An interventional study of MRI-HIFU in Uterine Fibroids and Adenomyosis, sponsored by Turku University Hospital. Recruiting at 1 site in Finland. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-29.
Sponsored by Turku University Hospital · Not applicable, Interventional, and Treatment
MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this study is to obtain more information on the systemic response of the body to the HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the UFS-QoL questionnaire.
Also new methods for improving patient selection as well as treatment efficacy will be evaluated in this study.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's planned enrollment of 500 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.
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Exclusion criteria
Device: MRI-HIFU
Treatment of uterine fibroids with MRI-HIFU
Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
Time frame: 12 months after treatment
Plan to share: Undecided
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Turku University Hospital