EFFICACY OF KALLIKREIN IN THE TREATMENT OF OLIGOZOOSPERMIA AND ASTHENOZOOSPERMIA - A DOUBLE-BLIND TRIAL

Objective: To assess the effect of kallikrein on sperm motility and sp erm count in infertile oligozoospermic and asthenozoospermic men. Desi gn: Double-blind placebo-controlled clinical trial. Setting: Multicent er trial in three andrologic clinics. Patients: Infertile men with <20 X 10(6) total sperm count and >3 X 10(6) sperm cells/mL and/or sperm motility of <30%. Interventions: One hundred fourteen men received eit her placebo or 600 kallikrein units of kallidinogenase by mouth daily for 12 weeks. Semen analyses were performed before and at 6-week inter vals during the trial. Compliance and incidence of adverse effects wer e assessed. Results: The incidence of adverse effects was similar unde r placebo and under kallidinogenase treatment, usually mild, transient , and did not require the cessation of treatment in any patient. Kalli dinogenase was not superior to placebo in improving sperm count and sp erm motility. Conclusions: At the doses and for the duration given, ou r results were disappointing. The absence of a therapeutical effect, a s evidenced in the present study may be due to the very low absorption rate of kallidinogenase after oral administration. Probably a much hi gher dose of kallidinogenase should be used to achieve a therapeutic a ffect.