Abstract
Background: Randomized controlled trials (RCTs) addressing varicocele treatment are scarce and have conflicting outcomes.
Objective: To determine whether varicocele treatment is superior or inferior to no treatment in male infertility from an evidence-based perspective.
Design, setting, and participants: A prospective, nonmasked, parallel-group RCT with a one-to-one concealed-to-random allocation was conducted at the authors' institution from February 2006 to October 2009. Married men 20-39 yr of age who had experience infertility >= 1 yr, had palpable varicoceles, and with at least one impaired semen parameter (sperm concentration <20 million/ml, progressive motility <50%, or normal morphology <30%) were eligible. Exclusions included subclinical or recurrent varicoceles, normal semen parameters, and azoospermia. Sample size analysis suggested 68 participants per arm.
Intervention: Participants were randomly allocated to observation (the control arm [CA]) or subinguinal microsurgical varicocelectomy (the treatment arm [TA]). Semen analyses were obtained at baseline (three analyses) and at follow-up months 3, 6, 9, and 12. The mean of each sperm parameter at baseline and follow-ups was determined.
Measurements: We measured the spontaneous pregnancy rate (the primary outcome), changes from baseline in mean semen parameters, and the occurrence of adverse events (AE-the secondary outcomes) during 12-mo follow-up; p < 0.05 was considered significant.
Results and limitations: Analysis included 145 participants (CA: n = 72; TA: n = 73), with a mean age plus or minus standard deviation of 29.3 +/- 5.7 in the CA and 28.4 +/- 5.7 in the TA (p = 0.34). Baseline characteristics in both arms were comparable. Spontaneous pregnancy was achieved in 13.9% (CA) versus 32.9% (TA), with an odds ratio (OR) of 3.04 (95% confidence interval [CI], 1.33-6.95) and a number needed to treat (NNT) of 5.27 patients (95% CI, 1.55-8.99). In CA within-arm analysis, none of semen parameters revealed significant changes from baseline (sperm concentration [p = 0.18], progressive motility [p = 0.29], and normal morphology [p = 0.05]). Conversely, in TA within-arm analysis, the mean of all semen parameters improved significantly in follow-up versus baseline (p < 0.0001). In between-arm analysis, all semen parameters improved significantly in the TA versus CA (p < 0.0001). No AEs were reported.
Conclusions: Our RCT provided level 1b evidence of the superiority of varicocelectomy over observation in infertile men with palpable varicoceles and impaired semen quality, with increased odds of spontaneous pregnancy and improvements in semen characteristics within 1-yr of follow-up. (C) 2010 European Association of Urology. Published by Elsevier B. V. All rights reserved.