NCT05418595

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

June 13, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

June 8, 2022

Last Update Submit

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

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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)

Location

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: 25558942BACKGROUND
  • 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.

    PMID: 24196302BACKGROUND

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • İrem Şenyuva, MD

    USAK TRAINING AND RESEARCH HOSPITAL, DEPARTMENT OF OBSTETRICS AND GYNECOLOGY,TURKEY

    PRINCIPAL INVESTIGATOR

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

Locations