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Trial record 61 of 107 for:    "21-hydroxylase deficiency"

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

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ClinicalTrials.gov Identifier: NCT02402413
Recruitment Status : Unknown
Verified March 2016 by Stefano Angioni, University of Cagliari.
Recruitment status was:  Not yet recruiting
First Posted : March 30, 2015
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Stefano Angioni, 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.


Condition or disease Intervention/treatment Phase
PCOS Hyperandrogenism Procedure: Ultrasound Procedure: Determination of concentrations of androgens Device: Three dimensional ultrasound probe Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : June 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016


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 Name: 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




Primary Outcome Measures :
  1. Androgens serum levels in women with ultrasound morphological PCO [ Time Frame: up to 1 year ]


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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Publications of Results:
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Responsible Party: Stefano Angioni, Associate professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT02402413     History of Changes
Other Study ID Numbers: PCOSCA
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Adrenogenital Syndrome
Hyperandrogenism
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs