The effect of Alpha lipoic acid supplementation on gene expression and activity of Glutathione S-Transferase and spermatogram in idiopathic asthenozoospermic males: A randomized, triple-blind, placebo-controlled clinical trial
The present study was designed to determine the effects of Alpha-lipoic acid supplementation on semen quality, seminal antioxidant enzymes, oxidative stress and the gene expression and activity of Glutathione S-Transferase of sperm in idiopathic oligoasthenoteratozospermic men referring to treatment center Ahvaz University of Medical Sciences. In a randomized placebo-controlled trial,40 infertile men aged between 20-45 years with idiopathic oligoasthenoteratozoosperia and at least 1 year history of infertility selected. The enrolled patients underwent dietary implementation of Alpha-lipoic acid 600 mg twice daily (300mg) or placebo For 12 weeks. During this study, the total antioxidant capacity (TAC) and serum malondialdehyde (MDA) and the gene expression and activity of Glutathione S-Transferase of sperm are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013111010181N3
Registration date:2013-11-15, 1392/08/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-11-15, 1392/08/24
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
haidari-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Ahvaz Jundishapur University of Medical Science
Expected recruitment start date
2013-11-16, 1392/08/25
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Alpha lipoic acid supplementation on gene expression and activity of Glutathione S-Transferase and spermatogram in idiopathic asthenozoospermic males: A randomized, triple-blind, placebo-controlled clinical trial
Public title
The effect of Alpha lipoic acid supplementation on male infertility
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 antioxidant supplements during last 3 months.
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:
40
Randomization (investigator's opinion)
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
Ahvaz Jundishapur University of Medical Science
Street address
Golestan Ave. Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Postal code
Approval date
2013-10-12, 1392/07/20
Ethics committee reference number
150
Health conditions studied
1
Description of health condition studied
Asthenospermia
ICD-10 code
N46
ICD-10 code description
male infertility
Primary outcomes
1
Description
sperm motility
Timepoint
12 weeks
Method of measurement
spermatogram
Secondary outcomes
1
Description
gene expression and activity of Glutathione S-Transferase
Timepoint
12 weeks
Method of measurement
Real Time-PCR- Spectrophotometric
Intervention groups
1
Description
Control group:Placebo
placebo: Lactose, 12 weeks, 2 capsule(300 mg) per day
Category
Treatment - Drugs
2
Description
Intervention group:Alfa lipoic acid 600 mg per day for12 weeks, 2 capsule per day(300mg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Imam Khomeini Hospital, Ahwaz University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Heidari
Street address
Infertility Center of Imam Khomeini Hospital, Ahwaz University of Medical Sciences.Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Feghhi
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Ave.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Science
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
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Fatemeh Heidari
Position
Associate Professor
Other areas of specialty/work
Street address
Golestan Ave.Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Postal code
Phone
+98 61 1373 8330
Fax
Email
Haidari58@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Fatemeh Heidari
Position
Associate Professor
Other areas of specialty/work
Street address
Golestan Ave.Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Postal code
Phone
+98 61 1373 8330
Fax
Email
Haidari58@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Fatemeh Heidari
Position
Associate Professor
Other areas of specialty/work
Street address
Golestan Ave. Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1373 8330
Fax
Email
Haidari58@gamil.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)