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AzTrials

PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesNCT05842096

Subclinical Hypothyroidism and Chronic Inflammation in PCOS

A study testing Measurement and comparison of leucocytosis and concentrations of CRP, procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha in both study arms, 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 and Assessment of the impact of imbalance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes on ovarian reserve indices in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and Subclinical hypothyroïdism, run by Jagiellonian University at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Measurement and comparison of leucocytosis and concentrations of CRP, procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha in both study arms, 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 and Assessment of the impact of imbalance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes on ovarian reserve indices
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 sitePoland
Study dates
1 Jan 2024to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Jagiellonian University Medical College, Department of Gynecology and Obstetrics

    Krakow, 31-501

Other trials in Poland

About this study

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

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.

Read the detailed description

The aim of the study is:

  1. 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).

Being tested
Measurement and comparison of leucocytosis and concentrations of CRP, procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha in both study arms, 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
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  • 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 armsDiagnostic 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

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

Study groups in NCT05842096
Study groupRoleWhat they receive
Polycystic ovary syndrome (PCOS)Active comparatorWomen meeting the Rotterdam-ESHRE-ASRM criteria for a diagnosis of PCOS
Receives: 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 comparatorWomen meeting the WHO criteria for a diagnosis of HPOD
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 6 months

  2. 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

    Measured: up to 6 months

  3. 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

    Measured: up to 6 months

  4. 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

    Measured: up to 6 months

  5. 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

    Measured: up to 6 months

  6. 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

    Measured: up to 6 months

  7. 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

    Measured: up to 6 months

  8. 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

    Measured: up to 6 months

  9. 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

    Measured: up to 6 months

Secondary outcomes (45)

  1. Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - leukocytosis in both arms of the study

    Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: leukocyte count (n/µL)

    Measured: up to 6 months

  2. Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - CRP in both arms of the study

    Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: CRP (mg/l)

    Measured: up to 6 months

  3. Correlation between the concentration of TSH (mIU/l) and the parameters of inflammation - procalcitonin in both arms of the study

    Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: procalcitonin (μg/l)

    Measured: up to 6 months

  4. Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: fibrinogen (μg/l)

    Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: fibrinogen (g/l)

    Measured: up to 6 months

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

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

    Measured: up to 6 months

  6. Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-1

    Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: iL-1 (pg/ml)

    Measured: up to 6 months

  7. Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-6

    Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: iL-6 (pg/ml)

    Measured: up to 6 months

  8. Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: il-10

    Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: iL-10 (pg/ml)

    Measured: up to 6 months

  9. Correlation between the concentration of TSH (mIU/l) and inflammatory parameters: TNF-alpha

    Evaluation of the correlation between the concentration of TSH (mIU/l) and inflammatory parameters: TNF-alpha (pg/ml)

    Measured: up to 6 months

  10. Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - leukocytosis in both arms of the study

    Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: leukocyte count (n/µL)

    Measured: up to 6 months

  11. Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - CRP in both arms of the study

    Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: CRP (mg/l)

    Measured: up to 6 months

  12. Correlation between the concentration of a-TPO (IU/ml) and the parameters of inflammation - procalcitonin in both arms of the study

    Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: procalcitonin (μg/l)

    Measured: up to 6 months

  13. Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: fibrinogen (μg/l)

    Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: fibrinogen (μg/l)

    Measured: up to 6 months

  14. Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: ferritin (μg/l)

    Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: ferritin (μg/l)

    Measured: up to 6 months

  15. Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-1 (pg/ml)

    Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-1 (pg/ml)

    Measured: up to 6 months

  16. Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-6 (pg/ml)

    Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-6 (pg/ml)

    Measured: up to 6 months

  17. Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-10 (pg/ml)

    Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: il-10 (pg/ml)

    Measured: up to 6 months

  18. Correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml)

    Evaluation of the correlation between the concentration of a-TPO (IU/ml) and inflammatory parameters: TNF -alpha (pg/ml)

    Measured: up to 6 months

  19. Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - CRP in both arms of the study

    Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: CRP (mg/l)

    Measured: up to 6 months

  20. Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - leukocytosis in both arms of the study

    Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: leukocyte count (n/µL)

    Measured: up to 6 months

  21. Correlation between the concentration of a-TG (IU/ml) and the parameters of inflammation - procalcitonin in both arms of the study

    Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: procalcitonin (μg/l)

    Measured: up to 6 months

  22. Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: fibrinogen (μg/l)

    Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: fibrinogen (μg/l)

    Measured: up to 6 months

  23. Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-1 (pg/ml)

    Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-1 (pg/ml)

    Measured: up to 6 months

  24. Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-6 (pg/ml)

    Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-6 (pg/ml)

    Measured: up to 6 months

  25. Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-10 (pg/ml)

    Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: il-10 (pg/ml)

    Measured: up to 6 months

  26. Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml)

    Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: TNF-alpha (pg/ml)

    Measured: up to 6 months

  27. Correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: ferritin (μg/l)

    Evaluation of the correlation between the concentration of a-TG (IU/ml) and inflammatory parameters: ferritin (μg/l)

    Measured: up to 6 months

  28. Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - leukocytosis in both arms of the study

    Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: leukocyte count (n/µL)

    Measured: up to 6 months

  29. Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - CRP in both arms of the study

    Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: CRP (mg/l)

    Measured: up to 6 months

  30. Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - procalcitonin in both arms of the study

    Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: procalcitonin (μg/l)

    Measured: up to 6 months

  31. Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - fibrinogen in both arms of the study

    Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: fibrinogen (μg/l)

    Measured: up to 6 months

  32. Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - ferritin in both arms of the study

    Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: ferritin (μg/l)

    Measured: up to 6 months

  33. Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-1 in both arms of the study

    Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: il-1 (pg/ml)

    Measured: up to 6 months

  34. Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-6 in both arms of the study

    Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: il-6 (pg/ml)

    Measured: up to 6 months

  35. Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - il-10 in both arms of the study

    Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: il-10 (pg/ml)

    Measured: up to 6 months

  36. Correlation between the concentration of AMH (pmol/l) and the parameters of inflammation - TNF-alpha in both arms of the study

    Evaluation of the correlation between the concentration of AMH (pmol/l) and inflammatory parameters: TNF-alpha (pg/ml)

    Measured: up to 6 months

  37. Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - leukocytosis in both arms of the study

    Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: leukocyte count (n/µL)

    Measured: up to 6 months

  38. Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - CRP in both arms of the study

    Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: CRP (mg/l)

    Measured: up to 6 months

  39. Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - procalcitonin in both arms of the study

    Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: procalcitonin (μg/l)

    Measured: up to 6 months

  40. Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - fibrinogen in both arms of the study

    Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: fibrinogen (μg/l)

    Measured: up to 6 months

  41. Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - ferritin in both arms of the study

    Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: ferritin (μg/l)

    Measured: up to 6 months

  42. Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-1 in both arms of the study

    Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: il-1 (pg/ml)

    Measured: up to 6 months

  43. Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-6 in both arms of the study

    Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: il-6 (pg/ml)

    Measured: up to 6 months

  44. Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - il-10 in both arms of the study

    Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters: il-10 (pg/ml)

    Measured: up to 6 months

  45. Correlation between the concentration of FSH (IU/l) and the parameters of inflammation - TNF-alpha in both arms of the study

    Evaluation of the correlation between the concentration of FSH (IU/l) and inflammatory parameters:TNF-alpha (pg/ml)

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start1 Jan 2024
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
prospective tertiary single-centre cohort study
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05842096
Sponsor's protocol ID
1072.6120.292.2022
Status last verified
Apr 2025
First submitted
26 Mar 2023
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Measurement and comparison of leucocytosis and concentrations of CRP, procalcitonin, fibrinogen, ferritin, IL-1, IL-6, IL-10, TNF-alpha in both study arms, 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 and Assessment of the impact of imbalance between anti- and pro-inflammatory factors in women with different PCOS and HPOD phenotypes on ovarian reserve indices in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and Subclinical hypothyroïdism, run by Jagiellonian University at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Values of inflammation parameters - leukocytosis in peripheral blood in both study arms (time frame: up to 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05842096.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.

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