Comparing focused ultrasound and uterine artery embolization for uterine fibroids-rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial

Objective: To present the rationale, design, and methodology of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) study. Design: Randomized clinical trial. Setting: Two academic medical centers. Patient(s): Premenopausal women with symptomatic uterine fibroids. Intervention(s): Participants are randomized to two U. S. Food and Drug Administration-approved minimally invasive treatments for uterine leiomyomas: uterine artery embolization and magnetic resonance-guided focused ultrasound. Main Outcome Measure(s): The primary endpoint is defined as the need for an additional intervention for fibroid symptoms following treatment. Secondary outcomes consist of group differences in symptom alleviation, recovery trajectory, health-related quality of life, impairment of ovarian reserve, treatment complications, and the economic impact of these issues. Result(s): The trial is currently in the phase of active recruitment. Conclusion(s): This randomized clinical trial will provide important evidence-based information for patients and health care providers regarding optimal minimally invasive treatment approach for women with symptomatic uterine leiomyomas. Clinical Trial Registration: NCT00995878. (Fertil Steril (R) 2011;96:704-10. (C)2011 by American Society for Reproductive Medicine.)