26th Annual EAU Congress: 2nd prize Best Abstract in Non-Oncology
Thursday, 7 April 2011- T. A. Abdel-Meguid and colleagues (Jeddah, Saudi Arabia) won the second prize for Best Abstract in Non-Oncology during the 26th Annual EAU Congress held recently in Vienna, Austria. Below is the winning abstract, unedited and without additional commentary:
Title: Does varicocele repair improve male infertility? An evidence-based perspective from a randomized controlled trial
Authors List: Abdel-Meguid, T.A., Al-Sayyad, A.G., Tayib, A.M.S., Farsi, H.M.A.
King Abdulaziz University Medical City, Dept. of Urology, Jeddah, Saudi Arabia
Introduction & Objectives
Background: Randomized-controlled trials (RCTs) addressing varicocele treatment are scarce with conflicting outcomes.
Objective: To determine whether varicocele treatment is superior or non-superior to no-treatment in male infertility; through an evidence-based perspective.
Material & Methods
Design and Setting: A prospective, non-masked, parallel-group, RCT with 1:1 concealed computer generated random-allocation; conducted at authors' institution between February 2006 and October 2009.
Participants: Married men, 20-39 yr old, with infertility › 1 yr, clinically palpable varicoceles, and impaired at least one semen parameter (sperm density ‹ 20X106/ml, progressive motility ‹ 50% or normal morphology ‹ 30%) were eligible. Exclusions were men with subclinical or recurrent varicoceles, normal semen parameters, azoospermia, abnormal hormonal profile, additional causes of infertility, female partner infertility, female partner › 35 yr old; or who refused randomization.
Sample size analysis prior to study commencement suggested 68 participants per arm with statistical power of 80% and alpha level at 5%.
Intervention: participants were randomly allocated to observation (control arm; CA) or subinguinal microsurgical varicocelectomy (treatment arm; TA). Semen analyses were obtained at baseline (3-analyses); and at follow-up months 3, 6, 9 and 12. Mean of each sperm parameter at baseline and follow-ups were determined.
Measurements: Spontaneous pregnancy rate (primary outcome); changes from baseline of mean of semen parameters, and occurrence of adverse effects (AEs) (Secondary outcomes) during 12-months follow-up. P ‹0.05 was significant.
Analysis included 145 participants (CA=72; TA=73) with mean ±SD age=29.3 ± 5.7 (CA), and 28.4 ±5.7 (TA) (p=0.34). Baseline demographic, clinical and semen characteristics in both arms were comparable. Spontaneous pregnancy was achieved in 13.9% (CA) vs. 32.9% (TA), with odds ratio=3.04 (95% CI=1.33-6.95) and number needed to treat to benefit (NNT) =5.27 patients.
In CA within-group analysis, none of semen parameters revealed significant changes from baseline: sperm density (p=0.77), progressive motility (p=0.88) and normal morphology (p=0.77). Conversely, in TA within-group analysis, mean of all semen parameters improved significantly in follow-up versus baseline (p ‹0.0001). In between-group analysis, all semen parameters improved significantly in TA vs. CA (p ‹0.0001). No AEs were reported.
Our RCT provided level-1b-evidence of superiority of varicocele repair over observation in infertile men with clinically palpable varicoceles and impaired semen quality; with increased odds of spontaneous pregnancy and improvements of semen characteristics within one year of follow-up.
Source: Abstract 689, Abstract Session, 26th Annual EAU Congress, Vienna, Austria, March 18-22, 2011.