Protocol summary
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Study aim
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The aim of this study: The Evaluation of Date Palm Pollen effect on sexual parameters As well as the expression of antioxidant genes and 8-isoprostane index of Sex hormones in infertile
Men
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Design
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single-blind and comparative clinical trial
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Settings and conduct
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This study was conducted during 2015. Date Palm Pollen at a dose of 400 mg/ kg in gelatin capsules was used for 74 consecutive days to treat eligible individuals.Ten fertile men was selected as control group. Semen samples were analyzed before and after Date Palm Pollen treatment in the case group and also semen samples were analyzed in the control group according to WHO guidelines. furthermore, the free 8-isoprostane levels and PRDX1 and PRDX6 antioxidant genes expression were evaluated.
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Participants/Inclusion and exclusion criteria
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Infertile men aged 20 to 45 years were included in the
study We excluded the case with these criteria from the
research: history of genetic and systemic disorders,
reproductive tract abnormality, testicular trauma, alcohol
and substance abuse, and fertility medications at least
for six months before participation.
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Intervention groups
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In order to intervene in the case group, in addition to
receiving standard infertility medication by a specialist
physician, they also received 400 mg / kg palm pollen
powder in gelatin capsules for two 74 days.
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Main outcome variables
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Changes in sperm parameters of Sex hormones,
free 8-Isoprostane levels and expression of PRDX1 and PRDX6 genes
General information
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Reason for update
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Increase the sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015021221014N2
Registration date:
2015-12-29, 1394/10/08
Registration timing:
prospective
Last update:
2021-12-11, 1400/09/20
Update count:
1
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Registration date
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2015-12-29, 1394/10/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Governmental
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Expected recruitment start date
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2016-03-27, 1395/01/08
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Expected recruitment end date
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2017-10-04, 1396/07/12
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Actual recruitment start date
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2016-03-18, 1394/12/28
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Actual recruitment end date
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2017-06-19, 1396/03/29
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Trial completion date
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2017-07-23, 1396/05/01
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Scientific title
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Evaluation of Date Palm Pollen on the expression of PRDX1 and PRDX6 antioxidant genes in infertile men
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Public title
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The study of Date Palm Pollen effect on sperm parameters in infertile men
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Normal anatomy of the genital area
Infertility due to oligo asthenospermia
Exclusion criteria:
The case with the following criteria were excluded from the study: history of genetic and systemic disorders.
reproductive tract abnormality
testicular trauma
alcohol and substance abuse
and fertility medications at least for six months before participation
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Age
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From 20 years old to 45 years old
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Gender
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Male
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
60
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization with sealed envelope
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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.The patien Have been received medicine in sealed encoded envelopes. The coding is done by one of the project partners and they are blind
evaluators.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Participants entered the study after signing a personal and written consent form based on inclusion criteria.Their cement sample was measured before and after treatment with Date Palm Pollen capsule for 74 days in the case group and also the sample of the control group was measured according to the WHO 2010 analysis analysis guidelines. Also, the concentration of 8-Isoprostane,antioxidant genes was examined.
Ethics committees
1
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Ethics committee
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Approval date
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2015-03-16, 1393/12/25
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Ethics committee reference number
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IR.HUMS.REC.1394.201
Health conditions studied
1
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Description of health condition studied
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Male infertility
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ICD-10 code
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N46
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ICD-10 code description
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Azoospermia NOS Oligospermia NOS
Primary outcomes
1
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Description
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Change in count, Motility and morphology of sperm
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Timepoint
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74 days after intervention
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Method of measurement
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Semen analysis
2
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Description
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change in PRDX1,PRDX6 antioxidant gene expression
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Timepoint
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74 days after intervention
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Method of measurement
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evaluation of gene expression using Real time PCR Method.
Secondary outcomes
1
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Description
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Semen samples were obtained twice from the case group, before and after treatment, and once from the control group through masturbation, masturbation and abstinence for three to five days. We then collected fresh semen samples in sterile plastic containers.
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Timepoint
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74 days after consumption of Date Palm Pollen
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Method of measurement
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The samples were exposed to 37 ° C for 30 minutes for liquefaction and semen analysis (fluid volume, pH,viscosity, sperm morphology, concentration and motility) was performed immediately according to the WHO guideline. Sex hormones were also examined using ELISA. In addition, in this clinical trial, a blind and comparative semen analysis was performed by a technician blindly.
Intervention groups
1
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Description
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In addition to standard treatment by a urologist, the case group received 400 mg / kg of Date palm pollen powder in gelatin capsules for 74 days.
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Category
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Treatment - Drugs
2
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Description
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Intervention Control: Vitamin E 400 unit per day; L-Carnitine daily
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bandare-abbas University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The study results will be published as an article. The study protocol and statistical analysis used in the article will be considered.
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When the data will become available and for how long
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It will be published a year after the study is completed
and will be available in the sources.
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To whom data/document is available
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Information will be made available after permission of the sponsor for academic researchers, physicians and academic institutions.
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Under which criteria data/document could be used
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Other researchers can use the results of the study in their review and meta-analysis.
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From where data/document is obtainable
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Dr Soghra fallahi, PhD by research, Hormozgan university of medical science
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What processes are involved for a request to access data/document
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upon request, the corresponding author will respond
after consulting with the sponsor of the study
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Comments
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