Skip to content

Subclinical Hypothyroidism and Chronic Inflammation in PCOS

The Influence of Subclinical Hypothyroidism on Chronic Inflammation Activity in Women With Different PCOS Phenotypes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05842096
Enrollment
158
Registered
2023-05-03
Start date
2024-01-01
Completion date
2024-12-30
Last updated
2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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).

Interventions

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

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

DIAGNOSTIC_TESTEvaluation 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

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

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

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

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

prospective tertiary single-centre cohort study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Values of inflammation parameters - leukocytosis in peripheral blood in both study armsup to 6 monthsMeasurement 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 armsup to 6 monthsMeasurement and comparison of concentrations of CRP (mg/l) in peripheral blood in both study arms
Values of inflammation parameters - procalcitonine in peripheral blood in both study armsup to 6 monthsMeasurement 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 armsup to 6 monthsMeasurement and comparison of concentrations of procalcitonin fibrinogen (g/l) in peripheral blood in both study arms
Values of inflammation parameters - ferritin in peripheral blood in both study armsup to 6 monthsMeasurement 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 armsup to 6 monthsMeasurement and comparison of concentrations of procalcitonin IL-1 (pg/ml) in peripheral blood in both study arms
Values of inflammation parameters - IL-6 in peripheral blood in both study armsup to 6 monthsMeasurement and comparison of concentrations of procalcitonin IL-6 (pg/ml) in peripheral blood in both study arms
Values of inflammation parameters - IL-10 in peripheral blood in both study armsup to 6 monthsMeasurement 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 armsup to 6 monthsMeasurement and comparison of concentrations of procalcitonin TNF-alpha (pg/ml) in peripheral blood in both study arms

Secondary

MeasureTime frameDescription
Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - leukocytosis in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - CRP in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: CRP (mg/l)
Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - procalcitonin in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: procalcitonin (μg/l)
Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: fibrinogen (μg/l)up to 6 monthsEvaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: fibrinogen (μg/l)
Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: ferritin (μg/l)up to 6 monthsEvaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: ferritin (μg/l)
Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-1 (pg/ml)up to 6 monthsEvaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-1 (pg/ml)
Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-6 (pg/ml)up to 6 monthsEvaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-6 (pg/ml)
Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-10 (pg/ml)up to 6 monthsEvaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-10 (pg/ml)
Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml)up to 6 monthsEvaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: TNF -alpha (pg/ml)
Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - CRP in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: CRP (mg/l)
Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - leukocytosis in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - procalcitonin in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: procalcitonin (μg/l)
Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: fibrinogen (μg/l)up to 6 monthsEvaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: fibrinogen (μg/l)
Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-1 (pg/ml)up to 6 monthsEvaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-1 (pg/ml)
Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-6 (pg/ml)up to 6 monthsEvaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-6 (pg/ml)
Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-10 (pg/ml)up to 6 monthsEvaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-10 (pg/ml)
Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml)up to 6 monthsEvaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml)
Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: ferritin (μg/l)up to 6 monthsEvaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: ferritin (μg/l)
Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - leukocytosis in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - CRP in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: CRP (mg/l)
Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - procalcitonin in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: procalcitonin (μg/l)
Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - fibrinogen in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: fibrinogen (μg/l)
Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - ferritin in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: ferritin (μg/l)
Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-1 in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: il-1 (pg/ml)
Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - leukocytosis in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-10 in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: il-10 (pg/ml)
Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - TNF-alpha in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: TNF-alpha (pg/ml)
Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - leukocytosis in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: leukocyte count (n/µL)
Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - CRP in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: CRP (mg/l)
Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - procalcitonin in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: procalcitonin (μg/l)
Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - fibrinogen in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: fibrinogen (μg/l)
Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - ferritin in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: ferritin (μg/l)
Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-1 in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: il-1 (pg/ml)
Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-6 in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: il-6 (pg/ml)
Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-10 in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: il-10 (pg/ml)
Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - TNF-alpha in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters:TNF-alpha (pg/ml)
Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-6 in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: il-6 (pg/ml)
Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - CRP in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: CRP (mg/l)
Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - procalcitonin in both arms of the studyup to 6 monthsEvaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: procalcitonin (μg/l)
Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: fibrinogen (μg/l)up to 6 monthsEvaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: fibrinogen (g/l)
Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: ferritin (μg/l)up to 6 monthsEvaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: ferritin (μg/l)
Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-1up to 6 monthsEvaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: iL-1 (pg/ml)
Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-6up to 6 monthsEvaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: iL-6 (pg/ml)
Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-10up to 6 monthsEvaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: iL-10 (pg/ml)
Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: TNF-alphaup to 6 monthsEvaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: TNF-alpha (pg/ml)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026