Infertility treatment: from cookery to science. The epidemiology of randomised controlled trials

British Journal of Obstetrics and Gynaecology
P VandekerckhoveT W Harada


To review the epidemiology of published randomised controlled trials in infertility treatment over the last 25 years, with special emphasis on the number and quality of trials. Computer literature review by MEDLINE backed up by a manual search of 41 journals. Each trial was classified according to the methodology described and quality criteria. The results were recorded in a computer database. Odds ratios (OR) and confidence intervals (CI) were calculated where the data were sufficient. Couples suffering from primary or secondary infertility. The trials studied 33,761 patients overall. Institute of Epidemiology and Health Services Research, Leeds. Five hundred and one randomised trials in male and female infertility treatment were identified between 1966 and 1990. Pregnancy was an outcome in 291 (58%) and these were the subject of detailed analysis. Two hundred and twenty-four (77%) and 67 (23%) 'pregnancy trials' were concerned, respectively, with female and male infertility. Four per cent of the trials were preceded by a sample size calculation, and the average sample size was 96 patients (range 5-933); 700 patients per group would be required to demonstrate plausible success rates for most treatments. The method of randomisa...Continue Reading


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