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Ultrasound Three-dimensional Characterization of Ovarian Morphology in Women With Polycystic Ovary Syndrome (PCOS)

Sponsor
University of Cagliari (Other)
Overall Status
Unknown status
CT.gov ID
NCT02402413
Collaborator
(none)
100
Enrollment
1
Arm
6
Duration (Months)

Study Details

Study Description

Brief Summary

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in women of reproductive age. PCOS is considered a syndrome of ovarian dysfunction that is characterized by the heterogeneous clinical manifestation of infrequent or absent menstrual cycles, hyperandrogenism, and polycystic ovarian morphology.

An important ultrasound parameter is the ratio stroma/ovary, the ratio of the volume, evaluated in two-dimensional ultrasound, of the stroma, that secrete androgen, and the ovary. It has been shown that when this ratio is higher than a third the levels of circulating androgens and high. Aim of the present study is to assess whether this ratio, determined with three-dimensional ultrasound, is correlated to the increase of androgens.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound
  • Procedure: Determination of concentrations of androgens
  • Device: Three dimensional ultrasound probe
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: PCOS women

Procedure: Ultrasound
The patients will be subjected to ultrasound bi-dimensional or three-dimensional. Will Be calculated the ratio stroma/volume with both methods
Other Names:
  • Ultrasound evaluation of ovarian morphology

    • Procedure: Determination of concentrations of androgens
    Determination of concentrations of serum levels of circulating androgens

    Device: Three dimensional ultrasound probe
    Capture of ovarian three dimensional volumes

    Outcome Measures

    Primary Outcome Measures

    1. Androgens serum levels in women with ultrasound morphological PCO [up to 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 25 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Self-reported history of infrequent or absent menstrual cycles and/or PCOS ultrasound feature and/or clinical or biochemical hyperandrogenism

    • Did not take hormonal contraception, fertility therapies, or insulin sensitizers in the three months prior to enrollment

    Exclusion Criteria:
    • Pregnancy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Cagliari

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefano Angioni, Associate professor, University of Cagliari
    ClinicalTrials.gov Identifier:
    NCT02402413
    Other Study ID Numbers:
    • PCOSCA
    First Posted:
    Mar 30, 2015
    Last Update Posted:
    Mar 9, 2016
    Last Verified:
    Mar 1, 2016
    Additional relevant MeSH terms:
    Hyperandrogenism
    Androgens

    Study Results

    No Results Posted as of Mar 9, 2016