title: Reversible germ cell toxicity of sulphasalazine and ampicillin combination in male rats.
abstract: BACKGROUND
  The antifertility effect of ampicillin (AMP, 40 mg/kg) and sulphasalazine or salicylazosulfapyridine (SASP, 300,450 and 600 mg/kg) in male rats has been reported earlier. The combination of AMP and SASP is generally used in certain pathological conditions, but the combined effect of these two drugs on the fertility is not clear. So, the aim of this study was to investigate the antifertility effect of ampicillin and sulphasalazine combination in male rats.
  
  
  METHODS
  In the present study, forty rats were randomly divided into five groups (n=8). Group I served as the control, while Group II and III received AMP and SASP at the doses of 20 mg/kg and 200 mg/kg respectively. Moreover, group IV and V received the combination of SASP (100 mg/kg) and AMP (10 mg/kg). However, for evaluating the reversible effect of the combination, a washout period of 30 days was given in group V. After 45 days of drug treatment, each rat was sacrificed. The testes, seminal vesicles and epididymis were dissected & weighed. Furthermore, fertility tests, sperm characteristic analysis, histopathological studies, testosterone assay and tissue biochemistry were performed. The data were analyzed using ANOVA and in case ANOVA shows statistical differences, post hoc analysis was performed.
  
  
  RESULTS
  A decrease in parameters related to fertility of males such as sperm count, sperm motility, fertility ratio, serum testosterone level, glycogen and protein content in sexual organs was observed. Although AMP and SASP significantly (p<0.001) reduced the reproductive activity separately, but their combination was found to be impairing the reproductive activity at a considerably lower dose. However, on withdrawing the treatment, all these parameters were restored which was confirmed by the histopathological analysis of the testis.
  
  
  CONCLUSIONS
  The combination produces synergistic antifertility effect in male rats and the effect was reversible. The dose and efficacy of results could be extrapolated in future clinical trials.
authors.affiliation: Department of Pharmaceutical Technology, Meerut Institute of Engineering and Technology, Uttar Pradesh, India.
authors.forename: Himanshu
authors.initials: H
authors.lastname: Gupta
authors.forename: Kamal Kishore
authors.initials: KK
authors.lastname: Maheshwari
authors.forename: Nitin
authors.initials: N
authors.lastname: Kumar
keywords: Ampicillin; Fertility; Serum testosterone assay; Sperm count; Sulphasalazine