Human Reproduction, Vol. 18, No. 6, 1223-1230,
June 2003
© 2003 European Society of Human Reproduction and Embryology
Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study*
1 Reproductive Medicine Unit, University of Adelaide, Ashford Hospital, Adelaide, South Australia, Australia, 2 Women’s Health Research, Phoenix, Arizona, USA, 3 Reproductive Endocrinology, Greenville, South Carolina, USA, 4 Jan Palfjin General Hospital, Merksem, Belgium, 5 Department of Obstetrics and Gynecology, Institut Universitari Parc Taulf. Hospital de Sabadell, Spain, 6 Exponent, Palo Alto, California, USA and 7 Conceptus Inc., San Carlos, California, USA
8 To whom correspondence should be addressed at: Reproductive Medicine Unit, The University of Adelaide, "Timara",154 Barton Terrace West, North Adelaide, 5006, South Australia, Australia. e-mail: kerinjf{at}senet.com.au
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.
Key words: contraceptive devices/hysteroscopic sterilization/transcervical sterilization/tubal occlusion
* These studies were funded by Conceptus, Inc., San Carlos, California, USA. John F.Kerin, Thomas Price, Charles S.Carignan and Jay M.Cooper are stockholders in Conceptus, Inc., the manufacturer of the EssureTM micro-insert. Charles S.Carignan is an employee of Conceptus, Inc. John F.Kerin, Jay M.Cooper and Thomas Price are consultants to Conceptus, Inc.
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