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NCT Number: NCT07396402

SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement

Diagnostic Test

Blood sample collection performed specifically for research purposes to measure circulating SCUBE-1 and SCUBE-3 levels using enzyme-linked immunosorbent assay (ELISA).

Primary outcomes

  1. Circulating SCUBE-1 levels

    Time frame: At enrollment

    Comparison of SCUBE-1 plasma concentrations among normoinsulinemic PCOS, hyperinsulinemic PCOS, and healthy controls

Secondary outcomes

  1. Circulating SCUBE-3 levels

    Time frame: At enrollment

    Comparison of SCUBE-3 plasma concentrations among study groups

  2. Correlation with clinical and laboratory parameters

    Time frame: At enrollment

    Association between SCUBE-1 and SCUBE-3 levels and clinical (age, BMI, hirsutism, acne, menstrual irregularities) and laboratory variables (lipid profile, androgen levels)

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Tropea, MD, PhD

CONTACT

[email protected]

+390630155872

Rosanna Apa, MD, PhD

CONTACT

[email protected]

+390630155872

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study 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.

Acronym: IPSOS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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