Protocol summary

Study aim
Comparison of the effect of multiple dietary supplements on the quality of sperm parameters of elite and amateur football players
Design
football training
Settings and conduct
university
Participants/Inclusion and exclusion criteria
Football player
Intervention groups
supplement
Main outcome variables
sperm factors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211103052956N1
Registration date: 2021-11-10, 1400/08/19
Registration timing: retrospective

Last update: 2021-11-10, 1400/08/19
Update count: 0
Registration date
2021-11-10, 1400/08/19
Registrant information
Name
Saeid Rostami
Name of organization / entity
Ragheb Isfahani higher education institute
Country
Iran (Islamic Republic of)
Phone
+98 31 3368 9040
Email address
srostami.20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-27, 1400/08/05
Expected recruitment end date
2021-10-27, 1400/08/05
Actual recruitment start date
2021-10-27, 1400/08/05
Actual recruitment end date
2021-10-27, 1400/08/05
Trial completion date
2021-11-26, 1400/09/05
Scientific title
Comparison of the effect of multiple dietary supplements on the quality of sperm parameters of elite and amateur football players
Public title
Comparison of the effect of multiple dietary supplements on the quality of sperm parameters of elite and amateur football players
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
be athlete
Exclusion criteria:
Age
From 22 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
---
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in biomedical research
Street address
Islamic Azad University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
11111111111
Approval date
2021-01-24, 1399/11/05
Ethics committee reference number
IR.IAU.KHUISF.REC.1399.260

Health conditions studied

1

Description of health condition studied
---
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sperm factors
Timepoint
pre and post test
Method of measurement
spermatogenesis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: dietary supplement
Category
Other

2

Description
Control group: starch tablet
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
---
Full name of responsible person
---
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 4522 9250
Email
srostami.20@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ragheb Isfahani higher education institute
Full name of responsible person
Saeid Rostami
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 4522 9250
Email
srostami.20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ragheb Isfahani higher education institute
Proportion provided by this source
100
Public or private sector
Private
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
Ragheb Isfahani higher education institute
Full name of responsible person
Saeid Rostami
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 4522 9250
Email
srostami.20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ragheb Isfahani higher education institute
Full name of responsible person
Saeid Rostami
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 4522 9250
Email
srostami.20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ragheb Isfahani higher education institute
Full name of responsible person
Saeid Rostami
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 4522 9250
Email
srostami.20@gmail.com

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
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Comparison of the effect of multiple dietary supplements on the quality of sperm parameters of elite and amateur football players
When the data will become available and for how long
september- november 2021
To whom data/document is available
researchers and student
Under which criteria data/document could be used
after submssion of article
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document
by email
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