SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome (PCOS), Insulin Resistance. Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- 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).
Primary outcome measures
- Circulating SCUBE-1 levels [Time frame: At enrollment]
Secondary outcome measures (2)
- Circulating SCUBE-3 levels [Time frame: At enrollment]
- Correlation with clinical and laboratory parameters [Time frame: At enrollment]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Pregnancy
- History of cardiovascular disease
- Diabetes mellitus or impaired glucose tolerance
- Hypertension
- Significant hepatic or renal disease
- Other endocrine disorders
- Neoplastic diseases
- Psychiatric disorders
- Autoimmune diseases
- Shift work
- Obesity
- Refusal to sign informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Identifiers
NCT: NCT07396402 · 7725