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

Completed

• Conditions: Adenomyosis; Endometriosis; Leiomyoma (Uterine Fibroids); Ovarian Cysts

• Registration Number: NCT06697444
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-17
• Last Update Submitted: 2024-11-17
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Endometriosis in Participants Diagnosed with MRI-Confirmed Adenomyosis	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.

Trial Locations

Locations (1)

Mashhad Medical Sciences, Islamic Azad University; 🇮🇷 Mashhad, Iran, Islamic Republic of