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Completed

NCT Number: NCT05418595

Ultrasonographic Evaluation of Ovarian Stromal Vascularity in Women With Polycystic Ovary Syndrome (PCOS)

The most common endocrine condition in reproductive women is polycystic ovary syndrome. It has a prevalence of 5-10%. According to the Rotterdam criteria, oligo/anovulation, clinic or biochemical hyperandrogenism, PCOS morphology in ultrasonography, and the presence of these two criteria are required for diagnosis.

The echogenicity of the ovarian stroma, vascularity, ovarian size, cystic pattern density, and subcortical organization of cysts are all significant considerations in ultrasonographic evaluation.

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Key information

About this study

Retrospective archive study.

In the years 2018-2019, the ultrasonographic archives of PCOS women will be analyzed retrospectively in the Radiology department of Usak Education and Research Hospital. Ultrasonographic (Two-dimensional ultrasonography , conventional and other doppler) measurements of ovaries will be assessed in ultrasonographic data. Patient's data ( Menstrual cycle, androgenic findings, age, BMI etc..) will be obtained on the hospital records, PCOS patient's phenotype will be evaluated according to National Institutes Health (NIH) recommendations.

The ovarian ultrasonographic findings of PCOS women will be compared.

This study approved by Usak University Medical Faculty Ethical Committee April,06,2022.

The Ethical Committee decision number is 57-57-04.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Reproductive period According to Rotterdam criteria PCOS women.

Exclusion criteria

Women have not PCOS criteria, Non-reproductive period Pregnancy Postpartum Ovarian mass Underwent ovarian surgery.

Treatment and study plan

Primary outcomes

  1. The superiority of Superb microvascular imaging doppler technique over the conventional doppler techniques

    Time frame: 1 month

    The Toshiba Aplio 500 ultrasonography tool (Toshiba, Aplio 500, Tokyo, Japan) was used in the Radiology Policlinic Ultrasonography Unit to perform ultrasonography using a 1-6 MHz convex probe. After scanning the lesion with TAUSG, 5-12 second-long video pictures were recorded. The ovarian stromal vascularity was defined according to the International Ovarian Tumor Analysis (IOTA) group criteria. Four categories of endometrial blood flow were identified: No coloration in grade 1, one or more punctate colorations in grade 2, one linear coloring or several (>5) punctate colorations in grade 3, and multiple linear colorations in grade 4 of the ovary. [14]. The vascularization rating was done independently using CDI, PDI, cSMI, and mSMI techniques. In all patients, the ovarian morphologic features were recorded for the both ovaries. Three radiologists analyzed the captured video pictures and assigned a consensus rating.

Sponsors and collaborators

Lead sponsor

Usak State Hospital

Other

Registry information

Official study title

Ultrasonographic Evaluation of Ovarian Stroma in PCOS Women

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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