Use of essure micro-insert for treatment of hydrosalpinx prior to in vitro fertilization: a multicenter IDE/IRB off-label study

Abstract

OBJECTIVE: To evaluate the proximal tubal occlusion rate following placement of Essure inserts in women with hydrosalpinx (HS) prior to undergoing in vitro fertilization (IVF), and to observe pregnancy and delivery rates post-IVF. DESIGN: Prospective, off-label, multicenter, sequential, non-randomized, IDE and IRB approved observational study of Essure proximal tubal occlusion in women with HS and subsequent pregnancy rates following IVF using a fresh or frozen embryo (FET) cycle(s) at two fertility centers. MATERIALS AND METHODS: Twenty women identified with a unilateral or bilateral HS were offered an off-label hysteroscopic placement of Essure micro-insert(s) rather than incisional surgery for proximal tubal occlusion. All patients had follow-up HSG done 3 months post Essure placement, then IVF cycle(s). Patient ages averaged 34.1 years. Day #3 serum FSH levels averaged 6.6 mIU. Average antral count was 17. Nine women had paracervical block anesthesia, and 11 women had I.V. sedation for their placements. RESULTS: Unilateral micro-inserts were placed in 8 women with a unilateral HS, and 12 women had bilateral placement. All microinserts were intentionally placed with a reduced number of coils visible in the uterus (average of 2.6). Follow-up HSG procedures have been completed in all patients, with 19 women demonstrating proximal tubal occlusion and one patient with only one of two tubes occluded at HSG. Average number of embryos placed was 1.7. Eight women became pregnant following fresh IVF cycles, and 3 pregnancies resulted from FET cycles. Five women have not yet begun IVF. CONCLUSION: A total of 19 post-Essure IVF cycles were completed with 11 clinical pregnancies. Four women have already delivered and there are 7 ongoing pregnancies. There were 6 cycles with negative pregnancy tests. No serious adverse events occurred in any patient. Successful tubal occlusion rate was 96.9%, clinical pregnancy rate was 63.2%, and ongoing/delivered pregnancy rate is 58%.