Iacono F, Prezioso D, Ruffo A, Di Lauro G, Illiano E, Romeo G and Romis L
Background: We investigated the efficacy of a combination therapy with tamoxifen citrate and a natural composite containing Tribulus terrestris, alga Ecklonia bicyclis and polymers of d-glucosamine and n-acetyl d-glucosamine in treating male idiopathic infertility.
Methods: In this prospective, randomized double blind, placebo-controlled study, we enrolled ninety infertile men at our department of urology at University Federico II of Naples. Mean age was 29.2 ± 7.8 [± SD]. Inclusion criteria consisted of the repeated exhibition of oligoasthenozoospermia (OA) without detectable cause (unexplained OA). Patients were randomly assigned to three treatment groups: Group A (n=30) receiving tamoxifene citrate (20 mg/day) and a natural composite with an antioxidant and androgen-mimetic action (150 mg of alga Ecklonia Bicyclis, 396 mg of Tribulus terrestris and 144 mg of polymers of d-glucosamine and n-acetyl d-glucosamine); Group B (n=30) receiving tamoxifene citrate (20 mg/day) and Group C receiving placebo (n=30). We evaluated the number of spontaneous pregnancies, sperm volume, concentration, sperm total motility, sperm forward progressive motility, normal sperm morphology.
Results: After 6 months of therapy the number of spontaneous pregnancies was markedly higher in the Group A (13 pregnancies, 33.3%) then the other two groups: Group B (6 pregnancies, 20%) and Group C (4 pregnancies, 13.3%). Sperm concentration improved in the Group A from a mean 8.49 × 106 cells/ml ± 5.57 at baseline to 22.1 × 106 cells/ml ± 1,63 (p ≤ 0.001). In the Group B there was an improvement from a mean 7.98 × 106 at baseline to 14.43 × 106 cells/ml ± 3,43 (p=0.002). Group C did not see a statistically significant improvement of sperm number, from a concentration of 9.65 × 106 cells/ml ± 6.54 to 10.53 × 106 cells/ml ± 8.5 (p=0.0025). In Group A, sperm total motility improved from 31% ± 11% at baseline to 40% ± 14% (p=0.007) whilst the forward progressive motility slightly improved from 5% ± 3% to 9% ± 4% (p=0.0034). In the group B and C, there were not reported statistically significant changes of motility.
Conclusions: The combination therapy with tamoxifen citrate and the natural compound with an andorgen-mimetic and antioxidant action leads to a higher incidence of pregnancy rates and gives a statistically significant improvement of semen parameters comparing with the single use of tamoxifen citrate and with the control group.