Review Treatment of Varicocele in Subfertile Men: The Cochrane Review – A Contrary Opinion Vincenzo Ficarra *, Maria Angela Cerruto, Giovanni Liguori, Guglielmo Mazzoni, Sergio Minucci, Angelo Tracia, Vincenzo Gentile Italian Varicocele Study Group of the Italian Society of Andrology (SIA), Italy european urology 49 (2006) 258–263 available at www.sciencedirect.com journal homepage: www.europeanurology.com Article info Article history: Accepted November 30, 2005 Published online ahead of print on January 4, 2006 Keywords: Varicocele Subfertile men Systematic revision Abstract 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 subclini- cal varicocele have been excluded. Inclusion criteria, number and clin- ical 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’’ cumula- tive 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 hetero- geneous 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. # 2005 Elsevier B.V. All rights reserved. * Corresponding author. Cattedra e Divisione Clinicizzata di Urologia, Universita ` degli Studi di Verona, P.le L Scuro 10, 37134 - Verona, Italy. Tel. +39 045 8074370; Fax: +39 045 8074080. E-mail address: vincenzoficarra@hotmail.com, vincenzo.ficarra@univr.it (V. Ficarra). 0302-2838/$ – see front matter # 2005 Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2005.11.023