Protocol summary
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Study aim
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The aim of this study was to investigate:
The effect of palm pollen on sexual parameters
As well as the expression of antioxidant genes
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. Palm pollen at a dose of 400 mg / kg in gelatin capsules was used for two consecutive months to treat eligible individuals. The control group was selected. Semen samples were analyzed before and after palm pollen treatment in the case group and also semen samples in the control group according to WHO guidelines.
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Participants/Inclusion and exclusion criteria
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Infertile men aged 20 to 42 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 months.
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Main outcome variables
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Changes in sperm parameters
Sex hormones and prolactin
free 8-Isoprostane
Expression of SOD-CAT-NRF2-GPX4 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:
IRCT2015020120895N2
Registration date:
2015-10-12, 1394/07/20
Registration timing:
prospective
Last update:
2021-05-03, 1400/02/13
Update count:
1
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Registration date
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2015-10-12, 1394/07/20
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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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Vice chancellor for research, Hormozgan University of Medical Sciences
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Expected recruitment start date
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2016-03-21, 1395/01/02
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Expected recruitment end date
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2017-09-23, 1396/07/01
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Actual recruitment start date
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2016-03-12, 1394/12/22
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Actual recruitment end date
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2017-06-11, 1396/03/21
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Trial completion date
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2017-06-22, 1396/04/01
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Scientific title
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Evaluation of the Antioxidant Role of Palm Pollen in Oligospermic and Asthenozoospermic Men and Its Correlation with Count, Motility and Morphology of the Sperm
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Public title
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Antioxidant role of palm pollen in infertility
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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 42 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
120
Actual sample size reached:
80
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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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This study is a randomized, single-blind and comparative clinical trial including 60 cases of male infertility that was conducted during the year March to June 17, 2016. Palm pollen powder at a rate of 400 mg / kg in gelatin capsules was used for two consecutive months to treat eligible individuals.Have been received. 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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Other
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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 palm pollen capsule for two months 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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2015-02-23, 1393/12/04
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Ethics committee reference number
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HEC-93-12-4
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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Evaluation of count, motility and morphology of sperm
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Timepoint
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2 months
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Method of measurement
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Semen analysis
2
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Description
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Evaluation of expression of antioxidant SOD, CAT, GPX, NRF2 and KEAP1 genes
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Timepoint
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2 months
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Method of measurement
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RT-PCR
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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2 months after consumption of 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.
2
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Description
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Measurement of antioxidant genes and 8- isoprene index
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Timepoint
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After two months, receive palm pollen
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Method of measurement
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BSA-free Ham’s-F10 was used twice to wash the samples and then stored in RNALater solution (Qiagen: Germany) at -80 ° C until RNA extraction. Then, after extraction and PCR test, real-time test was performed on the samples.
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 palm pollen powder in gelatin capsules for two months.
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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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Abstract and original article after publication
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When the data will become available and for how long
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two months
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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To conduct scientific research
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From where data/document is obtainable
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To the clinical trial site
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What processes are involved for a request to access data/document
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Email - Call - SMS
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Comments
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