Occlusion of the spermatic vein by surgical or angiographic techniques is generally accepted as the treatment of choice in infertile patients with varicocele. We have recently demonstrated that surgical ligation and radiological embolization are equally effective in terms of pregnancies following treatment. Since, however, it remains unclear whether any treatment is more effective than no treatment, we initiated a controlled, randomized prospective study to address this question. Infertile patients with varicocele were investigated twice using Doppler sonography, ultrasonography of the scrotal contents, semen analysis according to World Health Organization guidelines and serum follicle stimulating hormone, luteinizing hormone and testosterone measurements. Other causes of male infertility were excluded. The patients' wives were free of obvious causes of infertility such as anovulation or tubal blockage. Subjects fulfilling the admission criteria were randomly allocated to groups receiving ligation, embolization or no treatment. Thereafter, all patients were investigated and counselled every 3 months for a period of 1 year. In all, 47 couples in the treatment group (23 ligations and 24 embolizations) and 48 in the non-treatment group concluded the study. When entering the study, there were no significant differences in semen analysis and hormonal parameters between the two groups, nor between the subgroups undergoing treatment. While no significant changes in semen parameters occurred in the non-treatment group, the sperm concentration increased significantly (P = 0.008) in the treated patients from 16.5 +/- 2.5 x 10(6)/ml (mean +/- SE) before to 25.1 +/- 4.1 x 10(6)/ml at the end of the study. A total of 25 pregnancies were recorded during the 1-year study period, 12 in the treatment group (25.5 %) and 13 in the non-treatment group (27.1%). This difference was not significant. These results challenge the current standard approach of varicocele repair and emphasize the need for properly controlled studies in infertility treatment.
