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Analysis of sesame effect on oxidative stress parameters of sperm analysis in infertility of men due to oxidative stress agents in Hamadan.

Protocol summary

Summary
In this study we compare the concentration of semen, sperm morphology, sperm motility, TAC, MDA, ROS and DNA Fragmentation before and after treatment. In this study, single-center to study the effect of sesame on oxidative stress parameters in men with infertility due to sperm analysis of oxidative stress in patients with a diagnosis of infertility in Hamedan city from January 94 to February 95 due to oxidative stress clinic Infertility come Fatemieh carried out. the number of patients studied 50 people who Sesame 30 grams daily for 3 months for them to be used. Exclusion criteria patients with azoospermia, absence of evidence of oxidative stress in semen, sesame seeds and a lack of sensitivity to the patient's consent to participate in the study or continue to participate in the study. 30 g of sesame is used for all patients. the amount of recovery based on comparison of the concentration of semen, sperm morphology, sperm motility, TAC, MDA, ROS and DNA Fragmentation is examined before and after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020719885N2
Registration date: 2016-05-12, 1395/02/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-12, 1395/02/23
Registrant information
Name
Hazhir Seifpanahi-Shabani
Name of organization / entity
Hamadan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0315
Email address
h.seifpanahi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Hamadan University of Medical Sciences.
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analysis of sesame effect on oxidative stress parameters of sperm analysis in infertility of men due to oxidative stress agents in Hamadan.
Public title
Sesame and Infertility of Men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile men who referred to infertility clinic of Fatemieh hospital with the evidence of oxidative stress in their semen fluid through TAC and MDA and ROS and DNA Fragmentation measured. Exclusion criteria: Azoospermia; absence of evidence of oxidative stress in semen; sensitivity to sesame seeds; lack of patient consent for participation in the study or to continue participate in the study.
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ethics Committee of Hamadan University of Medical Science
Street address
Shahid Fahmideh St, Vice Chancellor for Research Hamadan University of Medical Sciences.
City
Hamadan
Postal code
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
پ/16/35/9/707

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility

Primary outcomes

1

Description
Oxidative stress
Timepoint
At the beginning of the study and three months after the study began
Method of measurement
Computer assisted sperm analysis & DNA fragmentation assay kit

Secondary outcomes

empty

Intervention groups

1

Description
Daily consumption of 30 grams of sesame for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Infertility Clinic
Full name of responsible person
Dr Mahnaz Yavangui
Street address
Fatemieh Medical Center, Street Kermanshah, Hamadan.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Researc‌h, Hamadan University of Medical Science.
Full name of responsible person
Mrs Yadollahzadeh
Street address
Shahid Fahmideh St, Vice Chancellor for Research Hamadan University of Medical Sciences, Hamadan.
City
Hamadan
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, Hamadan 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
Student Research Center, University of Medical Sciences
Full name of responsible person
Hazhir Seifpanahi-shabani
Position
Medical Intern
Other areas of specialty/work
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences, Hamadan.
City
Hamadan
Postal code
Phone
+98 81 3838 0315
Fax
Email
h.seifpanahi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Obstetrics and Gynecology University of Medical Sciences
Full name of responsible person
Dr Mahnaz Yavangui
Position
Gynecologist, Fellowship of Infertility
Other areas of specialty/work
Street address
Fatemieh Medical Center, Kermanshah St, Hamadan.
City
Hamadan
Postal code
Phone
+98 81 1828 3939
Fax
Email
m_yavangui@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student Research Center, Hamadan University of Medical Scienses
Full name of responsible person
Hazhir Seifpanahi-shabani
Position
Medical Intern
Other areas of specialty/work
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0315
Fax
Email
h.seifpanahi@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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