- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06223464
Evaluation of the Relationship Between Adenomyosis and Elastographic Properties of the Cervix
Study Overview
Status
Conditions
Detailed Description
Adenomyosis is the proliferation of endometrial gland and stroma within the myometrium of the uterus. Its prevalence varies between 10% and 40% in epidemiologic data. It often causes painful menstruation, pelvic pain and other gynecologic symptoms. While adenomyosis may be mild in some patients, it may show infiltrative and severe invasion in others. Advanced cases may be resistant to medical treatment and may affect nearby organs, which makes surgical treatment quite complicated. Therefore, early diagnosis of the disease is important for clinical practice. Global enlargement of the uterus, dysmenorrhea (painful menstruation), menorrhagia, abnormal uterine bleeding and pelvic pain are considered typical clinical symptoms of adenomyosis. However, it should be kept in mind that these symptoms coincide with the histologic diagnosis in a very small proportion of cases, 22% to 65%. The diagnosis and treatment of adenomyosis is complex and therefore there is a need to develop better diagnostic tools and treatment strategies for the management of patients. In this context, new imaging modalities such as cervical elastography may be of potential importance.
Our main hypothesis is that cervical elastography values will be significantly higher in patients with adenomyosis compared to patients without adenomyosis. Our secondary hypothesis is that cervical elastography values will be related to the severity and process of adenomyosis and may be an indicator to predict the symptoms and complications of adenomyosis.
The advantages of Cervical Elastography are the following:
It is non-invasive: Cervical Elastography is performed using ultrasound technology and has no known harm. It stands as a potentially safe method compared to existing invasive tests.
Cost-effective and easy to perform: Cervical Elastography is a procedure performed using existing ultrasound equipment at no separate cost. Therefore, it can be easily performed and repeated in clinical settings.
Fast Results: Cervical Elastography provides fast results by acquiring images in real time. This indicates that cervical elastography can be a valuable diagnostic tool in emergency situations or when rapid decision-making is required.
A potential predictive tool: The results of this study may indicate that the value of cervical elastography is a potential tool for predicting adenomyosis. It may be an important step to develop early diagnosis and treatment strategies to improve health in patients with adenomyosis.
The aim of this study was to compare cervical elastography values between groups of patients with and without adenomyosis and to evaluate the potential of cervical elastography values (quantified in kPa) in the diagnosis of adenomyosis.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Yenimahalle
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Ankara, Yenimahalle, Turkey, 06000
- Ankara Etlik City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female patients between 18-45 years of age who volunteered and consented to the reproductive period study
- Patients diagnosed with adenomyosis using MUSA criteria
Exclusion Criteria:
- Pregnancy status
- Pelvic/Cervical infection, pathology and anomalies
- History of cervical surgery
- Diagnosis and findings of systemic disease
- Chronic drug use
- Advanced maternal obesity preventing measurement
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Adenomyosis-Case Group
The study will include those diagnosed with adenomyosis who were evaluated by gynecological examination and ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic, aged 18-45 reproductive period, pregnancy status excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use.
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Healthy patients-Control
The study will include those who have been gynecologically examined and evaluated with ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic, aged 18-45 reproductive period, pregnancy status excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use, without adenomyosis diagnosis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of Adenomyosis
Time Frame: 2 months
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MUSA Criteria
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2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of Adenomyosis-Cervical Elastography
Time Frame: 4 months
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Cervical Elastography
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4 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AESH-EK1-2023-630
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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