The aim of this study was to investigate the role of folic acid and zinc sulfate supplementation on improvement of sperm functions among infertile male with oligoasthenoteratozoospermia but not anatomical and other impotency cases. Four groups of 25 infertile men including groups supplemented with Folic acid/Zinc, Folic acid/ placebo, Zinc/placebo and placebo/placebo to demonstrate the effect of individual supplement in fertility and sperm function tests. Intervention include above 4 experiment modes of supplementation. 16 weeks after treatment; semen analysis and sperm function test were measured as primary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706091079N2
Registration date:2011-07-18, 1390/04/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-18, 1390/04/27
Registrant information
Name
Mohammad Reza Sadeghi
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2024
Email address
sadeghi@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Iranian Academic Center for Education ,Culture and Research (ACECR)
Expected recruitment start date
2007-05-31, 1386/03/10
Expected recruitment end date
2008-10-01, 1387/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Zinc and Folic Acid on sperm function test in infertile men
Public title
Effect of Zinc and Folic Acid on semen analysis and sperm function
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:infertile men with oligoasthenoteratozoospermia, 20-45 years old
exclusion criteria: men with severe and chronic underlaying disease such as dibet, SC disabilities.
Age
From 20 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Research Institute
Street address
Avicenna Research Institute, Shahid Beheshti University, Evin, Tehran, Iran
City
Tehran
Postal code
1983969411
Approval date
2006-11-21, 1385/08/30
Ethics committee reference number
85/3496
Health conditions studied
1
Description of health condition studied
Male Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
sperm function test
Timepoint
before treatment commence and 16 weeks after treatment
Method of measurement
sperm function tests according to WHO standard
2
Description
semen analysis
Timepoint
before treatment commence and 16 weeks after treatment