Ultrasonographic Evaluation of Ovarian Stromal Vascularity in Women With Polycystic Ovary Syndrome (PCOS)
1 other identifier
observational
42
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedStudy Start
First participant enrolled
June 13, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2022
CompletedSeptember 21, 2022
September 1, 2022
3 months
June 8, 2022
September 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Group-1
PCOS patients intraovarian stromal conventional and SMI doppler findings
Eligibility Criteria
Reproductive period, PCOS women
You may qualify if:
- Reproductive period According to Rotterdam criteria PCOS women.
You may not qualify if:
- Women have not PCOS criteria, Non-reproductive period Pregnancy Postpartum Ovarian mass Underwent ovarian surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
İrem Şenyuva
Uşak, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 25558942BACKGROUNDMakled 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.
PMID: 24196302BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
İrem Şenyuva, MD
USAK TRAINING AND RESEARCH HOSPITAL, DEPARTMENT OF OBSTETRICS AND GYNECOLOGY,TURKEY
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Usak Training and Research hospital
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 14, 2022
Study Start
June 13, 2022
Primary Completion
September 4, 2022
Study Completion
September 4, 2022
Last Updated
September 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share