Essure Multicenter Off-Label Treatment for Hydrosalpinx Before In Vitro Fertilization

Abstract

Study Objective To estimate the safety and efficacy of Essure placement for proximal tubal occlusion in women with hydrosalpinx before in vitro fertilization (IVF). Design Prospective 2-center clinical study of women with hydrosalpinx who were recruited for off-label unilateral or bilateral placement of Essure before IVF (Canadian Task Force classification II-2). Setting Tertiary office-based infertility and IVF practice settings. Patients Twenty women with bilateral or unilateral hydrosalpinx desiring IVF. Interventions Office-based Essure placement and subsequent hysterosalpingography confirmation of proximal tubal occlusion. Measurements and Main Results Placement success, and proximal tubal occlusion and birth rate after IVF. Eight women with unilateral hydrosalpinx received unilateral Essure placement, and 12 women with bilateral hydrosalpinx received bilateral placement. One unsuccessful placement occurred. Hysterosalpingography confirmed proximal tubal occlusion in 19 of 20 women (95%) and of 31 of 32 tubes (97%) with Essure placement. Subsequent IVF resulted in 12 live births, for a birth rate per transfer of 57% (12 of 21) and a birth rate per patient of 67% (12 of 20). Four obstetric complications were reported including placenta previa, hypertension, maternal diabetes with premature rupture of membranes, and preeclampsia. All infants are well. Conclusion Placement of Essure microinserts is an effective method of nonincisional proximal tubal occlusion of hydrosalpinx. Success rates achieved through subsequent IVF are typical of outcomes of good-prognosis in similarly aged patients without hydrosalpinx in our same programs, based on 2008 Society for Assisted Reproductive Technologies data.