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Assessment of the Uterus Using Ultrasonographic Elastography in Women with Dysmenorrhea

Assessment of the Uterus Using Ultrasonographic Elastography in Women with Dysmenorrhea

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06606834
Enrollment
100
Registered
2024-09-23
Start date
2024-09-20
Completion date
2025-06-15
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhea, Sonoelastography

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.

Interventions

DIAGNOSTIC_TESTsonoelastography

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.

Sponsors

Ufuk University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
SWE Tecnique1 yearThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026