Evaluation of the effect of vitamin D supplementation on spermatogram, seminal and serum levels of oxidative stress indices in asthenospermia infertile men: a study protocol for a triple-blind, randomized controlled trial

Abstract

Abstract Background It is suggested that vitamin D may have a beneficial role in male reproduction. The male reproductive system is a target tissue for vitamin D. This study will aim to evaluate the effects of vitamin D supplementation on sperm parameters, seminal and serum levels of oxidative stress and serum endocrine factors in asthenospermia infertile men. Methods/design This randomized, triple-blind, placebo-controlled clinical trial will be conducted on 86 infertile men with idiopathic asthenozoospermia (the mobility of sperm < 40% and rapid progressive sperm motility < 32%), with serum levels of vitamin D less than 30 ng / ml in the “Infertility Clinic of Ahvaz Jahad daneshgahi”, Iran. Main outcomes measure (s) Demographic data, dietary intake, physical activity, sun exposure, anthropometric indices, serum and seminal levels of MDA (Malondialdehyde), 8-hydroxy-2- Dioxy Guanosine (8-OHDG), Total Antioxidant Capacity (TAC) and calcium, sperm DNA fragmentation index (DFI), serum 25-OHD, luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone (T), estradiol (E2), sex hormone-binding globulin (SHBG), free androgen index (FAI = T/SHBG. 100), T/LH and T/E2 ratios, prolactin (PRO), parathyroid hormone (PTH), osteocalcin (OCN), phosphorus and sperm parameters. Discussion The deficiency of vitamin D as an antioxidant is common all over the world. Numerous observational studies have shown a positive association between vitamin D levels and semen quality. However, few clinical studies have been conducted in this area. So considering with the high prevalence of this antioxidant deficiency specifically in infertile men, it seems that the supplementation of vitamin D in infertile men with insufficient levels or deficiency may improve the status of oxidative stress and thereby may affect sperm parameters and endocrine factors involved in male fertility. Trial registration Iran Clinical Trials Registry, ID: IRCT20151128025274N4, registered on 28 March 2018.