INEFFECTIVENESS OF KALLIKREIN IN TREATMENT OF IDIOPATHIC MALE-INFERTILITY - A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

In order to clarify the potential of kallikrein for treatment of idiopathic male infertility, a double-blind, randomized, placebo-controlled study was performed. A total of 44 patients were treated with 600 IU/day kallikrein and 47 patients with placebo for 12 weeks. Following two basal investigations, control examinations were performed at 6 and 12 weeks and included conventional and computer-aided semen analysis, hormone measurements and evaluation of drug safety. No significant changes in sperm concentration, normal sperm morphology and sperm motility evaluated by conventional analysis were detected. Computer-aided semen analysis revealed a significant increase in average path velocity and lateral head displacement of spermatozoa only in the placebo group. Within the observation period of 6 months four pregnancies occurred in each group. In conclusion, kallikrein treatment at a dose of 600 IU/day leads neither to an improvement of semen variables nor does it increase the pregnancy rate of the female partners, and is therefore not suited for therapy of idiopathic male infertility.