NCT05104086

Brief Summary

To investigate the value of ultrasound elastography in differentiating endometriomas from ovarian hemorrhagic cysts

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 25, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
Last Updated

November 2, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

October 8, 2021

Last Update Submit

October 22, 2021

Conditions

Ovarian Endometrioma

Keywords

ultrasound elastography

Outcome Measures

Primary Outcomes (1)

  • evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts

    the cut of value of strain ratio in diagnosis of endometrioma and ovarian hemorrhagic cyst

    4 weeks

Study Arms (2)

evaluate the value of ultrasound elastography in dignosis of endometriomas

ACTIVE COMPARATOR

evaluation of endometrioma by ultrasound elastography and will be repeated after 4 weeks

Device: ultrasound elastography

evaluate the value of ultrasound elastography in ovarian hemorrhagic cysts

ACTIVE COMPARATOR

revaluation of ovarian hemorrhagic cyst by ultrasound elastography and noticing the change of values

Device: ultrasound elastography

Interventions

ultrasound elastographyDEVICE

strain ratio and resistivity index

evaluate the value of ultrasound elastography in dignosis of endometriomasevaluate the value of ultrasound elastography in ovarian hemorrhagic cysts

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient suspected to have endometrioma or hemorrhagic ovarian cysts.

You may not qualify if:

  • Simple cysts which were defined as a sonolucent thin-walled (\<3 mm thick) cyst larger than 3 cm in diameter without septations or papillary projections \[12\].
  • Hemorrhagic cysts containing septations or mural nodules with detectable flow on Doppler ultrasonography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35111, Egypt

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Alaa mosbah, professor

    Mansoura university faculty of medicine,obestetric and gynecology department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hala hafez, resident

CONTACT

00201027292006halahafez193@gmail.com

alaa mosbah, professor

CONTACT

alaamosbah@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single investigator
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2021

First Posted

November 2, 2021

Study Start

December 25, 2020

Primary Completion

November 25, 2021

Study Completion

December 25, 2021

Last Updated

November 2, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)