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Objective: To describe pregnancy outcomes in women who conceived after undergoing transcervical fibroid ablation (TFA) as treatment for symptomatic uterine fibroids. Materials and Methods: TFA was used to treat symptomatic uterine fibroids with radiofrequency energy, both under clinical trial protocol and commercial usage in hospitals in Europe, the United Kingdom, Mexico, and the United States. All women who reported pregnancies to their physicians after undergoing TFA with the Sonata® System and provided consent for use of their data were included. Results: There have been 36 pregnancies representing 20 deliveries among 28 women who were treated with TFA. Five women conceived more than once postablation, and four conceived as a result of assisted reproductive technology (ART). Outcomes include 8 vaginal deliveries, 12 Cesarean sections, 3 therapeutic abortions, and 8 first trimester spontaneous abortions (four occurring in a patient with a history of recurrent pregnancy loss and an immunologic disorder). Five women are currently pregnant, two of whom previously delivered after TFA. There were no 5-minute Apgar scores <7, and all neonates weighed >2500 g. All deliveries occurred at ≥37 weeks except for one delivery at 35 6/7 weeks. There were no uterine ruptures or abnormal placentation and no reports of postpartum hemorrhage or stillbirths. Ablated fibroids included transmural, submucous, and intramural myomata up to 7 cm in diameter. Conclusions: Normal pregnancy outcomes at term have occurred after TFA with the Sonata System, including in women with recurrent abortion and in those undergoing ART. There were no instances of low Apgar scores, low birthweight, stillbirth, postpartum hemorrhage, or uterine rupture (FAST-EU, NCT01226290; SONATA, NCT02228174; SAGE, NCT03 118037). (J GYNECOL SURG 38:207).
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Background: Transcervical radiofrequency (RF) ablation of uterine fibroids is an incisionless procedure to treat nonpedunculated uterine fibroids, including those that are not amenable to operative hysteroscopy. However, its safety and effectiveness regarding fertility and fecundity have not been established, including among women with infertility. Case: A 38-year-old nullipara with infertility since 2008 and a recent complaint of refractory dysmenorrhea in association with a uterine fibroid underwent transcervical RF ablation with the Sonata® System (Gynesonics, Redwood City, CA) to treat the symptomatic myoma. Unsuccessful assisted reproduction (intracytoplasmic sperm injection/embryo transfer) as confirmed by negative pregnancy testing had been attempted 1 month preablation, and a second embryo transfer after thawing the previously cryopreserved pronuclei was performed 7 months postablation. Results: RF ablation with the Sonata System resulted in a 68% reduction in fibroid volume noted on sonography 2 months post-treatment along with resolution of the patient's dysmenorrhea. No residual fibroid was noted on sonography 7 months postablation. A second attempt at assisted reproduction produced an uncomplicated pregnancy that resulted in vacuum-assisted vaginal delivery of a liveborn infant at term weighing 3670 g with Apgar scores of 91/105/1010. Pelvic sonography 4 months postpartum an unremarkable uterus, again, with no evidence of a fibroid remnant. Conclusions: This is the first report of a pregnancy and delivery in an infertile couple who underwent transcervical RF ablation of a uterine fibroid followed by assisted reproduction.
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OBJECTIVE: To examine the role and benefits of transcervical fibroid ablation (TFA) in the treatment of submucous and large uterine fibroids. METHODS: A subgroup of patients with submucous or large fibroids were analyzed from two prospective clinical trials (FAST-EU and SONATA) of sonography-guided TFA with the Sonata® system. Key outcomes were changes in menstrual blood loss, symptom severity and health-related quality of life on the Uterine Fibroid Symptom and Quality-of-Life Questionnaire, health-related quality of life on the EQ-5D questionnaire, and surgical reinterventions for heavy menstrual bleeding. RESULTS: Among 197 women (534 treated fibroids), 86% of women with only submucous fibroids and 81% of women with large fibroids (>5 cm) experienced bleeding reduction within 3 months post-ablation. Overall symptom severity and health-related quality of life showed sustained, significant improvements over 12 months. Additional fibroid mapping of large fibroids with magnetic resonance imaging in the FAST-EU trial showed an average volume reduction of 68%. Among women with only submucous fibroids, the rate of surgical reintervention through 1 year of follow up was 3.7% in FAST-EU and 0.0% in SONATA. CONCLUSION: With the Sonata system, TFA is an effective single-stage treatment option for non-pedunculated submucous myomata, and larger or deeper uterine fibroids (including fibroid clusters) for which hysteroscopic treatment is not suitable. ClinicalTrials.gov: FAST-EU, NCT01226290; SONATA, NCT02228174.