The aim of this study is to evaluate the effect of folic acid, Vitamin E and selenium on the number, motility, morphology of sperms and white cells in the semen of men with idiopathic infertility.70 of the men who are suffering with idiopathic infertility and recourse to infertility center of Ghadir hospital and outpatient clinics of Shiraz University of Medical Sciences and During two consecutive analyzes at least one of the sperm parameters was impaired and during laboratory and radiological investigations, no anatomical and hormonal disorder diagnosed are enrolled in this study. According to The method of random block permutation participants assigned to two experimental and control groups. Then all samples are taught that do not have intercourse for 3 to 5 days and go for testing. Patients are recommended for masturbation method collect semen in a clean container and not having intercourse to collect semen sample because of the risk of contamination. After 24 hours the test report is provided. And if researchers desired parameters are disrupted (patients who have inclusion criteria ) for 12 weeks daily 5mg tablet of folic acid Galinuse, 200 mcg tablets selenium Nature Med and 400 IU vitamin E Zahravi are given to the experimental group and in this period participants in control group are given placebo. During these 12 weeks patients are evaluated with a phone call about how to eat supplements. At the end of 12 weeks analysis will be repeated and difference before and after intervention in both groups as well as between the two study and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012432153N1
Registration date:2017-06-17, 1396/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-17, 1396/03/27
Registrant information
Name
Rezvan Bahmyari
Name of organization / entity
School of Nursing and Midwifery, Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 77 3312 5676
Email address
stud35300572232@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Dr Basir Hashemi
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of folic acid, vitamin E, selenium on semen parameters in infertile men
Public title
Effect of folic acid, vitamin E, selenium on semen parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Tendency to participate in the study; Age range 25 to 54 years; Do not use of micronutrients out of study; Rejection of any obstructive disorder during radiological studies and anatomical examination; Abnormal parametres be approved by two semen analysis within two weeks
exclusion criteria: lake of Tendency to participate in the study; Azoospermia or Aspermia men; Men with sever varicocele; Recent urogenital infection that have been treated with antioxidants; History of allergic reactions to micronutrients; treated with the following drugs: sulfasalazine- methotrexate-Nitrofurantoin -colchicine –alpha blockers and cimetidine - spironolactone-antidepressants, beta-blocker-phenothiazine-metoclopramide-heroin- cocaine-cannabis-thiazide diuretic
Age
From 25 years old to 54 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethic committee of Shiraz University of Medical Sciences
Street address
No 60 ,Zand street, Shiraz University of Medical Sciences,Shiraz, Iran
City
Shiraz
Postal code
Iran
Approval date
2017-01-08, 1395/10/19
Ethics committee reference number
IR.SUMS.REC.1395.160
Health conditions studied
1
Description of health condition studied
male infertility
ICD-10 code
N46
ICD-10 code description
Azoospermia NOS - Oligospermia NOS
Primary outcomes
1
Description
sperm morphology
Timepoint
Before intervention ninety days after intervention
Method of measurement
semenal analysis
2
Description
Sperm count
Timepoint
Before and ninety days after intervention
Method of measurement
semenal analysis
3
Description
Sperm motility
Timepoint
Before and ninety days after intervention
Method of measurement
semenal analysis
4
Description
White blood cell count
Timepoint
Before and ninety days after intervention
Method of measurement
semenal analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Daily intake of 200 micrograms of selenium tablets nature med Manufacturing Co., 400 IU of vitamin zahravi Manufacturing Co. i, 5 mg folic acid tablets Galinuse Manufacturing Co. , once-daily, orally for 12 weeks
Category
Treatment - Drugs
2
Description
control group:Placebo daily for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
former mother and child hospital
Full name of responsible person
Azima sara
Street address
أNo 73,School of Nursing and Midwifery,Nemazee squair, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
No 60 ,Zand Street, Shiraz University of Medical Sciences,Shiraz,Iran
City
Shiraz
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 of Shiraz 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
School of Nursing and Midwifery, Shiraz
Full name of responsible person
Azima Sara
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
أNo 73,School of Nursing and Midwifery,Nemazee squair, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
azimas@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Shiraz
Full name of responsible person
Azima Sara
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
أNo 73,School of Nursing and Midwifery,Nemazee squair, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
+98 36474252
Email
Azimas@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of midwifery ,School of Nursing and Midwifery,Shiraz University of Medical Scientes, Shir
Full name of responsible person
Azima Sara
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
أNo 73,School of Nursing and Midwifery,Nemazee squair, Shiraz, Iran
City
Shiraz
Postal code
Iran
Phone
+98 71 3647 4254
Fax
+98 36474254
Email
Azimas@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)