Polycystic Ovary SyndromeNCT06300593
Activity of Chronic Inflammation in PCOS
An observational study of Polycystic Ovary Syndrome, run by Jagiellonian University at 1 site in Poland.
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
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D and Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jan 2024to 30 Jun 2024
- Phase
- Observational
- 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
- Adult
Study population: Women aged 18-45, treated at the University Hospital in Krakow, diagnosed with PCOS confirmed by the Rotterdam criteria, phenotypes A, B, C, D, without other metabolic and endocrine diseases.
Who may be able to join
- age 18-45 years
- PCOS syndrome confirmed by the Rotterdam criteria
Who cannot join
- absence of at least one ovary
- diagnosed and/or treated other metabolic disease
- diagnosed and/or treated other endocrine disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Activity of Chronic Inflammation and Its Impact on Metabolic and Hormonal Parameters in Various 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. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.
Read the detailed description
The study population will be characterized in terms of demographic (age, BMI), gynaecological (cycle length, menstrual pain, abnormal uterine bleeding) and obstetrics (pregnancies, childbirth, miscarriages) data. PCOS syndrome (and its phenotypes: A, B, C, D) will be recognized by the Rotterdam criteria. During hospitalization, blood samples will be collected for scheduled analyses (20 ml of blood in total).
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D, Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters
- Keywords
- PCOS phenotypes, chronic inflammation, metabolic disorders, ovarian reserve
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Diseases
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 C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and DDiagnostic 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 the four study arms
Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parametersDiagnostic test
A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to test the above correlations in the four study arms
| Study group | Role | What they receive |
|---|---|---|
| PCOS phenotype A | clinical and/or biochemical hyperandrogenism (HA) + ovulatory dysfunction (OD) + polycystic ovarian morphology (PCOM) Receives: Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D; Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters | |
| PCOS phenotype B | HA + OD Receives: Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D; Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters | |
| PCOS phenotype C | HA + PCOM Receives: Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D; Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters | |
| PCOS phenotype D | OD + PCOM Receives: Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D; Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes
Measurement and comparison of leukocyte count (n/µL) in peripheral blood in the four PCOS phenotypes
Measured: up to 3 months
Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes
Measurement and comparison of concentrations of CRP (mg/l) in peripheral blood in the four PCOS phenotypes
Measured: up to 3 months
Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes
Measurement and comparison of concentrations of IL-1 (pg/ml) in peripheral blood in the four PCOS phenotypes
Measured: up to 3 months
Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes
Measurement and comparison of concentrations of IL-6 (pg/ml) in peripheral blood in the four PCOS phenotypes
Measured: up to 3 months
Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes
Measurement and comparison of concentrations of IL-10 (pg/ml) in peripheral blood in the four PCOS phenotypes
Measured: up to 3 months
Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes
Measurement and comparison of concentrations of TNF-alpha (pg/ml) in peripheral blood in the four PCOS phenotypes
Measured: up to 3 months
Secondary outcomes (48)
Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: leukocyte count (n/µL)
Measured: up to 3 months
Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes
Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: CRP (mg/l)
Measured: up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes
Evaluation of the correlation between the HOMA-IR and inflammatory parameters: il-1 (pg/ml)
Measured: up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes
Evaluation of the correlation between HOMA-IR value and inflammatory parameters: il-6 (pg/ml)
Measured: up to 3 months
Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Evaluation of the correlation between the concentration of HOMA-IR and inflammatory parameters: il-10 (pg/ml)
Measured: up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: TNF-alpha (pg/ml)
Measured: up to 3 months
Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Evaluation of the correlation between the BMI value and inflammatory parameters: leukocyte count (n/µL)
Measured: up to 3 months
Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes
Evaluation of the correlation between the BMI value and inflammatory parameters: CRP (mg/l)
Measured: up to 3 months
Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes
Evaluation of the correlation between the BMI and inflammatory parameters: il-1 (pg/ml)
Measured: up to 3 months
Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes
Evaluation of the correlation between BMI value and inflammatory parameters: il-6 (pg/ml)
Measured: up to 3 months
Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Evaluation of the correlation between BMI value and inflammatory parameters: il-10 (pg/ml)
Measured: up to 3 months
Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Evaluation of the correlation between the BMI value and inflammatory parameters: TNF-alpha (pg/ml)
Measured: up to 3 months
Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)
Measured: up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: CRP (mg/l)
Measured: up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-1 (pg/ml)
Measured: up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-6 (pg/ml)
Measured: up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-10 (pg/ml)
Measured: up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)
Measured: up to 3 months
Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)
Measured: up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: CRP (mg/l)
Measured: up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-1 (pg/ml)
Measured: up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-6 (pg/ml)
Measured: up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-10 (pg/ml)
Measured: up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)
Measured: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)
Measured: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: CRP (mg/l)
Measured: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)
Measured: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)
Measured: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)
Measured: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)
Measured: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)
Measured: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: CRP (mg/l)
Measured: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)
Measured: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)
Measured: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)
Measured: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)
Measured: up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)
Measured: up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: CRP (mg/l)
Measured: up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)
Measured: up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)
Measured: up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)
Measured: up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)
Measured: up to 3 months
Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: leukocyte count (n/µL)
Measured: up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: CRP (mg/l)
Measured: up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-1 (pg/ml)
Measured: up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-6 (pg/ml)
Measured: up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-10 (pg/ml)
Measured: up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: TNF-alpha (pg/ml)
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Kazimierz Pitynski, Prof., Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300593
- Sponsor's protocol ID
- 1072.6120.292.2022-1
- Status last verified
- Jul 2024
- First submitted
- 2 Mar 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Activity of Chronic Inflammation and Its Impact on Metabolic and Hormonal Parameters in Various PCOS Phenotypes
- ClinicalTrials.gov ID
- NCT06300593
- Acronym / sponsor ID
- 1072.6120.292.2022-1
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS phenotypes, chronic inflammation, metabolic disorders, ovarian reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.
Detailed description
The study population will be characterized in terms of demographic (age, BMI), gynaecological (cycle length, menstrual pain, abnormal uterine bleeding) and obstetrics (pregnancies, childbirth, miscarriages) data. PCOS syndrome (and its phenotypes: A, B, C, D) will be recognized by the Rotterdam criteria. During hospitalization, blood samples will be collected for scheduled analyses (20 ml of blood in total).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PCOS phenotype A | – | Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D, Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parametersclinical and/or biochemical hyperandrogenism (HA) + ovulatory dysfunction (OD) + polycystic ovarian morphology (PCOM) |
| PCOS phenotype B | – | Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D, Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parametersHA + OD |
| PCOS phenotype C | – | Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D, Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parametersHA + PCOM |
| PCOS phenotype D | – | Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D, Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parametersOD + PCOM |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women aged 18-45, treated at the University Hospital in Krakow, diagnosed with PCOS confirmed by the Rotterdam criteria, phenotypes A, B, C, D, without other metabolic and endocrine diseases.
Key inclusion criteria (2 listed)
- age 18-45 years
- PCOS syndrome confirmed by the Rotterdam criteria
Key exclusion criteria (3 listed)
- absence of at least one ovary
- diagnosed and/or treated other metabolic disease
- diagnosed and/or treated other endocrine disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and DA 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 the four study arms | Diagnostic test | PCOS phenotype A, PCOS phenotype B, PCOS phenotype C, PCOS phenotype D |
| Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parametersA venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to test the above correlations in the four study arms | Diagnostic test | PCOS phenotype A, PCOS phenotype B, PCOS phenotype C, PCOS phenotype D |
Primary outcome
Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes
Time frame: up to 3 months
Measurement and comparison of leukocyte count (n/µL) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes
Time frame: up to 3 months
Measurement and comparison of concentrations of CRP (mg/l) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes
Time frame: up to 3 months
Measurement and comparison of concentrations of IL-1 (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes
Time frame: up to 3 months
Measurement and comparison of concentrations of IL-6 (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes
Time frame: up to 3 months
Measurement and comparison of concentrations of IL-10 (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes
Time frame: up to 3 months
Measurement and comparison of concentrations of TNF-alpha (pg/ml) in peripheral blood in the four PCOS phenotypes
48 secondary outcomes
Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time frame: up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazimierz Pitynski, Prof. study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, 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 2 inclusion and 3 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 30 Jul 2024. 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 the four PCOS phenotypes (time frame: up to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.