Assessment of the Uterus Using Ultrasonographic Elastography in Women with Dysmenorrhea

NCT ID: NCT06606834

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-20

Study Completion Date

2025-06-15

Brief Summary

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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

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Conditions

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Primary Dysmenorrhea

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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sonoelastography

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ufuk University

OTHER

Sponsor Role lead

Responsible Party

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Bilge Pinar Keskinsoy

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ufuk University

Ankara, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Facility Contacts

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Bilge P Keskinsoy

Role: primary

+905069552050

Other Identifiers

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24.06.11.02/01

Identifier Type: -

Identifier Source: org_study_id

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