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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02402413
Enrollment
100
Registered
2015-03-30
Start date
2016-06-30
Completion date
2016-12-31
Last updated
2016-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperandrogenism, PCOS

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.

Interventions

PROCEDUREUltrasound

The patients will be subjected to ultrasound bi-dimensional or three-dimensional. Will Be calculated the ratio stroma/volume with both methods

PROCEDUREDetermination of concentrations of androgens

Determination of concentrations of serum levels of circulating androgens

DEVICEThree dimensional ultrasound probe

Capture of ovarian three dimensional volumes

Sponsors

University of Cagliari
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 25 Years
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

Design outcomes

Primary

MeasureTime frame
Androgens serum levels in women with ultrasound morphological PCOup to 1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026