Effect of Ceratonia siliqua (Carob) syrup and vitamin E on sperm parameters, oxidative stress index and sex hormones in infertile men: Protocol for a randomized controlled trial

BACKGROUND: Spermatogenesis is a necessary process in fertility and reproductive capacity of humans. In view of the relative high prevalence of spermatogenesis disorders in men and the failure of treatments provided in conventional medicine, new therapeutic approaches are being considered. This study will be designed to investigate the effect of Ceratonia siliqua (Carob) syrup and vitamin E on sperm parameters, oxidative stress index and reproductive hormones in infertile men. METHODS: This randomized controlled trial protocol will be set in Babol Uuniversity of Medical Sciences. The proposed sample size is 60 men with oligozoospermia and teratospermia with 30 men in the experimental group taking Carob syrup while 30 men in the comparison group receiving vitamin E. The primary outcome measure is the change in semen parameters and secondary outcome measures including change in endocrine parameters and stress oxidative markers. This research was registered in the website of Iranian Registry of Clinical Trials as IRCT20171209037794N1identification number CONCLUSION: If the beneficial effect of this herb can be confirmed, it will provide a cost-effective method for helping infertile men and provide evidence-based references for the treatment of male infertility in future.