Trial Title:
Subclinical Hypothyroidism and Chronic Inflammation in PCOS
NCT ID:
NCT05842096
Condition:
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Subclinical hypothyroïdism
Hypothalamic-Pituitary-Gonadal Axis Dysfunction
Conditions: Official terms:
Polycystic Ovary Syndrome
Hypothyroidism
Inflammation
Antibodies
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
prospective tertiary single-centre cohort study
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Measurement and comparison of leucocytosis and concentrations of CRP, procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha in both study arms
Description:
A venous blood sample of approximately 10 ml will be collected in the morning after 8
hours of fasting to determine and compare the above parameters of peripheral blood in
both arms of the study
Arm group label:
Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD)
Arm group label:
Polycystic ovary syndrome (PCOS)
Intervention type:
Diagnostic Test
Intervention name:
Evaluation of the impact of subclinical hypothyroidism, with present/ absent antithyroid antibodies, on the balance between anti- and pro-inflammatory factors in women in both study arms
Description:
A venous blood sample of approximately 10 ml will be collected in the morning after 8
hours of fasting to determine and compare blood levels of leukocytosis, CRP,
procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha depending on the blood
concentrations of TSH, a-TPO and a-TG in women in both study arms
Arm group label:
Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD)
Arm group label:
Polycystic ovary syndrome (PCOS)
Intervention type:
Diagnostic Test
Intervention name:
Assessment of the impact of imbalance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes on ovarian reserve indices
Description:
A venous blood sample of approximately 10 ml will be collected in the morning after 8
hours of fasting to determine and compare blood levels of leukocytosis, CRP,
procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha and AMH, FSH in women
in both study arms
Arm group label:
Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD)
Arm group label:
Polycystic ovary syndrome (PCOS)
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), 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.
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
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).
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Address:
City:
Krakow
Zip:
31-501
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Iwona Gawron, Ph.D.
Phone:
+48 124248570
Email:
iwona.gawron@uj.edu.pl
Contact backup:
Last name:
Jach Robert, Prof., Ph.D.
Phone:
+48124248571
Email:
jach@cm-uj.krakow.pl
Facility:
Name:
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Address:
City:
Kraków
Zip:
31-501
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Iwona M. Gawron, Ph.D.
Phone:
+48 12 4248570
Email:
iwona.gawron@uj.edu.pl
Contact backup:
Last name:
Robert Jach, Prof.
Phone:
+48 12 4248571
Email:
robert.jach@uj.edu.pl
Investigator:
Last name:
Iwona M. Gawron, Ph.D.
Email:
Principal Investigator
Investigator:
Last name:
Krzysztof Skotniczny, Ph.D.
Email:
Sub-Investigator
Start date:
January 1, 2024
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Jagiellonian University
Agency class:
Other
Source:
Jagiellonian University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05842096
