IRCT2016111830947N1.

Trial name or title	The effect of oral vitamin D3 supplementation on spermogram quantitative and qualitative indicators in infertile male
Methods	Interventional (clinical trial) Design Randomisation: non‐randomised. Randomly by tossing coin. Blinding: triple‐blind Placebo: used Assignment: parallel Purpose: treatment
Participants	Males. Inclusion criteria Be healthy physically and mentally Older than 20 years and less than 45 years Body mass index is 18/5‐30 Not to intake any vitamin D3 at therapeutic doses in last 3 months Not to intake supplementation in non‐therapeutic doses in last 3 months Not to intake medications that influence on the level of vitamin D3 includes glucocorticoids and anti convulsion drugs that influence on spermatogenesis such as cimetidine Spirnolactone should not have be used according to urologist in last 3 months Lack of azoospermia in spermogram Having disrupt sperm of unknown origin(idiopatice) Lack of genital tract infection or drug treatment in this regard during the past three months according to the clinical records and according to patients saying Lack of anatomical abnormalities of the genital tract such as varicocele grade two and above Testes and vas deferens history of surgery No contact with pesticides Heavy metals and high temperature Not using cigarette or hookah in last 3 month Not using alcohol or narcotic The serum level of vitamin D3 should be less than 30 or equal to 30 Ng in litre No disorder in prolactin levels or TSH. Exclusion criteria Not taking more than one dose of vitamin D3 The existence of some signs or symptoms which prohibit the continuous of using according to urologist and nutritionist Start taking other supplements drugs that have been banned their entry criteria during the study
Interventions	Drug: the supplement of vitamin D3 (each week 1 pill of supplement vitamin D3 for 8 weeks and in remaining 4 weeks 1 supplement vitamin D3 pill as a maintenance dose) Control: placebo of vitamin D3 (each week 1 pill of Placebo vitamin D3 for 8 weeks and in remaining 4 weeks? 1 pill of Placebo vitamin D3 as a maintenance dose) Duration: 12 weeks
Outcomes	Primary: spermogram qualitative indicators Secondary: hormonal markers related to spermatogenesis(LH? FSH? TT? FT? SHBG)
Starting date	February 2017
Contact information	Afsaneh Talebi Iran University of Medical Sciences, School of Nursing and Midwifery Yasemi Rashid street, Valiasr street, Tehran. Iran, Islamic Republic Of 00982143651820 Talebi.a@tak.iums.ac.ir / AfsanehTalebi68@gmail.com
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