SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study ID
- NCT07396402
- Status
- Not Yet Recruiting
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Conditions
- Insulin Resistance
- Polycystic Ovary Syndrome (PCOS)
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 35 Years
- Healthy Volunteers
- Accepted
Interventions
- Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement — DIAGNOSTIC_TESTBlood sample collection performed specifically for research purposes to measure circulating SCUBE-1 and SCUBE-3 levels using enzyme-linked immunosorbent assay (ELISA).
Study Details
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.
Key Dates
- First listed
- Feb 9, 2026
- Start date
- Jan 15, 2026
- Status verified
- Jan 2026
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2026
Study Design
- Enrollment
- 56 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Arm 1: PCOS - NormoinsulinemicDescription: Women with PCOS and normal insulin sensitivity Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA
- Experimental: Arm 2: PCOS - HyperinsulinemicDescription: Women with PCOS and insulin resistance Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA
- Experimental: Arm 3: Healthy ControlsDescription: Healthy women of reproductive age without PCOS Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA
Primary Outcome Measure
Circulating SCUBE-1 levels [ Time Frame: At enrollment ]
Central Contacts
- Rosanna Apa, MD, PhD+390630155872
- Anna Tropea, MD, PhD+390630155872
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