Using MRI-guided ultrasound to treat benign uterine disorders
Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
This study is testing if MRI-guided ultrasound can help women with painful uterine fibroids and adenomyosis feel better and how it might affect their fertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Turku University Hospital Government |
| Locations | 1 site (Turku) |
| Trial ID | NCT02914704 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of MRI-guided high intensity focused ultrasound (MRI-HIFU) as a treatment for symptomatic uterine fibroids and adenomyosis. It aims to gather data on the systemic response of the body to this treatment and its effects on fertility-related factors. Women who meet specific eligibility criteria will undergo MRI-HIFU, with their symptoms assessed using a quality of life questionnaire before and after treatment. Additionally, blood, urine, and endometrial samples will be collected at various intervals to analyze the treatment's impact.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women with symptomatic uterine fibroids or adenomyosis who meet specific health criteria.
Not a fit: Patients with pelvic tumors, major uterine anomalies, or those who are unable to undergo MRI due to health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for women suffering from uterine fibroids and adenomyosis, potentially improving their quality of life and fertility outcomes.
How similar studies have performed: Previous studies have shown that MRI-HIFU is a safe and effective treatment for uterine fibroids, but this specific investigation into fertility factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI \< 35 * Premenopausal * Uterine size \<20 gw * Willingness to participate to the research * Uterine fibroids with typical symptoms * Maximum of 4 treated fibroids * Dominant fibroid \>2.5cm * \>50% of the fibroid is treatable Exclusion criteria * Unspecified pelvic tumours or ovarian masses, PID * Major corrective surgery to uterus (simple myomectomy excluded) * Major uterine anomalies * Unability to calculate the volume of uterine fibroids * Marked uterine calcification * Marked scarring of the lower abdomen * Suspicion of malignancy * Marked general health problem contraindicating MRI * Claustrophobia
Where this trial is running
Turku
- Turku University Hospital — Turku, Finland (Recruiting)
Study contacts
- Principal investigator: Kirsi M Joronen, PhD — Turku University Hospital
- Study coordinator: Kirsi M Joronen, PhD
- Email: kirsi.joronen@tyks.fi
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.