Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842096
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-03-26
Brief Title:
Subclinical Hypothyroidism and Chronic Inflammation in PCOS
Sponsor:
Jagiellonian University
Organization:
Jagiellonian University
Study Overview
Official Title:
The Influence of Subclinical Hypothyroidism on Chronic Inflammation Activity in Women With Different PCOS Phenotypes
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie overproduction of pro-inflammatory factors eg 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 ie 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
Detailed Description:
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 TSH25 uIUml fT3 31-680 pmoll fT4 120-220 pmoll 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
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 TSH25 uIUml fT3 31-680 pmoll fT4 120-220 pmoll 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None