Assessment of the Uterus Using Ultrasonographic Elastography in Women with Dysmenorrhea

Not yet recruiting

• Conditions: Primary Dysmenorrhea

• Registration Number: NCT06606834
• Lead Sponsor: Ufuk University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study Start: 2024-09-20
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Women aged 18-40 years.
2. Women with primary dysmenorrhea who are willing to participate in the study.
3. Women without primary or secondary dysmenorrhea who agree to participate as a control group.

Exclusion Criteria

1. Women with secondary dysmenorrhea.
2. Patients with underlying uterine or adnexal pathologies (e.g., endometrial polyps, adenomyosis, uterine fibroids, adnexal masses, ovarian pathologies and cysts) identified via ultrasonography.
3. Individuals with a history of uterine surgery.
4. Individuals with a history of pelvic surgery.
5. Individuals who have delivered via normal spontaneous vaginal delivery or cesarean section.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SWE Tecnique	1 year	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.

Trial Locations

Locations (1)

Ufuk University; 🇹🇷 Ankara, Turkey