Does treatment of varicocele improve male fertility? results of the 'Deutsche Varikozelenstudie', a multicentre study of 14 collaborating centres.

Treatment of varicocele is suggested in infertile men if sperm parameter values are abnormal. The effectiveness of the treatment with respect to fertility remains to be clarified. A multicentre, prospective randomized study on varicocele treatment in infertile men to demonstrate the superiority of sclerotization of the varicocele in preventing persistence, was started in 1995 with the collaboration of 15 German andrological centres. The primary endpoint was the incidence of pregnancy 1 year after randomisation. The number of cases needed to achieve the goal of the study was calculated at 460. However, three years after starting the study, only 67 patients had been randomized. Different reasons contributed to the poor recruitment. There was no significant increase in pregnancy rate in the treated group, compared to the controls, the confidence interval being 20.8% to 15.7%. The authors would like to encourage further collaborative study groups to start another prospective, randomized study with the aim of avoiding the costs and risks of varicocele treatment when its success remains unclear.

RCT Entities:   Population Interventions Outcomes