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

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Full Text

Duke Authors

Cited Authors

  • Kerin, JF; Cooper, JM; Price, T; Herendael, BJV; Cayuela-Font, E; Cher, D; Carignan, CS

Published Date

  • June 2003

Published In

Volume / Issue

  • 18 / 6

Start / End Page

  • 1223 - 1230

PubMed ID

  • 12773450

International Standard Serial Number (ISSN)

  • 0268-1161

Digital Object Identifier (DOI)

  • 10.1093/humrep/deg256


  • eng

Conference Location

  • England