Effect of alpha lipoic acid (ALA) on sperm parameters, DNA and oxidative stress in infertile men with increased sperm DNA damage
Design
Previous studies have indicated that the level of oxidative stress in infertile people is significantly higher than fertile individuals, the outcomes are sperm DNA damage, decreased fertilization, pregnancy and live birth as well as increased abortion. Therefore, treatment with antioxidants can be considered as one of the effective methods for improving sperm parameters. ALA is a unique antioxidant that can dissolve in water and fat and can significantly reduce the level of oxidative stress in the cells. In this research, triple blind clinical trial was done for 2 groups of 40 people. placebo group used two 300mg cap and treatment group uses two 300mg alpha Lipoic acid cap for 3 months.
Settings and conduct
After selecting patients in Royan Research Institute, patients randomly divided into two groups: placebo and the group receiving ALA. in this research, triple blind clinical trial was done for 2 groups of 40 people. placebo group used two 300mg cap and treatment group uses two 300mg alpha Lipoic acid cap for 3 months. Before and after three months, the routine and functional parameters of sperm will be examined.
Participants/Inclusion and exclusion criteria
Infertile men with normal sperm parameters and high DNA damage
Infertile men with abnormal sperm parameters and high DNA damage
Intervention groups
Placebo group usage two 300 mg Placebo Cap. per day and ALA treatment group usage two 300 mg Alpha Lipoic Acid Cap. per day
Main outcome variables
The routine sperm analysis and sperm functional tests includes DNA fragmentation and ROS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190406043177N1
Registration date:2019-08-21, 1398/05/30
Registration timing:retrospective
Last update:2019-08-21, 1398/05/30
Update count:0
Registration date
2019-08-21, 1398/05/30
Registrant information
Name
Masoud Habibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2746
Email address
mhabibi@mrcjd.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of alpha lipoic acid on sperm parameters, DNA integrity and oxidative stress in infertile men with increased level of sperm DNA damage
Public title
Effect of alpha lipoic acid on male infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile men with normal sperm parameters and high levels of DNA fragmentation (SCSA>30 , TUNEL>15)
Infertile men with abnormal sperm parameters and high levels of DNA fragmentation (SCSA>30 , TUNEL>15)
Exclusion criteria:
Varicocele
Leukocytospermia
cancer and chemotherapy
cytotoxic medicine usage
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug and placebo package was similar and was given to patients by the pharmacist according to the numbers in randomization. The patient himself did not have any information on the use of the medicine or the placebo. The laboratory expert and researcher only analyzed the samples by the numbers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Royan Institute
Street address
Royan Institute, Hafez St., Banihashem St, Tehran
City
Tehran
Province
Tehran
Postal code
16655659911
Approval date
2019-01-16, 1397/10/26
Ethics committee reference number
IR.ACECR.ROYAN.AEC.1397.108
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
DNA Damage
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
Flow cytometry device. Fluorescence and optic microscope
2
Description
sperm motility
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
CASA Device
3
Description
sperm morphology
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
microscope
4
Description
sperm count
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
neobar lam
5
Description
sperm vitality
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
microscope
6
Description
Lipid peroxidation (MDA level)
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
spectrophotometer
7
Description
Mitochondrial membrane potential
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
Flow Cytometry device
8
Description
TAC
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
ELISA Reader
9
Description
SOD
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
ELISA Reader
10
Description
GPX
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
ELISA Reader
11
Description
ROS
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
Flow Cytometry device
12
Description
Chromatin evaluation
Timepoint
Before starting the intervention - after 3 month use of medicine or placebo
Method of measurement
Flow Cytometry device
Secondary outcomes
1
Description
Fertilization Rate
Timepoint
After Treatment
Method of measurement
Patient Flow up and Fertility Tests
Intervention groups
1
Description
Control group: 3 month usage of placebo
Category
Placebo
2
Description
Intervention group: 3 month usage of 2 Cap. 300 mg alpha lipoic acid Bd before Breakfast and Lunch