The aim of this study is to determine the effect of pomegranate juice (PJ) on sperm parameters including count, motility and morphology, also the rate of sperm apoptosis and DNA structure of sperm. Sample is 35 infertile male aged 20-40 years that refer to Yazd research & clinical center of infertility that their sperm analysis showed that at least one of the tree sperm parameters are abnormal. If they are smoker or opioid abuse, have any history of surgery or diseases of reproductive region or any systemic disease , they will be exclude from study. We test sperm apoptosis by TUNEL test and chromatin structure by CMA3 (Chromomycin A3) and SCD(sperm chromatin dispersion), then patients get PJ (from Shadli Co.) 200cc daily for 10 weeks and then all the tests will be repeat. Because of antioxidant activity of PJ, it is suppose that the outcome will be improvement of sperm parameters, decrease of sperm apoptosis and improvement in structure of sperm chromatin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804262168N2
Registration date:2009-08-07, 1388/05/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2009-08-07, 1388/05/16
Registrant information
Name
Ali Reza Talebi
Name of organization / entity
Department of biology, Shahid Sadoughi university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 7085
Email address
prof_talebi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
yazd research & clinical center of infertility - Research Institute for Islamic & Complementary Medicine
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-01-21, 1388/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pomegranate juice consumption on sperm parameters , structure of chromatin of sperm nucleus and sperm apoptosis in infertile men
Public title
Study the effect of pomegranate juice on infertile male sperm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: abnormality in at least one of 3 sperm parameters (count, motility or morphology), age between 20 - 40 years old
Exclusion criteria: history of cryptorchidism, varicocele, trauma, azoospermia, any surgery on testis region, specific systemic disease, using systemic disease drug, chronic disease drug or any drug to treat genital system, smoking or opioid abuser.
Age
From 20 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shaheed Sadoughi University of medical sciences and health services
Street address
Shaheed Sadoughi University of medical sciences and health services, Bahonar square
City
Yazd
Postal code
Approval date
2008-02-11, 1386/11/22
Ethics committee reference number
72934/1/17/پ
Health conditions studied
1
Description of health condition studied
Azoospermia and Oligospermia
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
improvement of structure of sperm chromatin
Timepoint
10 weeks after intervention
Method of measurement
CAM3 test & SCD test
2
Description
improvement of sperm parameters
Timepoint
10 weeks after intervention
Method of measurement
sperm analysis with microscope & macler chamber
3
Description
decrease of sperm apoptosis
Timepoint
10 weeks after intervention
Method of measurement
TUNEL test
Secondary outcomes
1
Description
side effect
Timepoint
during of intervention
Method of measurement
following
Intervention groups
1
Description
consumption of pomegranate juice 200cc/day for 10 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research & Cinical Cenetr for Infertility
Full name of responsible person
Dr. Abdoli A.M.
Street address
Buali avenue-Safaeie-Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Research & Clinical Center for Infertility
Full name of responsible person
Dr. Abdoli A.M.
Street address
Buali avenue-Safaeie-Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Research & Clinical Center for Infertility
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Research Institute for Islamic & Complementary Medicine
Full name of responsible person
Dr. Dabbaghian Fattane
Street address
No 1/423-Pirnia alley-North Lalezar avenue-Jomhuri Eslami avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic & Complementary Medicine
Proportion provided by this source
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
Shaheed Sadoughi University of medical sciences and health services
Full name of responsible person
Omid AminiRad
Position
Researcher
Other areas of specialty/work
Street address
Yazd Student Research Center-Shahid Sadughi hoapital-Shahid Ghandi avenue-safaeie-Yazd-Iran
City
Yazd
Postal code
Phone
+98 35182440003407
Fax
Email
omid_amini2007@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Research & Clinical Center for Infertility
Full name of responsible person
Dr. Khalili M.A.
Position
lecturer of embryology
Other areas of specialty/work
Street address
Buali avenue-Safaeie-Yazd-Iran
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
khalili59@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Sadoughi University of medical sciences and health services
Full name of responsible person
Omid AminiRad
Position
researcher
Other areas of specialty/work
Street address
Yazd Student Research Center-Shahid Sadughi hoapital-Shahid Ghandi avenue-safaeie-Yazd-Iran
City
Yazd
Postal code
Phone
+98 35182440003407
Fax
Email
omid_amini2007@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)