The purpose of this study is to evaluate the effect of red grape seed extract on the semen parameters of men who involved idiopathic infertility. The cases consist of about 50 idiopathic infertile men, aged between 20-45 years old, who refer to Royan infertility center in 2010. This is a parallel group randomized controlled trial. The selected patients will be assigned in 2 groups as intervention and control. At first, ROS level in semen plasma and 2 semen analysis will be measured and then all patients will receive their medications (medicine or placebo) for three months. Then, ROS level and 2 semen analysis will be measured again after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010034861N1
Registration date:2010-10-25, 1389/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-25, 1389/08/03
Registrant information
Name
Reza Salman Yazdi
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 6478
Email address
r.salmanyazdi@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute, Urology & Nephrology Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-03-19, 1389/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of red grape seed extract on idiopathic infertile male patients’ spermogram at Royan infertility center in 2010
Public title
The effect of red grape seed extract on human semen parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Oligozoospermia with sperm count 5-20 million/ml and astenozoospermia with progressive motility less than 40%
Exclusion criteria: Explained infertility (e.g. hormonal disorders, epididimis canal obstruction, epididimorchitis,...) smoking, drug or alcohol addiction, diabetes, renal disorders (creatinine more than 2.0 times), chronic liver diseases (transaminase more than twice as much normal), varicocele, infectious diseases indicated with fever and leukocytosis, sexual arousing-drugs consumption
Age
From 20 years old to 45 years old
Gender
Male
Phase
0
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
Royan Institute
Street address
No.12 Hafez st., bani-hashem st., Resalat Ave.,
City
Tehran
Postal code
16656-59911
Approval date
2010-09-28, 1389/07/06
Ethics committee reference number
006/89/ک
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 Motility
Timepoint
before intervention and a week after intervention
Method of measurement
Motility velocity and percentage
2
Description
ROS (Reactive Oxygen Species) levels
Timepoint
before intervention and a week after intervention
Method of measurement
Concentration assay by chemiluminesence method
3
Description
Sperm Concentration
Timepoint
before intervention and a week after intervention
Method of measurement
Counting the sperms
Secondary outcomes
1
Description
FSH level
Timepoint
Befor intervention and a week after intervention
Method of measurement
ELISA
2
Description
LH level
Timepoint
Befor intervention and a week after intervention
Method of measurement
ELISA
3
Description
Testosterone level
Timepoint
Befor intervention and a week after intervention
Method of measurement
ELISA
Intervention groups
1
Description
Intervention:
Red Grape Seed Extract, Capsule 300mg, Twice/day, for 3 months
Category
Treatment - Drugs
2
Description
Control:
Placebo, Capsule 300mg, Twice/day, for 3 months