Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 1:15 AM
Study NCT ID:
NCT07396402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
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.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPSOS
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: