AdenomyosisNCT06697444
Risk Factors and Disorders Linked to Uterine Adenomyosis on MRI in Reproductive-Age Women
An observational study of Adenomyosis and Endometriosis, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 50 years, women only
- Conditions the study is for
- Adenomyosis, Endometriosis, Leiomyoma (Uterine Fibroids)
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2021to 1 Jan 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- Women only
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors and Disorders Associated With Uterine Adenomyosis Diagnosed on Magnetic Resonance Imaging in Women of Reproductive Age
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:
Read more
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.
- Keywords
- Adenomyosis, magnetic resonance imaging, risk factors
- Medical subject headings
- Adenomyosis, Endometriosis, Leiomyoma, Ovarian Cysts
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From admission to discharge, up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narges Afzali, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697444
- Sponsor's protocol ID
- IR.IAU.MSHD.REC.1399.061
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Disorders Associated With Uterine Adenomyosis Diagnosed on Magnetic Resonance Imaging in Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT06697444
- Acronym / sponsor ID
- IR.IAU.MSHD.REC.1399.061
- Keywords
- Adenomyosis, magnetic resonance imaging, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis and Endometriosis, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Endometriosis in Participants Diagnosed with MRI-Confirmed Adenomyosis (time frame: From admission to discharge, up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.