It is believed that environmental and nutritional factors are involved in infertility of men. Recent studies have shown that omega-3 fatty acids especially DHA is reduced in cell membrane of sperm in those with asthenospermia. The authors have treated these patients with DHA (Docosahexaenoic Acid)supplementation, but they could not find any progress. We think that if vitamin E plus DHA will be given to these patients, we will see the improvement in the motility of the sperm. In this study, we are going to see the effect of Omega-3 plus vitamin E on sperm motility in a double blind placebo controlled randomized clinical trial. The cases will be treated with 1000mg DHA plus 600mg vitamin E, and controls will be treated with placebo and 600 mg vitamin E. After 3 months, the spermogram and oxidative stress will be compared before and after treatment in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010054010N3
Registration date:2010-10-28, 1389/08/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-10-28, 1389/08/06
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
National nutrition research institute
Expected recruitment start date
2010-11-13, 1389/08/22
Expected recruitment end date
2012-03-12, 1390/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Omega-3 fatty acids plus vitamin E supplements on spermatogram and oxidative stress in infertile men with asthenozospermia
Public title
The effect of Omega-3 fatty acids plus vitamin E supplements on spermatogram and oxidative stress in infertile men with asthenozospermia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willing to participate in the study and filling out the informed consent form, they should be infertile (no conception after 12 months intercourse without any contraception), age 20-45 y.o, idiopathic asthenospermia according to WHO criteria, normal hormonal profile.
Exclusion criteria: any infection in genitourinary (GU) tract, any anatomical abnormality in GU tract, any chronic disease during last 3 months, any surgery in GU tract, consumption of omega-3 fatty acids and/or vitamin E supplements during last 3 months
.
Age
From 20 years old to 45 years old
Gender
Male
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Shahid Beheshti University
City
Tehran
Postal code
Approval date
2009-10-12, 1388/07/20
Ethics committee reference number
57
Health conditions studied
1
Description of health condition studied
Asthenospermia
ICD-10 code
N045
ICD-10 code description
male infertility
Primary outcomes
1
Description
sperm motility
Timepoint
3 months
Method of measurement
spermatogram
Secondary outcomes
1
Description
oxidative stress
Timepoint
3 months
Method of measurement
total antioxidant capacity and PGF2a
Intervention groups
1
Description
Control group: placebo 1g per day for 3 months + 600mg vitamin E
Category
Treatment - Drugs
2
Description
Intervention group: omega-3 fatty acids 1000mg per day for 3 months + 600mg vitamin E
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna clinic
Full name of responsible person
Azita Hekmatdoost
Street address
Niavaran Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition Research Institute
Full name of responsible person
Dr. Abdollahi
Street address
West Arghavan, shahrak ghods
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition Research Institute
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
National Nutrition Research Institute
Full name of responsible person
Azita Hekmatdoost, MD, PhD
Position
Assistant Prof.
Other areas of specialty/work
Street address
West Arghavan, Shahrak Ghods
City
Tehran
Postal code
Phone
+98 21 2235 7484
Fax
Email
a_hekmat2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Nutrition Research Institute
Full name of responsible person
Azita Hekmatdoost, MD, PhD
Position
MD, PhD
Other areas of specialty/work
Street address
West Arghavan, Shahrak Ghods
City
Tehran
Postal code
Phone
+98 21 2235 7484
Fax
Email
a_hekmat2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)