title: Effectiveness of combined tamoxifen citrate and testosterone undecanoate treatment in men with idiopathic oligozoospermia.
abstract: 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.
  
  
  METHODS
  Prospective, randomized, placebo-controlled trial.
  
  
  METHODS
  Clinical research in a tertiary care academic hospital.
  
  
  METHODS
  Two hundred twelve men with idiopathic oligozoospermia and 82 normozoospermic men with female factor subfertility.
  
  
  METHODS
  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.
  
  
  METHODS
  Pregnancy incidence and sperm characteristics after 3 and 6 months on medication and 3 months after the end of the trial.
  
  
  RESULTS
  In the active treatment group, total sperm count (median [25th, 75th percentile], 27.1 x 10(6) 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).
  
  
  CONCLUSIONS
  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 oligozoospermia.
authors.affiliation: Department of Endocrinology, Elena Venizelou Hospital, Athens, Greece. hel-soc-andro@ath.fortnet.gr
authors.forename: Dimitrios A
authors.initials: DA
authors.lastname: Adamopoulos
authors.forename: Athina
authors.initials: A
authors.lastname: Pappa
authors.forename: Evangelia
authors.initials: E
authors.lastname: Billa
authors.forename: Stamatina
authors.initials: S
authors.lastname: Nicopoulou
authors.forename: Eftychia
authors.initials: E
authors.lastname: Koukkou
authors.forename: John
authors.initials: J
authors.lastname: Michopoulos
mesh_terms: D000328:Adult; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009845:Oligospermia / Q000188:drug therapy*; D010919:Placebos; D011247:Pregnancy; D018873:Pregnancy Rate; D012306:Risk; D013076:Sperm Count; D013081:Sperm Motility / Q000187:drug effects; D013094:Spermatozoa / Q000187:drug effects / Q000502:physiology / Q000648:ultrastructure; D013629:Tamoxifen / Q000627:therapeutic use*; D013739:Testosterone / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D045165:Testosterone Congeners / Q000627:therapeutic use*
chemical_list: D010919:Placebos; D045165:Testosterone Congeners; D013629:Tamoxifen; D013739:Testosterone; C010792:testosterone undecanoate