Evaluation the effects of Vitamine E and Selenium on the expression of Nox5 and HSPA2 in Astheniteratozoospermia men
Design
The treated group receives vitamin E and selenium for 3 months and the placebo group receives placebo for three months.
Settings and conduct
This study is double-blind, randomized, placebo- controlled trial study. The treated group received vitamin E and selenium for 3 months and the placebo group received placebo for 3 months. Variables are measured and compared in two groups before and after treatment.
Participants/Inclusion and exclusion criteria
Infertile men with teratosthenozoospermia aged 20 to 55 years old.
Intervention groups
Treated and placebo groups. The treatment group included 30 infertile men with teratosthenozoospermia who received daily vitamin E (400 IU) in combination with selenium (200μg) and the placebo group consisted of 30 infertile men with teratosthenozoospermia who received two placebo tablets (same color) daily for three months.
Main outcome variables
Assessment of Sperm Parameters; Apoptosis and Sperm Protamine Deficiency; HSPA2 assay; NOX5; Intracellular Superoxide Anion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140409017210N2
Registration date:2021-06-04, 1400/03/14
Registration timing:retrospective
Last update:2021-06-04, 1400/03/14
Update count:0
Registration date
2021-06-04, 1400/03/14
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 0659
Email address
ivfyazd@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
2014-06-22, 1393/04/01
Actual recruitment end date
2016-06-21, 1395/04/01
Trial completion date
2016-06-21, 1395/04/01
Scientific title
Evaluation the effects of Vitamin E and selenium on the expression of nox5 and HSPA2 in astheniteratozoospermia men
Public title
Evaluation the effects of Vitamin E and selenium on the expression of nox5 and HSPA2 in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile men with asthenoteratozoospermia (ATZ) with normal morphology lower than 4% and total motility lower than 40%
Exclusion criteria:
Cases with leukocytospermia (>1×106 WBC/mL)
Oligospermia
Varicocele
Cancer
Endocrine disorders
Genital tract infection
Autoimmune disease
Cryptorchidism
Smoking or alcohol consumption
Patients who received chemotherapy or radiotherapy
Patients who received recent antioxidant intake
Azoospermia
Age
From 20 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random Sampling. The study population is infertile men with teratostenozoospermia. Each participant randomly enters one of the study groups (placebo or treatment ) and will receive two packs of pills in different colors from the doctor who is unaware of their contents. Researchers, impact evaluators and data analysts are also unaware of the assignment of the study group and the record book is in the hands of the doctor until the end of the study.
The treatment group receives a daily supplement of vitamin E (400 IU) in combination of selenium (200μg) and the placebo group receives two caplet of placebo for 3 months. Also, all patients will be followed up by researchers throughout the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants, researchers, outcome evaluators, and data analysts are blind to the intervention until the study is completed.Each participant randomly enters one of the study groups (placebo or under treatment) and will receive two packs of pills in different colors from the doctor, which the doctor is unaware of its content.Researchers, impact evaluators and data analysts are also unaware of the assignment of the study group and the record book is in the hands of the doctor until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences and Health Services
Street address
Safaieh - Timsar Fallahi Street
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
342
Health conditions studied
1
Description of health condition studied
Infertile asthenoteratozoospermia men
ICD-10 code
N46
ICD-10 code description
Diseases of male genital organs
Primary outcomes
1
Description
Sperm concentration
Timepoint
At the beginning of the study (before the intervention) and three months later
Method of measurement
According to WHO 2010 guidelines
2
Description
Sperm motility
Timepoint
At the beginning of the study (before the intervention) and three months later
Method of measurement
According to WHO 2010 guidelines
3
Description
Sperm morphology
Timepoint
At the beginning of the study (before the intervention) and three months later
Method of measurement
Using Papanicolaou staining and and according to WHO 2010 guidelines
4
Description
Sperm viability
Timepoint
At the beginning of the study (before the intervention) and three months later
Method of measurement
Using Eosin Nigrosin staining and according to WHO 2010 guidelines
5
Description
Sperm apoptosis
Timepoint
At the beginning of the study (before the intervention) and three months later
Method of measurement
By flow cytometry and according to WHO 2010 guidelines
6
Description
Sperm protamine deficiency
Timepoint
At the beginning of the study (before the intervention) and three months later
Method of measurement
CMA3 staining and fluorescence microscopy and according to WHO 2010 guidelines
7
Description
Intracellular superoxide anion
Timepoint
At the beginning of the study (before the intervention) and three months later
Method of measurement
By flow cytometry
8
Description
HSPA2 positive sperm
Timepoint
At the beginning of the study (before the intervention) and three months later
Method of measurement
By flow cytometry
9
Description
NOX positive sperm
Timepoint
At the beginning of the study (before the intervention) and three months later
Method of measurement
By flow cytometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment group received a daily supplement of vitamin E (400 IU) in combination of selenium (200μg)
Category
Treatment - Drugs
2
Description
Placebo group: Take two placebo tablets daily, which look similar to vitamin E and selenium in the treated group, for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Research Institute, Infertility Therapy Research Center
Full name of responsible person
Parvin Sabeti
Street address
Safaieh ، Timsar Fallahi Street
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
yazd-rsi@ssu.ac.ir
Web page address
http://web.ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
Shohada Gomnam Boulevard, Professor Hesabi Boulevard
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
yazd-rsi@ssu.ac.ir
Web page address
http://web.ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Sanandaj University of Medical Sciences
Full name of responsible person
Parvin Sabeti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Kurdistan University of Medical Sciences, Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Phone
+98 87 3366 4645
Email
ivfyazd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Parvin Sabeti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Kurdistan University of Medical Sciences, Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Phone
+98 87 3366 4645
Email
ivfyazd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Parvin Sabeti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Kurdistan University of Medical Sciences, Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Phone
+98 87 3366 4645
Email
ivfyazd@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
After printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research work
From where data/document is obtainable
Parvin Sabeti is a member of the faculty of Sanandaj University of Medical Sciences
What processes are involved for a request to access data/document
Parvin Sabeti, Sanandaj University of Medical Sciences, School of Medicine, Department of Anatomy