Subclinical Hypothyroidism and Chronic Inflammation in PCOS

Last updated: April 13, 2025
Sponsor: Jagiellonian University
Overall Status: Completed

Phase

N/A

Condition

Inflammation

Thyroid Disorders

Hormone Deficiencies

Treatment

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

Assessment of the impact of imbalance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes on ovarian reserve indices

Measurement and comparison of leucocytosis and concentrations of CRP, procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha in both study arms

Clinical Study ID

NCT05842096
1072.6120.292.2022
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 withsonographically confirmed anovulation with excluded male, tubal and uterineinfertility factors.

Exclusion

Exclusion Criteria:

  • absence of at least one ovary,

  • previously diagnosed thyroid disease

Study Design

Total Participants: 158
Treatment Group(s): 3
Primary Treatment: 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
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 30, 2024

Study 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).

Connect with a study center

  • Jagiellonian University Medical College, Department of Gynecology and Obstetrics

    Krakow, 31-501
    Poland

    Site Not Available

  • Jagiellonian University Medical College, Department of Gynecology and Obstetrics

    Kraków, 31-501
    Poland

    Site Not Available

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