Study of the effects of sesame seeds on oxidative stress and sperm parameters in semen samples of males with infertility related to oxidative stress in Hamedan.
Design
In this study, 50 patients with idiopathic infertility who have been admitted to Fatemieh Hospital of Hamadan are selected randomly and treated with sesame for a period of 3 months. It should be noted that sperm samples are collected before and after of treatment.
Settings and conduct
The sperm Samples of the patient after collecting in Fatemieh Hospital will be transferred to the Biochemistry Lab of Hamedan University of Medical Sciences to evaluate the oxidative and antioxidant tests.
Participants/Inclusion and exclusion criteria
Entry requirements include participants aged 29 to 40 with idiopathic infertility. Exclusion criteria for the study include those who are allergic to sesame seeds and azoospermic patients.
Intervention groups
The control group in this study was the patients before the intervention and the patient group included those who were under the intervention for 3 months.
Main outcome variables
Improvement of sperm parameters; Reduction of oxidative stress in sperm samples; Increasing antioxidant agent in sperm samples; Reducing sperm DNA damage
General information
Reason for update
Acronym
HIS
IRCT registration information
IRCT registration number:IRCT20171002036508N1
Registration date:2018-01-22, 1396/11/02
Registration timing:registered_while_recruiting
Last update:2018-01-22, 1396/11/02
Update count:0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
hadi ghasemi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 906 7823
Email address
h.ghasemi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
supported by Hamadan University of Medical
Sciences.
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analysis of sesame effect on parameters of sperm in infertility of men due to oxidative stress agents in Hamadan.
Public title
the effect of sesame on men infertility treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Idiopathic infertility
being 29-40 years old
Lack of underlying diseases
Exclusion criteria:
Azoospermia
Allergic reactions to sesame seeds
Patient with dissatisfaction to participation in the study or to continue
Individuals who have been used sesame seeds or its oil at the last three months
Age
From 29 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
The first sample is taken before the intervention and the next sample is taken after intervention
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
Hamadan University of Medical Sciences
Street address
Fahmideh Blvd. Mahdieh Ave., Hamadan-Iran
City
Hamadan
Province
Hamadan
Postal code
۶۵۶۷۱۷۱۶۳۵
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.UMSHA.REC.13960.252
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
DNA Fragmentation
Timepoint
Before the study and three months after the intervention began
Method of measurement
observation of DNA fragmentation with microscope
2
Description
sperm parameters
Timepoint
Before the study and three months after the intervention began
Method of measurement
evaluation of sperm motility and sperm morphology with CASA software
Secondary outcomes
1
Description
Total antioxidant capacity
Timepoint
Before the study and three months after the intervention began
Method of measurement
mmol/L measurment with commercial kit
2
Description
Total protein
Timepoint
Before the study and three months after the intervention began
Method of measurement
mg/dl measurment with bradford method
3
Description
Malondialdehyde
Timepoint
Before the study and three months after the intervention began
Method of measurement
nmol/ml measurment with commercial kit
4
Description
Total oxidant status
Timepoint
Before the study and three months after the intervention began
Method of measurement
mmol/L measurment with commercial kit
Intervention groups
1
Description
intervention group consumed 30 grams of sesame prescribed for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital-Hamedan-IRAN
Full name of responsible person
Dr. Iraj Amiri
Street address
District 1, Hamedan, Hamadan Province
City
Hamadan
Province
Hamadan
Postal code
6567171635
Phone
+98 81 5822 4372
Fax
+98 81 5822 4372
Email
amiri@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr.Saeed Bashirian
Street address
Fahmideh Blvd. Mahdieh Ave., Hamadan-Iran
City
Hamadan
Province
Hamadan
Postal code
6567171635
Phone
+98 81 5822 4372
Fax
+98 81 5822 4372
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Iraj Amiri
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Fahmideh Blvd. Mahdieh Ave., Hamadan-Iran
City
Hamadan
Province
Hamadan
Postal code
6567171635
Phone
+98 81 3827 7013
Fax
Email
amiri@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Mohammad ali AmirZargar
Position
Urologist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Fahmideh Blvd. Mahdieh Ave., Hamadan-Iran
City
Hamadan
Province
Hamadan
Postal code
6567171635
Phone
+98 81 3827 7013
Fax
Email
amirzargar@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Hadi ghasemi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Fahmideh Blvd. Mahdieh Ave., Hamadan-Iran
City
Hamadan
Province
Hamadan
Postal code
6567171635
Phone
+98 81 3827 7013
Fax
Email
hadigh110@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the main outcome and the subordinate outcome, as well as data like the age that can not be identified, will be shared.
When the data will become available and for how long
The acceptability course will begin 5 months after the results printed.
To whom data/document is available
Access to published data will be possible for academic workers.
Under which criteria data/document could be used
Individuals working with healthcare organizations will be able to use the data to treat or assist the patient's treatment process.
From where data/document is obtainable
If necessary, access to the data can be obtained by contacting Dr. Iraj Amiri by e-mail; amiri@umsha.ac.ir
What processes are involved for a request to access data/document
Dear Applicants for access the related data can contact our colleagues by e-mail, they must submit confirmation and receive the data by submitting an academic email and an undertaking to prove that they do not misuse the data. It takes a maximum of 10 days.