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 eitherIVF, 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.
RCT Entities:
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.
Authors: James F Smith; Michael L Eisenberg; Susan G Millstein; Robert D Nachtigall; Natalia Sadetsky; Marcelle I Cedars; Patricia P Katz Journal: Fertil Steril Date: 2010-07-25 Impact factor: 7.329
Authors: Rui Wang; Nora A Danhof; Raissa I Tjon-Kon-Fat; Marinus Jc Eijkemans; Patrick Mm Bossuyt; Monique H Mochtar; Fulco van der Veen; Siladitya Bhattacharya; Ben Willem J Mol; Madelon van Wely Journal: Cochrane Database Syst Rev Date: 2019-09-05
Authors: D Milardi; G Grande; D Sacchini; A L Astorri; G Pompa; A Giampietro; L De Marinis; A Pontecorvi; A G Spagnolo; R Marana Journal: Int J Endocrinol Date: 2012-01-26 Impact factor: 3.257
Authors: R van Eekelen; N van Geloven; M van Wely; S Bhattacharya; F van der Veen; M J Eijkemans; D J McLernon Journal: Hum Reprod Date: 2019-07-08 Impact factor: 6.353