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

NCT ID: NCT06697444

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-01-01

Brief Summary

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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

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Conditions

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Adenomyosis Endometriosis Leiomyoma (Uterine Fibroids) Ovarian Cysts

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Narges Afzali

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mashhad Medical Sciences, Islamic Azad University

Mashhad, , Iran

Site Status

Countries

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Iran

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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IR.IAU.MSHD.REC.1399.061

Identifier Type: -

Identifier Source: org_study_id

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