NCT07396402

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

February 2, 2026

Last Update Submit

February 2, 2026

Conditions

Polycystic Ovary Syndrome (PCOS)Insulin Resistance

Keywords

SCUBE-1SCUBE-3Polycystic Ovary SyndromePCOSInsulin ResistanceInflammationCardiovascular Risk

Outcome Measures

Primary Outcomes (1)

  • Circulating SCUBE-1 levels

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

    At enrollment

Secondary Outcomes (2)

  • Circulating SCUBE-3 levels

    At enrollment

  • Correlation with clinical and laboratory parameters

    At enrollment

Study Arms (3)

Arm 1: PCOS - Normoinsulinemic

EXPERIMENTAL

Description: Women with PCOS and normal insulin sensitivity Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA

Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement

Arm 2: PCOS - Hyperinsulinemic

EXPERIMENTAL

Description: Women with PCOS and insulin resistance Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA

Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement

Arm 3: Healthy Controls

EXPERIMENTAL

Description: Healthy women of reproductive age without PCOS Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA

Diagnostic Test: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement

Interventions

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

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

Arm 1: PCOS - NormoinsulinemicArm 2: PCOS - HyperinsulinemicArm 3: Healthy Controls

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin ResistanceInflammation

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rosanna Apa, MD, PhD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosanna Apa, MD, PhD

CONTACT

+390630155872rosanna.apa@policlinicogemelli.it

Anna Tropea, MD, PhD

CONTACT

+390630155872anna.tropea@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 9, 2026

Study Start

January 15, 2026

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)