NCT07396402

SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Polycystic Ovary Syndrome (PCOS)
• Insulin Resistance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement	Blood sample collection performed specifically for research purposes to measure circulating SCUBE-1 and SCUBE-3 levels using enzyme-linked immunosorbent assay (ELISA).

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Italy