title: A phytotherapic approach to reduce sperm DNA fragmentation in patients with male infertility.
abstract: BACKGROUND
  Infertility affects 50 to 80 million (between 8 and 12% of couples). Male factor is a cause of infertility in almost half of the cases, mainly due to oligoasthenoteratozoospermia. DNA fragmentation is now considered an important factor in the aetiology of male infertility. We studied the effects on semen analysis and on DNA fragmentation of in vivo admnistration of Myo-Inositol and Tribulus Terrestris plus Alga Ecklonia plus Biovis (Tradafertil; Tradapharma Sagl, Swizerland) in men with previously diagnosed male infertility.
  
  
  METHODS
  Sixty patients were enrolled in the present study and were randomized into two subgroups: the group A who received Myo-inositol 1000 mg, Tribulus Terrestris 300 mg, Alga Ecklonia Bicyclis 200 mg and Biovis one tablet a day for 90 days, and the group B (placebo group) who received one placebo tablet a day for 90 days. The primary efficacy outcome was the improvement of semen characteristics after 3 months' therapy and the secondary outcome was the reduction of the DNA fragmentation after treatment.
  
  
  RESULTS
  The groups were homogenous for age, hormonal levels, sperm concentration and all parameters of sperm analysis. Sperm concentration and progressive motility improved after treatment with Tradafertil (3.82 Mil/ml vs. 1.71 Mil/ml; p<0.05; 4.86% vs. 1.00%; p<0.05) as well as the DNA fragmentation (-1.64% vs -0.39%, p<0.001). No side effects were revealed.
  
  
  CONCLUSIONS
  In conclusion, we can affirm that Tradafertil is safe and tolerable. It is a new phytotherapic approach to Oligoasthenoteratospermia (OAT) syndrome that could lead to good results without interacting with hypothalamic-pituitary-gonadal axis.
authors.affiliation: Department of Urology, University Federico II of Naples, Naples - Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Capece
authors.affiliation: Department of Urology, University Federico II of Naples, Naples - Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Romeo
authors.affiliation: Department of Urology, University Federico II of Naples, Naples - Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Ruffo
authors.affiliation: Department of Urology, Hospital Santa Maria delle Grazie of Pozzuoli, Pozzuoli (Naples) - Italy.
authors.forename: Leo
authors.initials: L
authors.lastname: Romis
authors.affiliation: Department of Urology, Hospital Santa Maria delle Grazie of Pozzuoli, Pozzuoli (Naples) - Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Mordente
authors.affiliation: Department of Urology, Hospital Santa Maria delle Grazie of Pozzuoli, Pozzuoli (Naples) - Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Di Lauro
mesh_terms: D000328:Adult; D053938:DNA Fragmentation / Q000187:drug effects*; D006801:Humans; D007248:Infertility, Male / Q000188:drug therapy*; D008297:Male; D008517:Phytotherapy; D011446:Prospective Studies; D055101:Semen Analysis; D016037:Single-Blind Method