Clinical trial NCT06697444: Risk Factors and Disorders Linked to Uterine Adenomyosis on MRI in Reproductive-Age Women
Official title: Risk Factors and Disorders Associated With Uterine Adenomyosis Diagnosed on Magnetic Resonance Imaging in Women of Reproductive Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenomyosis
Endometriosis
Leiomyoma (Uterine Fibroids)
Ovarian Cysts
Keywords: Adenomyosis
magnetic resonance imaging
risk factors
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 50
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Endometriosis in Participants Diagnosed with MRI-Confirmed Adenomyosis
timeFrame: From admission to discharge, up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad Medical Sciences, Islamic Azad University
Study officials:
References: