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Brief Title: ExAblate Treatment of Uterine Fibroids for Fertility Enhancement
Official Title: A Randomized Study to Evaluate the Effectiveness and Safety of ExAblate Surgery Compared With Myomectomy for the Enhancement of Fertility Following Treatment of Uterine Fibroids in Women Seeking Pregnancy
Study ID: NCT00730886
Brief Summary: 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.
Detailed Description:
Minimum Age: 21 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
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