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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05418595
Other study ID # 575704
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 13, 2022
Est. completion date September 4, 2022

Study information

Verified date September 2022
Source Usak State Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date September 4, 2022
Est. primary completion date September 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 38 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Irem Senyuva Usak

Sponsors (1)

Lead Sponsor Collaborator
Usak State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Makled AK, El Sherbiny M, Elkabarity R. Assessment of ovarian stromal blood flow after metformin treatment in women with polycystic ovary syndrome. Arch Gynecol Obstet. 2014 Apr;289(4):883-91. doi: 10.1007/s00404-013-3057-8. Epub 2013 Nov 7. — View Citation

Ozdemir O, Sari ME, Kalkan D, Koc EM, Ozdemir S, Atalay CR. Comprasion of ovarian stromal blood flow measured by color Doppler ultrasonography in polycystic ovary syndrome patients and healthy women with ultrasonographic evidence of polycystic. Gynecol Endocrinol. 2015 Apr;31(4):322-6. doi: 10.3109/09513590.2014.995617. Epub 2015 Jan 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The superiority of Superb microvascular imaging doppler technique over the conventional doppler techniques 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. 1 month
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