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IRCT2016111830947N1 IRCT 2017-04-02 Vice chancellor for research, Iran University of Medical Sciences The Effect of Oral Vitamin D3 Supplementation on Spermogram Quantitative and Qualitative Indicators in Infertile Male The Effect of Oral Vitamin D3 Supplementation on Spermogram Quantitative and Qualitative Indicators in Infertile Male 2017-02-19 anticipated 60 Complete https://irct.ir/trial/24446 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Infertility. Intervention 1: Intervention group: the supplement of vitamin D3 for 12 weeks (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. Intervention 2: control group: Placebo of vitamin D3 for 12 weeks (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.
public Afsaneh Talebi
School of nursing and midwifery,Yasemi Rashid street, Valiasr street, Tehran.
Tehran Iran (Islamic Republic of) +98 21 4365 1820 Talebi.a@tak.iums.ac.ir؛AfsanehTalebi68@gmail.com Iran University of Medical Sciences, School of Nursing and Midwifery scientific Leila Amini
School of nursing and midwifery,Yasemi Rashid street, Valiasr street, Tehran.
Tehran Iran (Islamic Republic of) +98 21 4365 1820 Amini.l@iums.ac.ir Iran University of Medical Sciences, School of Nursing and Midwifery Iran (Islamic Republic of) Iran (Islamic Republic of) 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 nonـtherapeutic doses in last 3 months؛ not to intake medications that influence on the level of vitamin D3 includes، glucocorticoids and anti convulsion؛ the 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 liter؛ no disorder in prolactine levels or TSH. exclusion criteria: not taking more than one dose of vitamin D3؛ the existence of some signs or symptoms wich prohibit the continuous of using according to urologist and nutritionnist؛ start taking other supplements drugs that have been banned their entry criteria during the study 20 years 45 years Male n46 Male infertility Treatment - Drugs Treatment - Drugs Intervention group: the supplement of vitamin D3 for 12 weeks (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 group: Placebo of vitamin D3 for 12 weeks (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 Spermogram Qualitative Indicators. Timepoint: Patients are tested twice for Spermogram Qualitative Indicators.(one day before the first day of training – one day after the final day training course). Method of measurement: Spermogram. Spermogram Quantitative Indicators. Timepoint: Patients are tested twice for Spermogram Quantitative Indicators.(one day before the first day of training – one day after the final day training course). Method of measurement: Spermogram. Hormonal markers related to spermatogenesis(LH، FSH، TT، FT، SHBG. Timepoint: Patients are tested twice for Hormonal markers related to spermatogenesis.(one day before the first day of training – one day after the final day training course). Method of measurement: Evaluation of serum levels. Vice chancellor for research, Iran University of Medical Sciences Approved 2016-12-14 Ethics committee of Iran University of Medical Sciences School of nursing and midwifery، Yasemi Rashid street، Valiasr street، Tehran Tehran Iran (Islamic Republic of)