I-49: Safely Extending Focused Ultrasound Surgery for Uterine Leiomyomas to Women Who Desire Future Pregnancies

Background: Focused ultrasound surgery (FUS) is a novel noninvasive surgery that results in localized tissue necrosis without any breech of the skin or other body orifice. MRI guidance provides anatomic visualization and real time thermal feedback. Our goal is to safely extend this therapy to women who desire future pregnancies. Materials and Methods: We have undertaken 4 multisite trials of FUS treatment and are currently conducting two randomized clinical trials (RCTs) comparing FUS to other therapies (NCT00730886 and NCT00995878, clinicaltrials. gov). Because of the novel nature of the therapy, for initial clinical trials we excluded women desiring fertility to avoid possible harm. However, we tracked women who reported subsequent pregnancy. Results: We have pioneered FUS therapy to achieve a FDA and CE-approved therapy for symptomatic uterine fibroids. We have also reported on a cohort of women who have achieved pregnancies following FUS therapy. In this cohort, women had a mean age at treatment of 37.2 + 4.6 years and 39% were at least 40 years old at the time of treatment. Mean time to conception was 8 months. Thirty-eight percent of these women had never been pregnant and 58 % had never had a delivery. Live births occurred in 41% of pregnancies and an additional 20% of women had an ongoing pregnancy beyond 20 weeks at the time of report. The spontaneous and elective abortion rates were 28% sand 11%, respectively. Sixty-four percent of women had a vaginal delivery and the mean birth weight was 3.3 kgs. There were no low birth weight infants and no pattern of maternal or neonatal complications. We are currently preparing a report on a RCT of FUS vs. myomectomy for couples with unexplained infertility, distortion of the endometrial cavity and non-hysteroscopically resectable fibroids (NCT00730886) and conducting a RCT of FUS and uterine artery embolization (UAE). Conclusion: FUS is a novel noninvasive therapy for uterine fibroids. Despite the fact that fibroids are associated with higher complication rates during pregnancy, labor and delivery and an increased risk of cesarean delivery, presumably by interfering with uterine contractility pregnancy outcomes following FUS therapy are promising. Mean time to pregnancy is similar to case series of UAE treatment, with increased delivery rates and lower cesarean section rates. This work is or has been supported by clinical trial agreements with InSightec Inc (Dallas TX USA and Haifa, Israel) and grants RC1 063312 and R01 060503 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health, (Bethesda, MD, USA).