Objective: A recent Cochrane meta-analysis of randomised clinical trials (RCTs) concluded that surgical or radiological treatment of varicocele in men from couples with otherwise unexplained subfertility cannot be recommended. The aim of the present study is to address criticisms of this review carrying out a critical analysis of all available RCTs.
Materials and methods: The eight randomised clinical trials selected in the last Cochrane Library systematic review have been evaluated. All RCTs including patients either with normal semen analysis or subclinical varicocele have been excluded. Inclusion criteria, number and clinical characteristics of randomised patients, and outcomes reported in terms of pregnancy rate one year after randomisation have been described in the remaining studies.
Results: Only 3/8 RCTs included patients with abnormal semen analysis and palpable varicocele. Overall 120 patients in the treatment group and 117 in the control group were randomised. The studies turned out to be heterogeneous in terms of inclusion criteria and clinical characteristics of the analysed patients. Their methodological quality and statistical power have to be considered poor. Moreover, the "as treated" cumulative analysis showed a significant increase in pregnancy rate in patients who underwent varicocele treatment (36.4%) compared with the control group (20%) (p = 0.009).
Conclusions: The RCTs included in the last Cochrane review concerning the efficacy of varicocele treatment in subfertile couples were heterogeneous and methodologically poor. The pooling of these studies cannot result in a good quality meta-analysis. The Cochrane meta-analysis conclusions should not support guidelines recommendation against varicocele treatment in subfertile patients. Data from ongoing studies should provide more information in this topic.