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Not yet recruitingNCT06606834Updated Sep 23, 2024

Assessment of the Uterus Using Ultrasonographic Elastography in Women with Dysmenorrhea

An observational study in Primary Dysmenorrhea, sponsored by Ufuk University. Not yet recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Ufuk University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Primary Dysmenorrhea

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Keywords

  • Dysmenorrhea
  • Sonoelastography
03

In context

Dysmenorrhea

430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.

This study's planned enrollment of 100 is close to the median of 107 across 58 observational studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

Ufuk University is the lead sponsor of 41 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

dysmenorrhea patient group

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

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.

06

What researchers measure

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 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06606834
Lead sponsor
Ufuk University
Responsible party
Bilge Pinar Keskinsoy (MD, Ufuk University) — Principal investigator
First posted
Sep 23, 2024
Start date
Sep 20, 2024 (estimated)
Primary completion
Jun 15, 2025 (estimated)
Completion
Jun 15, 2025 (estimated)
Last update
Sep 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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