EMORY-ADVENTIST ENROLLING UTERINE FIBROID PATIENTS IN FERTILITY ENHANCEMENT STUDY
Emory-Adventist Hospital is enrolling patients in a clinical trial to evaluate the safety and effectiveness of the non-invasive ExAblate® 2000 system utilizing MR-guided Focused Ultrasound Surgery (MRgFUS) for the enhancement of fertility.
Emory-Adventist is one of 20 U.S. and international sites that will enroll a total of 650 women with non-hysteroscopically resectable uterine fibroids who are diagnosed with unexplained infertility into the study. Half the women will undergo treatment with the ExAblate system, while the other half will have their fibroids surgically removed. "While the link between uterine fibroids and infertility isn't fully understood, many women with uterine fibroids and infertility give birth to healthy babies after having their fibroids surgically removed," said John C. Lipman, M.D., FSIR, Director of the Center for Image-Guided Medicine at Emory-Adventist Hospital in Atlanta. "The non-invasive ExAblate system precisely targets fibroid tissue without causing damage to the surrounding healthy areas, suggesting that it may be a safe approach for women with fibroids who want to preserve their fertility."
The study will measure the safety of each procedure, including pregnancy and delivery-related complications. The main efficacy goal of the trial will be to measure which procedure leads to a higher percentage of healthy live births resulting from pregnancies three to 15 months after treatment. Researchers will also examine the cost of treatment and any additional clinically required medical encounters and/or medications outside the study visits.
To date, InSightec, the developer of the ExAblate system, has reported 54 pregnancies, with 22 women delivering healthy infants at term without complications and with an average of seven and a half pounds birth weight. Fourteen women delivered vaginally and eight delivered by caesarean section. No treatment-related adverse events were reported in those earlier cases. Other sites currently enrolling patients include the Mayo Clinic in Rochester, Minnesota; Duke University Medical Center in Durham, North Carolina; Willowbend Health and Wellness in Plano, Texas; and Focused Ultrasound Northwest in Renton, Washington.
For more information on the study, please visit the trial site.