The aim of this study is to assess the effect of palm pollen on PRDX1 and PRDX6 antioxidant gene expression in oligospermic men. In this study, oligospermic patient whose diagnosed by an urologist, subdivided in case and control groups. control group patient received only conventional treatment, Whereas, case group treated with conventional treatment and Date Palm Pollent component. 2 to 4 days after the last sexual intercourse, semen from 60 individuals will be collected by masturbation. Inform written consent is given to all participant. Samples will be collected before and after intervention. Inclusion criteria are as follows: normal anatomy and infertility due to oligospermia; Exclusion criteria are as follows: genital infection; individuals with prostatitis; inflammation of the ducts; epididymitis; orchidism and mumps; also Genetic diseases affecting fertility such as (Klinefelter, XX men, Noonan syndrome, chromosome Y microdeletion, mitochondrial DNA mutations). To semen analysis, all samples are aliquoted in RNAs- DNAs free tubes containing 1 ml of sperm freez reagent and storage in -80°C nitrogen tank for Molecular testing and measuring enzyme activity in semen.
In this experiment, 1 g of Magza herbal capsules (containing palm pollen and other compounds), will be given to the case groups 4 times a day for a month (after palm pollen usage molecular testing and gene expression will be done).the randomization is done by permutation.Computer assissted semen analysis will be done according to World Health Organization standards.
The primary outcome of this study is change in count, motility and morphology of sperm and change in PRDX1,PRDX6 antioxidant gene expression
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021221014N2
Registration date:2015-12-29, 1394/10/08
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-12-29, 1394/10/08
Registrant information
Name
Kianoosh Malekzadeh
Name of organization / entity
Hormozgan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 76 3335 4939
Email address
kianoosh.malekzadeh@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of palm pollen on PRDX1,PRDX6 antioxidant gene expression in oligospermic men
Public title
The study of palm pollen effect on sperm parameters in oligosperm men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: normal anatomy and infertility due to oligospermia;
Exclusion criteria: genital infection; previous complementary therapies; individuals with prostatitis; inflammation of the ducts; epididymitis; orchidism and mumps; also Genetic diseases affecting fertility such as (Klinefelter, XX men., Noonan syndrome, chromosome Y microdeletion, mitochondrial DNA mutations); a history of hernia surgery; vasectomy and antioxidant drugs.
Age
From 20 years old to 45 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were divided in two groups,30 members in each group according to block randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hormozgan University of Medical Sciences Ethics Committee
Street address
Department of Research and Technology, Shahid Mohammdi Hospital, Jomhouri Blvd
City
Bandar abbas
Postal code
7919915519
Approval date
2015-03-16, 1393/12/25
Ethics committee reference number
HEC-93-12-19/1
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Azoospermia NOS Oligospermia NOS
Primary outcomes
1
Description
Change in count, Motility and morphology of sperm
Timepoint
3 months after intervention
Method of measurement
Semenalysis,Use of Questionnaire
2
Description
change in PRDX1,PRDX6 antioxidant gene expression
Timepoint
3 months after intervention
Method of measurement
evaluation of gene expression with Real time PCR Method.
Secondary outcomes
1
Description
Change of sperm PH and change in libido
Timepoint
3 months after intervention
Method of measurement
Semenanalysis and according to patient statements
Intervention groups
1
Description
Intervention of case group: Mogza capsule (1 g): Phoenix dactylifera pollen (0.5 gram); Nigella Satvia seed powder(0.3 gram); Colchicum seed powder(0.1 gram); Alpinia seed powder (0.1 gram) that patients are given four times a day.
Category
Treatment - Drugs
2
Description
Intervention Control: Vitamin E 400 unit per day; L-Carnitine daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hormozgan Fartility and Infertility center
Full name of responsible person
Kianoosh malekzadeh
Street address
Hormozgan Fartility and Infertility center,Shariati Hospital
City
Bandar abbas
2
Recruitment center
Name of recruitment center
Omme leila IVF Center
Full name of responsible person
Kianoosh malekzadeh
Street address
City
Omme leila IVF Center-Omme leila Hospital
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Bandar abbas University of Medical Science
Full name of responsible person
Kianoosh malekzadeh
Street address
Department of Research and Technology, Shahid Mohammdi Hospital, Jomhouri Blvd
City
Bandar abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Bandar abbas 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
Molecular Medicine Research Center
Full name of responsible person
Kianoosh malekzadeh
Position
Faculty of medicine, Hormozgan University of Medical Sciences
Other areas of specialty/work
Street address
Department of Research and Technology, Shahid Mohammdi Hospital,Jomhouri Blvd
City
Bandar abbas
Postal code
7919915519
Phone
+98 76 3333 7192
Fax
Email
Keyanoosh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Molecular Medicine Research Center
Full name of responsible person
Kianoosh malekzadeh
Position
Faculty of medicine, Hormozgan University of Medical Sciences
Other areas of specialty/work
Street address
Department of Research and Technology, Shahid Mohammdi Hospital, Jomhouri Blvd
City
Bandar abbas
Postal code
Phone
+98 76 3333 7192
Fax
Email
Keyanoosh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Molecular Medicine Research Center
Full name of responsible person
Alimohammad falahati
Position
Master of science in medical genetic, Hormozgan University of Medical Sciences
Other areas of specialty/work
Street address
Department of Research and Technology, Shahid Mohammdi Hospital, Jomhouri Blvd
City
Bandar abbas
Postal code
7919915519
Phone
+98 76 3333 7192
Fax
Email
Falahatidiamond@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)