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

Ovarian Cysts Clinical Trial

Official title:

Ultrasonographic Evaluation of Ovarian Stroma in PCOS Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05418595
• Other study ID #: 575704
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Ovarian Cysts

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