Risk Factors and Disorders Linked to Uterine Adenomyosis on MRI in Reproductive-Age Women

November 17, 2024 updated by: Narges Afzali, Mashhad University of Medical Sciences

Risk Factors and Disorders Associated With Uterine Adenomyosis Diagnosed on Magnetic Resonance Imaging in Women of Reproductive Age

The goal of this observational case-control study is to identify risk factors and associated conditions related to adenomyosis in women of reproductive age.

The main questions it aims to answer are:

Is there an association between a history of uterine surgery and the occurrence of adenomyosis? Does a higher prevalence of endometriosis or increased number of pregnancies correlate with adenomyosis? Researchers will compare women with MRI-confirmed adenomyosis to a control group of women who underwent pelvic MRI for other reasons but were not diagnosed with adenomyosis to see if there are significant differences in risk factors such as endometriosis, number of pregnancies, and history of uterine surgery.

Participants will:

Undergo pelvic MRI with and without intravenous contrast Provide information on factors such as age, smoking, number of pregnancies, history of uterine surgery, and coexisting conditions like leiomyoma and ovarian cysts This study aims to inform better management strategies for reducing the incidence of adenomyosis by targeting modifiable risk factors.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Case Group: 50 women of reproductive age (18-50 years) who were diagnosed with adenomyosis based on MRI findings.

Control Group: 50 women of reproductive age (18-50 years) who underwent pelvic MRI for various clinical reasons but were not diagnosed with adenomyosis.

Description

Inclusion Criteria:

  • Women of reproductive age (18-50 years).
  • Patients who underwent pelvic MRI for clinical indications.
  • MRI-confirmed diagnosis of adenomyosis (for the case group).
  • Patients without adenomyosis confirmed by MRI (for the control group).
  • Willingness to participate and provide informed consent.

Exclusion Criteria:

  • Women outside the reproductive age range (under 18 or over 50 years).
  • Pregnancy or lactation at the time of MRI.
  • Previous hysterectomy or other major uterine surgeries.
  • Presence of malignancies or other serious conditions that could interfere with the study.
  • Inability to undergo MRI due to contraindications (e.g., metal implants, pacemakers).
  • Incomplete or missing MRI data.
  • Non-consent to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Endometriosis in Participants Diagnosed with MRI-Confirmed Adenomyosis
Time Frame: From admission to discharge, up to 1 week
he presence of endometriosis will be evaluated in participants who have been diagnosed with adenomyosis through pelvic MRI. Diagnosis will be confirmed based on established imaging criteria, including areas of low signal intensity on T2-weighted MRI images. The prevalence will be compared between the case group (women with adenomyosis) and the control group (women without adenomyosis). The outcome will be reported as the percentage of participants in each group diagnosed with endometriosis.
From admission to discharge, up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 17, 2024

First Posted (Estimated)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.IAU.MSHD.REC.1399.061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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