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

Primary Purpose

PCOS, Hyperandrogenism

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound
Determination of concentrations of androgens
Three dimensional ultrasound probe
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for PCOS

Eligibility Criteria

15 Years - 25 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PCOS women

    Arm Description

    Outcomes

    Primary Outcome Measures

    Androgens serum levels in women with ultrasound morphological PCO

    Secondary Outcome Measures

    Full Information

    First Posted
    March 18, 2015
    Last Updated
    March 8, 2016
    Sponsor
    University of Cagliari
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02402413
    Brief Title
    Ultrasound Three-dimensional Characterization of Ovarian Morphology in Women With Polycystic Ovary Syndrome (PCOS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Cagliari

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PCOS, Hyperandrogenism

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PCOS women
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound
    Other Intervention Name(s)
    Ultrasound evaluation of ovarian morphology
    Intervention Description
    The patients will be subjected to ultrasound bi-dimensional or three-dimensional. Will Be calculated the ratio stroma/volume with both methods
    Intervention Type
    Procedure
    Intervention Name(s)
    Determination of concentrations of androgens
    Intervention Description
    Determination of concentrations of serum levels of circulating androgens
    Intervention Type
    Device
    Intervention Name(s)
    Three dimensional ultrasound probe
    Intervention Description
    Capture of ovarian three dimensional volumes
    Primary Outcome Measure Information:
    Title
    Androgens serum levels in women with ultrasound morphological PCO
    Time Frame
    up to 1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11476780
    Citation
    Fulghesu AM, Ciampelli M, Belosi C, Apa R, Pavone V, Lanzone A. A new ultrasound criterion for the diagnosis of polycystic ovary syndrome: the ovarian stroma/total area ratio. Fertil Steril. 2001 Aug;76(2):326-31. doi: 10.1016/s0015-0282(01)01919-7.
    Results Reference
    result

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

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