(1) Objectives: The aim of this study is to determine the effect of Oral Vitamin D3 Supplementation on Spermogram Quantitative and Qualitative Indicators in Infertile Male.(2) Design: Participations are divided into 2 groups(intervention and control).(3) Setting and Conduct:in this study 60 subjects 20-45 years of infertile men with abnormal spermogram undergoing infertility treatment.(4) inclusion criteria: body mass index is 18/5-30؛ not to intake any vitamin D3 at therapeutic doses in last 3 months؛ having disrupt sperm of unknown origin(idiopatice)؛ the serum level of vitamin D3 should be less than 30 or equal to 30 Ng in liter؛ lack of anatomical abnormalities of the genital tract such as varicocele grade two and above، Testes and vas deferens history of surgery.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.(5) interventions، 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).(6) outcomes studied: Quantitative and qualitative indicators of sperm and hormones related to spermatogenesis in Infertile Mails.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111830947N1
Registration date:2017-04-02, 1396/01/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-02, 1396/01/13
Registrant information
Name
Afsaneh Talebi
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 26 3340 1207
Email address
talebi.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Oral Vitamin D3 Supplementation on Spermogram Quantitative and Qualitative Indicators in Infertile Male
Public title
The Effect of Oral Vitamin D3 Supplementation on Spermogram Quantitative and Qualitative Indicators in Infertile Male
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
School of nursing and midwifery، Yasemi Rashid street، Valiasr street، Tehran
City
Tehran
Postal code
Approval date
2016-12-14, 1395/09/24
Ethics committee reference number
IR.IUMS.REC 1395.9311373019
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
n46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AkbarAbadi Hospital in Tehran
Full name of responsible person
Afsaneh Talebi
Street address
AkbarAbadi Hospital in Tehran, Ferdose garden station, Molavi street,Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Urology Clinic Doctor Said Sahebkashaf
Full name of responsible person
Afsaneh Talebi
Street address
Urology Clinic Doctor Said Sahebkashaf, Sabounchi Street, Beheshti Martyr Street,Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Morteza Naserbakht
Street address
Iran University of Medical Sciences, Next to Milad tower, Hemmat highway, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Afsaneh Talebi
Position
MSc Student of Midwifery
Other areas of specialty/work
Street address
School of nursing and midwifery,Yasemi Rashid street, Valiasr street, Tehran.
City
Tehran
Postal code
Phone
+98 21 4365 1820
Fax
Email
Talebi.a@tak.iums.ac.ir؛AfsanehTalebi68@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Leila Amini
Position
Assisstant of professor
Other areas of specialty/work
Street address
School of nursing and midwifery,Yasemi Rashid street, Valiasr street, Tehran.
City
Tehran
Postal code
Phone
+98 21 4365 1820
Fax
Email
Amini.l@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Afsaneh Talebi
Position
MSc Student of Midwifery
Other areas of specialty/work
Street address
School of nursing and midwifery, Yasemi Rashid street, Valiasr street,Tehran.
City
Tehran
Postal code
Phone
00
Fax
Email
Talebi.a@tak.iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)