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OpenTrials
Completed

NCT Number: NCT06697444

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

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.

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Key information

Who can participate

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

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 20, 2024
Registry last updated
Nov 20, 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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