Polycystic Ovary Syndrome (PCOS)IPSOSNCT07396402
SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)
A study testing Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement in people with Polycystic Ovary Syndrome (PCOS) and Insulin Resistance, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This study investigates circulating levels of SCUBE-1 and SCUBE-3 proteins in women with polycystic ovary syndrome (PCOS) compared with healthy controls. Differences between normoinsulinemic and hyperinsulinemic PCOS subgroups will be evaluated, as well as correlations with clinical and metabolic parameters related to… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Insulin Resistance
- What is being tested?
- Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2026to 1 Jul 2026
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects aged 18-35 years
- Diagnosis of polycystic ovary syndrome (normoinsulinemic or hyperinsulinemic)
- Availability of basal hormonal evaluation and oral glucose tolerance test
- Healthy women for control group
- Written informed consent
Who cannot join
- Pregnancy
- History of cardiovascular disease
- Diabetes mellitus or impaired glucose tolerance
- Hypertension
- Significant hepatic or renal disease
- Other endocrine disorders
Show all 12Show fewer
- Neoplastic diseases
- Psychiatric disorders
- Autoimmune diseases
- Shift work
- Obesity
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Rosanna Apa, MD, PhD, +390630155872, rosanna.apa@policlinicogemelli.it
About this study
Official title: Study of Scube-1 and Scube-3 in Polycystic Ovary Syndrome (PCOS) and Their Possible Use as Inflammatory Markers and as a Link Between PCOS and Cardiovascular Events.
This study investigates circulating levels of SCUBE-1 and SCUBE-3 proteins in women with polycystic ovary syndrome (PCOS) compared with healthy controls. Differences between normoinsulinemic and hyperinsulinemic PCOS subgroups will be evaluated, as well as correlations with clinical and metabolic parameters related to inflammation and cardiovascular risk.
Read the detailed description
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is frequently associated with insulin resistance, chronic low-grade inflammation, and increased cardiovascular risk.
SCUBE proteins (Signal peptide-CUB-EGF domain-containing proteins) are recently identified molecules involved in inflammation, angiogenesis, and platelet activation. Their role in PCOS has not been fully elucidated.
This interventional, non-randomized study will measure circulating SCUBE-1 and SCUBE-3 levels in women with PCOS and healthy controls. PCOS patients will be stratified into normoinsulinemic and hyperinsulinemic subgroups based on previously performed metabolic assessments. Blood samples will be collected during routine clinical practice and analyzed using ELISA assays. The study aims to assess SCUBE proteins as potential biomarkers of inflammation and cardiovascular risk in PCOS.
- Being tested
- Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement
- Keywords
- SCUBE-1, SCUBE-3, Polycystic Ovary Syndrome, PCOS, Insulin Resistance, Inflammation, Cardiovascular Risk
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample Collection for SCUBE-1 and SCUBE-3 MeasurementDiagnostic test
Blood sample collection performed specifically for research purposes to measure circulating SCUBE-1 and SCUBE-3 levels using enzyme-linked immunosorbent assay (ELISA).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: PCOS - Normoinsulinemic | Experimental | Description: Women with PCOS and normal insulin sensitivity Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA Receives: Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement |
| Arm 2: PCOS - Hyperinsulinemic | Experimental | Description: Women with PCOS and insulin resistance Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA Receives: Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement |
| Arm 3: Healthy Controls | Experimental | Description: Healthy women of reproductive age without PCOS Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA Receives: Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating SCUBE-1 levels
Comparison of SCUBE-1 plasma concentrations among normoinsulinemic PCOS, hyperinsulinemic PCOS, and healthy controls
Measured: At enrollment
Secondary outcomes (2)
Circulating SCUBE-3 levels
Comparison of SCUBE-3 plasma concentrations among study groups
Measured: At enrollment
Correlation with clinical and laboratory parameters
Association between SCUBE-1 and SCUBE-3 levels and clinical (age, BMI, hirsutism, acne, menstrual irregularities) and laboratory variables (lipid profile, androgen levels)
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start15 Jan 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosanna Apa, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396402
- Sponsor's protocol ID
- 7725
- Acronym
- IPSOS
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Scube-1 and Scube-3 in Polycystic Ovary Syndrome (PCOS) and Their Possible Use as Inflammatory Markers and as a Link Between PCOS and Cardiovascular Events.
- ClinicalTrials.gov ID
- NCT07396402
- Acronym / sponsor ID
- IPSOS / 7725
- Keywords
- SCUBE-1, SCUBE-3, Polycystic Ovary Syndrome, PCOS, Insulin Resistance, Inflammation, Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Feb 2026 (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.
This study investigates circulating levels of SCUBE-1 and SCUBE-3 proteins in women with polycystic ovary syndrome (PCOS) compared with healthy controls. Differences between normoinsulinemic and hyperinsulinemic PCOS subgroups will be evaluated, as well as correlations with clinical and metabolic parameters related to inflammation and cardiovascular risk.
Detailed description
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is frequently associated with insulin resistance, chronic low-grade inflammation, and increased cardiovascular risk.
SCUBE proteins (Signal peptide-CUB-EGF domain-containing proteins) are recently identified molecules involved in inflammation, angiogenesis, and platelet activation. Their role in PCOS has not been fully elucidated.
This interventional, non-randomized study will measure circulating SCUBE-1 and SCUBE-3 levels in women with PCOS and healthy controls. PCOS patients will be stratified into normoinsulinemic and hyperinsulinemic subgroups based on previously performed metabolic assessments. Blood samples will be collected during routine clinical practice and analyzed using ELISA assays. The study aims to assess SCUBE proteins as potential biomarkers of inflammation and cardiovascular risk in PCOS.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: PCOS - Normoinsulinemic | Experimental | Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 MeasurementDescription: Women with PCOS and normal insulin sensitivity Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA |
| Arm 2: PCOS - Hyperinsulinemic | Experimental | Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 MeasurementDescription: Women with PCOS and insulin resistance Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA |
| Arm 3: Healthy Controls | Experimental | Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 MeasurementDescription: Healthy women of reproductive age without PCOS Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects aged 18-35 years
- Diagnosis of polycystic ovary syndrome (normoinsulinemic or hyperinsulinemic)
- Availability of basal hormonal evaluation and oral glucose tolerance test
- Healthy women for control group
- Written informed consent
Key exclusion criteria (12 listed)
- Pregnancy
- History of cardiovascular disease
- Diabetes mellitus or impaired glucose tolerance
- Hypertension
- Significant hepatic or renal 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 |
|---|---|---|
| Blood Sample Collection for SCUBE-1 and SCUBE-3 MeasurementBlood sample collection performed specifically for research purposes to measure circulating SCUBE-1 and SCUBE-3 levels using enzyme-linked immunosorbent assay (ELISA). | Diagnostic test | Arm 1: PCOS - Normoinsulinemic, Arm 2: PCOS - Hyperinsulinemic, Arm 3: Healthy Controls |
Primary outcome
Circulating SCUBE-1 levels
Time frame: At enrollment
Comparison of SCUBE-1 plasma concentrations among normoinsulinemic PCOS, hyperinsulinemic PCOS, and healthy controls
2 secondary outcomes
Circulating SCUBE-3 levels
Time frame: At enrollment
Correlation with clinical and laboratory parameters
Time frame: At enrollment
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 9 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Rosanna Apa, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement in people with Polycystic Ovary Syndrome (PCOS) and Insulin Resistance, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 9 Feb 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 Italy. 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 Rosanna Apa, MD, PhD (+390630155872, rosanna.apa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating SCUBE-1 levels (time frame: At enrollment). 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 9 Feb 2026.