Assessment of the Uterus Using Ultrasonographic Elastography in Women with Dysmenorrhea

NCT06606834 | Not Yet Recruiting

• 1 other identifier: 24.06.11.02/01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhea; Sonoelastography

Outcome Measures

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.

  1 year

Interventions

sonoelastography DIAGNOSTIC_TEST

Elasticity 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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

dysmenorrhea patient group

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Individuals who have delivered via normal spontaneous vaginal delivery or cesarean section.

Sponsors & Collaborators

• Ufuk University: lead

Study Sites (1)

Ufuk University

Ankara, Ankara, 06090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 23, 2024
• Study Start: September 20, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

TU (1)