Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study

TLDR

Unlike laparoscopic surgery for interval tubal sterilization, a hysteroscopic approach obviates surgical incision and requires only local anaesthesia or intravenous sedation. The study evaluated the safety, tolerability and efficacy of a hysteroscopically placed micro‑insert device in 227 previously fertile women. Micro‑inserts were placed bilaterally into the proximal Fallopian tube lumens under hysteroscopic visualization during outpatient procedures, achieving successful placement in 88 % of women. The procedure was well tolerated, with 90 % of women rating pain as good to excellent, most discharged within 1–2 h, 7 % experiencing non‑serious adverse events, 97 % correct placement at 3 months, 98 % reporting very good to excellent tolerance over 24 months, and no pregnancies after 6015 woman‑months, demonstrating effective permanent contraception.

Abstract

Unlike laparoscopic surgery for interval tubal sterilization, a hysteroscopic approach obviates surgical incision and requires only local anaesthesia or intravenous sedation. The safety, tolerability and efficacy of an hysteroscopically placed micro-insert device was evaluated.A cohort of 227 previously fertile women participated in this prospective international multicentre trial. Micro-inserts were placed bilaterally into the proximal Fallopian tube lumens under hysteroscopic visualization in outpatient procedures.Successful bilateral micro-insert placement was achieved in 88% of women. The majority of women reported that intraprocedural pain was less than or equal to that expected, and 90% rated tolerance of the device placement procedure as good to excellent. Most women could be discharged in an ambulatory state within 1-2 h. Adverse events occurred in 7% of the women, but none was serious. Correct device placement was confirmed in 97% of cases at 3 months. Over 24 months follow-up, 98% of study participants rated their tolerance of the micro-insert as very good to excellent. After 6015 woman-months of exposure to intercourse, no pregnancies have been recorded.Hysteroscopic sterilization resulted in rapid patient recovery without unacceptable post-procedure pain, as well as high long-term patient tolerability, satisfaction and effective permanent contraception.