Subclinical Hypothyroidism and Chronic Inflammation in PCOS

NCT05842096 | Completed DMC

• 1 other identifier: 1072.6120.292.2022
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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), 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.

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Subclinical hypothyroïdism; Hypothalamic-Pituitary-Gonadal Axis Dysfunction

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (45)

• 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 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: fibrinogen (μg/l)

  up to 6 months

• Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: ferritin (μg/l)

  up to 6 months

Study Arms (2)

Polycystic ovary syndrome (PCOS)

ACTIVE COMPARATOR

Women meeting the Rotterdam-ESHRE-ASRM criteria for a diagnosis of PCOS

Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of CRP, procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha in both study arms; Diagnostic Test: 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; Diagnostic Test: Assessment of the impact of imbalance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes on ovarian reserve indices

Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD)

ACTIVE COMPARATOR

Women meeting the WHO criteria for a diagnosis of HPOD

Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of CRP, procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha in both study arms; Diagnostic Test: 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; Diagnostic Test: Assessment of the impact of imbalance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes on ovarian reserve indices

Interventions

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

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

Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD); Polycystic ovary syndrome (PCOS)

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 DIAGNOSTIC_TEST

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

Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD); Polycystic ovary syndrome (PCOS)

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

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

Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD); Polycystic ovary syndrome (PCOS)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• absence of at least one ovary,
• previously diagnosed thyroid disease

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, 31-501, Poland

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Robert Jach, Prof., Ph.D.

  Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Principal Investigator

Model Details: prospective tertiary single-centre cohort study

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: May 3, 2023
• Study Start: January 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)