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

NCT06697444 | Completed

• 1 other identifier: IR.IAU.MSHD.REC.1399.061
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenomyosis; Endometriosis; Leiomyoma (Uterine Fibroids); Ovarian Cysts

Keywords

Adenomyosis; magnetic resonance imaging; risk factors

Outcome Measures

Primary Outcomes (1)

• Prevalence of Endometriosis in Participants Diagnosed with MRI-Confirmed Adenomyosis

  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

Eligibility Criteria

• Age: Up to 50 Years
• Gender Eligibility Details: Only individuals who self-identify as female were eligible to participate in this study, as it focused on conditions specific to the uterus.
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad Medical Sciences, Islamic Azad University

Mashhad, Iran

Location

MeSH Terms

Conditions

Adenomyosis; Endometriosis; Leiomyoma; Ovarian Cysts

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

IR (1)