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Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study
John F Kerin1, Jay M Cooper, Thomas Price
1Reproductive Medicine Unit, University of Adelaide, Ashford Hospital, South Australia, Australia. kerinjf@senet.com.au
Human Reproduction (Oxford, England)
|May 30, 2003
Summary
Hysteroscopic sterilization using micro-inserts offers effective permanent contraception with high patient satisfaction and rapid recovery. This minimally invasive sterilization method avoids surgical incisions and ensures excellent long-term tolerability and efficacy.
Area of Science:
- Reproductive medicine
- Minimally invasive gynecologic surgery
Background:
- Hysteroscopic sterilization provides an alternative to laparoscopic surgery, avoiding incisions and requiring only local anesthesia or sedation.
- The safety, tolerability, and efficacy of a hysteroscopically placed micro-insert device were assessed.
Purpose of the Study:
- To evaluate the safety, tolerability, and efficacy of hysteroscopic sterilization using a micro-insert device for permanent contraception.
Main Methods:
- A prospective international multicenter trial involved 227 previously fertile women.
- Micro-inserts were placed bilaterally into the proximal Fallopian tubes under hysteroscopic visualization in an outpatient setting.
Main Results:
- Successful bilateral micro-insert placement was achieved in 88% of women, with 90% rating tolerance as good to excellent.
- No pregnancies were recorded after 6015 woman-months of follow-up, and 98% reported excellent long-term tolerance.
- Adverse events occurred in 7% of women, with none being serious, and correct placement was confirmed in 97% at 3 months.
Conclusions:
- Hysteroscopic sterilization offers rapid patient recovery with minimal post-procedure pain.
- The procedure demonstrates high long-term patient tolerability, satisfaction, and effective permanent contraception.