Reproductive AgeNCT06793085
Pro- and Anti-inflammatory Cytokines in PCOS
An observational study of Reproductive Age and PCOS (Polycystic Ovary Syndrome), run by Jagiellonian University at 1 site in Poland.
Trial summary
The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Age, PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Measurement of interleukin-6 (il-6) concentration in blood serum, Measurement of fasting tumor necrosis factor α (TNF-α) concentration and Measurement of interleukin-18 (il-18) concentration
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Study population: women aged 18-45 years, managed for menstrual irregularities, infertility or for routine check-up
Who may be able to join
- women aged 18-45 years
Who cannot join
- previous removal of at least one ovary
- treated diabetes of any type
- diagnosed and treated metabolic diseases
- diagnosed and treated autoimmune diseases
- diagnosed and treated autoinflammatory diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robert Jach, Prof., Ph.D., M.D. contact
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University
Krakow
Iwona Gawron, Ph.D., M.D., iwona.gawron@uj.edu.pl
About this study
Official title: Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS
The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).
Read the detailed description
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women of reproductive age, which, in addition to menstrual disorders and infertility due to anovulation, is characterized by insulin resistance (IR). The metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The severity of IR in women with PCOS is linked to abdominal obesity. There is an urgent need to identify more precise and universal markers of insulin resistance than the HOMA-IR index or glucose tolerance tests, which are intended to identify existing disorders rather than predispositions. Additionally, there is a need to investigate the balance of pro-inflammatory and anti-inflammatory parameters in PCOS and their relationship with insulin resistance, which is responsible for the development of adverse health complications.
The objective of this study is to measure and compare the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, and the anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).
Tests will be conducted using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. The concentrations of the substances under investigation will be measured and compared among the three study groups. Statistical analysis will be performed using SPSS Statistics software.
- Conditions
- Reproductive Age, PCOS (Polycystic Ovary Syndrome)
- Being tested
- Measurement of interleukin-6 (il-6) concentration in blood serum, Measurement of fasting tumor necrosis factor α (TNF-α) concentration, Measurement of interleukin-18 (il-18) concentration, Measurement of interleukin-4 (il-4) concentration
- Keywords
- menstrual disorders, chronic inflammation, insulin resistance, metabolic syndrome, Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome, Menstruation Disturbances, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of interleukin-6 (il-6) concentration in blood serumDiagnostic test
Measurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum
Measurement of fasting tumor necrosis factor α (TNF-α) concentrationDiagnostic test
Measurement of fasting tumor necrosis factor α concentration in fasting venous blood serum
Measurement of interleukin-18 (il-18) concentrationDiagnostic test
Measurement of interleukin-18 (il-18) concentration in fasting venous blood serum
Measurement of interleukin-4 (il-4) concentrationDiagnostic test
Measurement of interleukin-4 (il-4) concentration in fasting venous blood plasma
| Study group | Role | What they receive |
|---|---|---|
| Polycystic ovary syndrome (PCOS)+ insulin resistance (IR) | Not described Receives: Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum; Diagnostic Test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration; Diagnostic Test: Measurement of interleukin-18 (il-18) concentration; Diagnostic Test: Measurement of interleukin-4 (il-4) concentration | |
| Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR) | Not described Receives: Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum; Diagnostic Test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration; Diagnostic Test: Measurement of interleukin-18 (il-18) concentration; Diagnostic Test: Measurement of interleukin-4 (il-4) concentration | |
| No PCOS | Not described Receives: Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum; Diagnostic Test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration; Diagnostic Test: Measurement of interleukin-18 (il-18) concentration; Diagnostic Test: Measurement of interleukin-4 (il-4) concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Il-6 concentration
Measurement and comparison of serum interleukin-6 (il-6) concentration expressed in [pg/ml] in three research groups
Measured: up to 6 months
Il-18 concentration
Measurement and comparison of serum interleukin-18 (il-18) concentration expressed in [pg/ml] in three research groups
Measured: up to 6 months
Il-4 concentration
Measurement and comparison of serum interleukin-4 (il-4) concentration expressed in [pg/ml] in three research groups
Measured: up to 6 months
TNF-α concentration
Measurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in [pg/ml] in three research groups
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.
- First posted27 Jan 2025
- Study start20 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive AgeStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Kazimierz Pityński, Prof., Ph.D., M.D., Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793085
- Sponsor's protocol ID
- 1072.6120.44.2024-2
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2025
- Last updated
- 18 Mar 2026
- 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS
- ClinicalTrials.gov ID
- NCT06793085
- Acronym / sponsor ID
- 1072.6120.44.2024-2
- Conditions
- Reproductive Age, PCOS (Polycystic Ovary Syndrome)
- Keywords
- menstrual disorders, chronic inflammation, insulin resistance, metabolic syndrome, Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 2025 (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.
The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).
Detailed description
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women of reproductive age, which, in addition to menstrual disorders and infertility due to anovulation, is characterized by insulin resistance (IR). The metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The severity of IR in women with PCOS is linked to abdominal obesity. There is an urgent need to identify more precise and universal markers of insulin resistance than the HOMA-IR index or glucose tolerance tests, which are intended to identify existing disorders rather than predispositions. Additionally, there is a need to investigate the balance of pro-inflammatory and anti-inflammatory parameters in PCOS and their relationship with insulin resistance, which is responsible for the development of adverse health complications.
The objective of this study is to measure and compare the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, and the anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).
Tests will be conducted using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. The concentrations of the substances under investigation will be measured and compared among the three study groups. Statistical analysis will be performed using SPSS Statistics software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polycystic ovary syndrome (PCOS)+ insulin resistance (IR) | – | Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum, Diagnostic Test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration, Diagnostic Test: Measurement of interleukin-18 (il-18) concentration, Diagnostic Test: Measurement of interleukin-4 (il-4) concentration |
| Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR) | – | Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum, Diagnostic Test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration, Diagnostic Test: Measurement of interleukin-18 (il-18) concentration, Diagnostic Test: Measurement of interleukin-4 (il-4) concentration |
| No PCOS | – | Diagnostic Test: Measurement of interleukin-6 (il-6) concentration in blood serum, Diagnostic Test: Measurement of fasting tumor necrosis factor α (TNF-α) concentration, Diagnostic Test: Measurement of interleukin-18 (il-18) concentration, Diagnostic Test: Measurement of interleukin-4 (il-4) concentration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women aged 18-45 years, managed for menstrual irregularities, infertility or for routine check-up
Key inclusion criteria (1 listed)
- women aged 18-45 years
Key exclusion criteria (5 listed)
- previous removal of at least one ovary
- treated diabetes of any type
- diagnosed and treated metabolic diseases
- diagnosed and treated autoimmune diseases
- diagnosed and treated autoinflammatory diseases
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 of interleukin-6 (il-6) concentration in blood serumMeasurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum | Diagnostic test | No PCOS, Polycystic ovary syndrome (PCOS)+ insulin resistance (IR), Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR) |
| Measurement of fasting tumor necrosis factor α (TNF-α) concentrationMeasurement of fasting tumor necrosis factor α concentration in fasting venous blood serum | Diagnostic test | No PCOS, Polycystic ovary syndrome (PCOS)+ insulin resistance (IR), Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR) |
| Measurement of interleukin-18 (il-18) concentrationMeasurement of interleukin-18 (il-18) concentration in fasting venous blood serum | Diagnostic test | No PCOS, Polycystic ovary syndrome (PCOS)+ insulin resistance (IR), Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR) |
| Measurement of interleukin-4 (il-4) concentrationMeasurement of interleukin-4 (il-4) concentration in fasting venous blood plasma | Diagnostic test | No PCOS, Polycystic ovary syndrome (PCOS)+ insulin resistance (IR), Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR) |
Primary outcome
Il-6 concentration
Time frame: up to 6 months
Measurement and comparison of serum interleukin-6 (il-6) concentration expressed in [pg/ml] in three research groups
Il-18 concentration
Time frame: up to 6 months
Measurement and comparison of serum interleukin-18 (il-18) concentration expressed in [pg/ml] in three research groups
Il-4 concentration
Time frame: up to 6 months
Measurement and comparison of serum interleukin-4 (il-4) concentration expressed in [pg/ml] in three research groups
TNF-α concentration
Time frame: up to 6 months
Measurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in [pg/ml] in three research groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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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.
Robert Jach, Prof., Ph.D., M.D. contact
Kazimierz Pityński, Prof., Ph.D., M.D. 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 Reproductive Age and PCOS (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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iwona Gawron, Ph.D., M.D. (+48 124248570, iwona.gawron@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Il-6 concentration (time frame: up to 6 months). The study lists 4 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 18 Mar 2026.