arms of the study(up to 6 months)
- Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - ferritin in both arms of the study(up to 6 months)
- Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-10 in both arms of the study(up to 6 months)
- Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - TNF-alpha in both arms of the study(up to 6 months)
- Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-6 (pg/ml)(up to 6 months)
- Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - fibrinogen in both arms of the study(up to 6 months)
- Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - ferritin in both arms of the study(up to 6 months)
- Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml)(up to 6 months)
- Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: ferritin (μg/l)(up to 6 months)
- Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - CRP in both arms of the study(up to 6 months)
- Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-10 in both arms of the study(up to 6 months)
- Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - CRP in both arms of the study(up to 6 months)
- Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - procalcitonin in both arms of the study(up to 6 months)
- Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-6 in both arms of the study(up to 6 months)
研究者
Iwona Magdalena Gawron
Ph.D., Principal Investigator
Jagiellonian University