The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained infertility. Uterine fibroids are fairly common in women of child-bearing age. An evidence based review supported removing fibroids that distort the uterine cavity to increase pregnancy rates and decrease the rates of miscarriage. Some fibroids can be removed hysteroscopically which is minimally invasive, with low morbidity. However, removal of fibroids within the uterine wall require more invasive surgical procedures (e.g., myomectomy), with increasing morbidity risks including, but not limited to, infection, blood loss and postoperative uterine adhesions. ExAblate is approved by FDA for the treatment of uterine fibroids; however, its use in patients seeking pregnancy is considered experimental. Accumulated evidence suggests there are no significant complications from the procedure in women seeking pregnancy as with existing fibroid therapies; however, these data are based on a small number of patients. This study will evaluate fertility enhancement following ExAblate treatment or myomectomy, in women with unexplained infertility and who have non-hysteroscopically resectable uterine fibroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation
Invasive surgical procedure for fibroid removal
UCLA
Los Angeles, California, United States
Atlanta Interventional Institute
Smyrna, Georgia, United States
Mayo Clinic
Rochester, Minnesota, United States
Duke University
Durham, North Carolina, United States
Willowbend Health and Wellness
Plano, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Live Birth Rate
Time frame: Between the 3 and 9-month post-treatment visits
Pregnancy Rate
Time frame: Between the 3 and 15-month post-treatment visits
Term Delivery Rate
Time frame: Between the 3 and 15-month post-treatment visits
Miscarriage Rate
Time frame: Between the 3 and 15-month post-treatment visits
Time to Conception
Time frame: Post-treatment
C-Section Rate
Time frame: Post-treatment
Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
Time frame: Post-treatment
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Post-treatment
Medical Outcomes Study 36-Item Short Form Survey
Time frame: Post-treatment
Health Care Costs
Time frame: Post-treatment
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