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NCT Number: NCT06606834

Assessment of the Uterus Using Ultrasonographic Elastography in Women with Dysmenorrhea

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. SWE Tecnique

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ufuk University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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