Effectiveness of combined tamoxifen citrate and testosterone undecanoate treatment in men with idiopathic oligozoospermia

Objective: To assess the effect of treatment with a combination of the antiestrogen tamoxifen citrate and the androgen testosterone undecanoate on sperm variables and pregnancy incidence in men with idiopathic oligozoospermia and couple subfertility. Design: Prospective, randomized, placebo-controlled trial. Setting: Clinical research in a tertiary care academic hospital. Participant(s): Two hundred twelve men with idiopathic oligozoospermia and 82 normozoospermic men with female factor subfertility. Intervention(s): Oligozoospermic patients were randomly assigned to two treatment groups with tamoxifen citrate, 20 mg/d, and testosterone undecanoate, 120 mg/d (n = 106) or placebo treatment (n = 106) for 6 months. Normozoospermic men were followed for the same period. Couple counseling was part of the intervention in all groups. Main Outcome Measure(s): Pregnancy incidence and sperm characteristics after 3 and 6 months on medication and 3 months after the end of the trial. Result(s): In the active treatment group, total sperm count (median [25th, 75th percentile], 27.1 x 106 cells/mL [9.4, 54.0 x 10(6) cells/mL] at baseline and 61.5 X 10(6) cells/mL [28.2, 119.6 x 10(6) cells/mL] at 6 months), progressive motility (mean [+/-SD], 29.7% +/- 12.0% at baseline and 41.6% +/- 13.1% at 6 months), and normal morphology (mean, 41.2% +/- 14.0% at baseline and 56.6% +/- 11.5% at 6 months) were noted. No marked changes were observed in placebo recipients or normozoospermic men. The incidence of spontaneous pregnancy was 33.9% in the active treatment group and 10.3% in the placebo group (36 vs. 11 pregnancies), with a relative risk of 3.195 (95% CI, 2.615 to 3.765). Conclusion(s): Treatment with tamoxifen citrate and testosterone undecanoate improved sperm variables and led to a higher incidence of pregnancy in couples with subfertility related to idiopathic oligorzoospermia. (C)2003 by American Society for Reproductive Medicine.