Assessment of the Uterus Using Ultrasonographic Elastography in Women with Dysmenorrhea
ConditionPrimary Dysmenorrhea
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorUfuk University
About this trial
The aim of this study is to perform sonoelastographic assessment of the uterus in patients diagnosed with primary dysmenorrhea and to compare these measurements with sonoelastographic evaluations of the uteri in asymptomatic individuals. This will enable, for the first time, the demonstration of whether the elasticity of the myometrial tissue contributes to the etiology of primary dysmenorrhea.
Secondary Objectives: To determine whether there is a correlation between the severity of primary dysmenorrhea and ultrasonographic markers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 18-40 years.
Women with primary dysmenorrhea who are willing to participate in the study.
Women without primary or secondary dysmenorrhea who agree to participate as a control group.
Disqualifiers
Women with secondary dysmenorrhea.
Patients with underlying uterine or adnexal pathologies (e.g., endometrial polyps, adenomyosis, uterine fibroids, adnexal masses, ovarian pathologies and cysts) identified via ultrasonography.
Individuals with a history of uterine surgery.
Individuals with a history of pelvic surgery.
Trial population
dysmenorrhea patient group
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
sonoelastography
Diagnostic testElasticity is defined as the ability of an organ or tissue to return to its original shape after being deformed by an applied force or stress. Based on this principle, sonoelastography is a technique used to assess the elasticity of tissues and organs during ultrasonography. This assessment allows measurement of changes in stiffness of soft tissues following physiological or pathological processes.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
SWE Tecnique
The SWE technique, available in the ultrasound device software, will be used with no additional cost to the patient or institution. With SWE, at least 3 different measurements will be taken from the closest myometrial layer in both axial and sagittal planes, and both speed and elasticity values will be recorded as minimum, maximum, and mean values. The speed of shear waves increases as tissue hardness increases, therefore there is a direct proportion between tissue elasticity and velocity. The elasticity of the tissue is measured with the formula G(tissue elasticity)= ρ(tissue density)c²(shear wave velocity), also called shear modulus. While tissue elasticity is obtained in Kpa, the unit of tissue density is kg/m³ and the shear wave velocity is expressed in m/sn.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: