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

Not Applicable

• Conditions: PCOS; Hyperandrogenism
• Interventions: Procedure: Ultrasound; Procedure: Determination of concentrations of androgens; Device: Three dimensional ultrasound probe

• Registration Number: NCT02402413
• Lead Sponsor: University of Cagliari

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-03-30
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09
• Study Start: 2016-06
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCOS women	Determination of concentrations of androgens	-
PCOS women	Ultrasound	-
PCOS women	Three dimensional ultrasound probe	-

Primary Outcome Measures

Name	Time	Method
Androgens serum levels in women with ultrasound morphological PCO	up to 1 year