Hum. Reprod. Advance Access originally published online on March 25, 2004
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Human Reproduction, Vol. 19, No. 5, 1105-1109,
May 2004
© 2004 European Society of Human Reproduction and Embryology
A multicentre randomized controlled trial of expectant management versus IVF in women with Fallopian tube patency
1 Department of Obstetrics and Gynecology, and 6 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, 2 Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, 3 Department of Obstetrics and Gynecology, University of Western Ontario, London, 4 Department of Obstetrics and Gynecology, University of Toronto, Toronto, Ontario and 5 Genesis Fertility Centre Incorporated, Vancouver, British Columbia, Canada
7 To whom correspondence should be addressed at: Department of Obstetrics and Gynecology, McMaster University Medical Centre, 1200 Main Street West, Room 4D14, Hamilton, ON L8N 3Z5, Canada. Email: hughese{at}mcmaster.ca
BACKGROUND: Although observational studies suggest that IVF is more effective than no treatment for women with Fallopian tube patency, this has not been tested rigorously in a randomized controlled trial (RCT). METHODS: Eligible consenting couples planning their first treatment cycle in five Canadian fertility clinics received either IVF, within 90 days of randomization, or a period of 90 days with no treatment. Random allocation was stratified by female age and sperm quality, and administered using numbered, opaque, sealed envelopes. Follow-up assessed live birth and associated morbidity. RESULTS: Sixty-eight couples were randomized to a first cycle of IVF and 71 couples had 3 months without treatment. The live birth rates were 20/68 (29%) and 1/71 (1%), respectively. The single delivery in the untreated group was of twins, as were six of the 20 IVF deliveries (30%). An average of 2.0 embryos were transferred and no triplet pregnancies resulted. The relative likelihood of delivery after allocation to IVF was 20.9-fold higher than after allocation to no treatment [95% confidence interval (CI) 2.8–155]. The presence of abnormal sperm did not reduce this likelihood. Treating four women (95% CI 3–6) with one cycle of IVF is required to achieve a single additional birth. CONCLUSIONS: This study provides a valid and up-to-date comparison for policy makers and patients as they make choices around IVF, accurately measuring and confirming a major benefit from treatment.
Key words: effectiveness/IVF/treatment-independent pregnancy
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