1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
The effects of lycopene supplement on the Spermatogram and seminal total antioxidant capacity, Malondialdehyde, Glutathione Peroxidase and depression in infertile men
Protocol summary
Study aim
Effect of lycopene supplementation on spermatogram, antioxidant capacity, malondialdehyde and glutathione peroxidase in seminal fluid and depression in infertile men
Design
In this study, 44 infertile women referred to Isfahan Royan Infertility Center who are eligible for inclusion criteria are selected. Participants are randomly assigned to two intervention and control groups.
Settings and conduct
This double-blind clinical trial will be conducted at the Isfahan Royan Infertility Center. At first, people fill in the demographic questionnaire and they will be asked to deliver the sperm samples to the laboratory according to the WHO criteria, and then the necessary tests will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:: 1. Primary infertility according to WHO criteria. 2. All male infertile male patients with varicocele other than those who meet exit criteria. Non-inclusion criteria: 1-testicular atrophy 2. Hormonal disorders such as gonadotropins, testosterone and prolactin 3-
ejaculatory disorder 4. Anatomical disorders of the duct such as hypospadias 5. Urinary tract infection 6. Drug use in the last 6 months 7-azoospermia 8. People who use anticoagulant drugs. 9. Use of antioxidant supplements 10-Smokers
Intervention groups
In this study, the intervention group received 25 mg of lycopene, and the control group received 25 mg of placebo or plasma.
Main outcome variables
Spermogram, antioxidant capacity, malondialdehyde, glutathione peroxidase and depression
General information
Reason for update Acronym
IRCT registration information
IRCT registration number: IRCT20171105037249N1 Registration date: 2018-01-20, 1396/10/30
Registration timing: retrospective
Last update: 2018-01-20, 1396/10/30 Update count: 0
Registration date 2018-01-20, 1396/10/30 Registrant information
Name
Mehran Nouri
Name of organization / entity
Isfahan University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 11 3244 2326 Email address
[email protected] Recruitment status
Recruitment complete Funding source
Isfahan University of Medical Sciences, Isfahan Royan Center and Pora Teb Co.
Expected recruitment start date 2017-11-22, 1396/09/01
Expected recruitment end date 2018-01-20, 1396/10/30 Actual recruitment start date
empty
Actual recruitment end date
2 empty
Trial completion date empty
Scientific title
The effects of lycopene supplement on the
Spermatogram and seminal total antioxidant capacity, Malondialdehyde, Glutathione Peroxidase and depression in infertile men
Public title
The effect of Lycopene on Infertility Purpose
Treatment
Inclusion/Exclusion criteria Inclusion criteria:
Primary infertility based on WHO criteria All male infertile male patients with varicoceles other than those who meet exit criteria.
Exclusion criteria:
Testicular atrophy Hormonal disorders such as gonadotropins, testosterone and prolactin Ejaculation disorder Anatomical abnormalities such as hypospadias Urinary tract infection Drug in the last 6 months
Azoospermia People who use anticoagulant drugs. Use of antioxidant supplements Being a smoker
Age
No age limit Gender
Male Phase
3
Groups that have been masked Participant
Care provider Outcome assessor Sample size
Target sample size: 44
Randomization (investigator's opinion) Randomized
Randomization description
In this method, we use a simple randomization model (random number table) and each referral will be in the intervention or control group.
Blinding (investigator's opinion) Double blinded
Blinding description
In this study, the patients and the physician and those who will perform the tests will not be aware of the fact that the person is using lycopene supplement or placebo, and only the investigator and data analyst will know how to blind.
Placebo Used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Street address
Isfahan-Azadi Square-Hezar Jereyb St.
City Isfahan Province
Isfehan Postal code
81746-73461 Approval date
2017-08-06, 1396/05/15
Ethics committee reference number IR.MUI.REC.1396.3.325
Health conditions studied
1
Description of health condition studied Infertile
ICD-10 code N46.1
ICD-10 code description Oligospermia
Primary outcomes
1
Description
Concentration, number and sperm movement Timepoint
The beginning and the end of the study Method of measurement
Spermogram
Secondary outcomes
1
Description
malondialdehyde, total antioxidant capacity, glutathione peroxidase
Timepoint
The beginning and the end of the study Method of measurement
Biochemical
2
Description Depression Timepoint
The beginning and the end of the study Method of measurement
3 DASS questionnaire
Intervention groups
1
Description
The intervention group receives 25 milligrams of lycopene from 21 Cent. Company once a day and for three months.
Category
Treatment - Drugs
2
Description
Control group: The control group will take 25 mg (starch) once a day for 3 months.
Category Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center Isfahan Royan Center
Full name of responsible person Dr.Mohammad hossein Nasr Esfahani Street address
Esfahan, Bolshay Meher Square, Salman Fars Ave (Eager Second), Corner of Behesht Street, No. 23 City
Isfahan Province
Isfehan Postal code
8158858151 Phone
+98 31 3267 0030 Fax
+98 31 3267 9082 Email
[email protected] Web page address
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Esfahan University of Medical Sciences Full name of responsible person
Dr.Reza Amani Street address
Isfahan, Azadi Square, Faculty of Nutrition and Food Sciences
City Isfahan Province
Isfehan Postal code
81746-73461 Phone
+98 31 3792 3175 Email
[email protected] Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences Full name of responsible person
Mehran Nouri Position
Masters Latest degree
Bachelor
Other areas of specialty/work Nutrition
Street address
Isfahan, Azadi Square, School of Nutrition City
Isfahan Province
Isfehan Postal code
81746-73461 Phone
+98 31 3792 3175 Fax
+98 31 3668 1378 Email
[email protected] Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences Full name of responsible person
4 Reza Amani
Position
Ph.D. Nutrition Latest degree
Ph.D.
Other areas of specialty/work Nutrition
Street address
Isfahan, Azadi Square, School of Nutrition City
Isfahan Province
Isfehan Postal code
81746-73461 Phone
+98 31 3792 3175 Fax
+98 31 3668 1378 Email
[email protected] Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences Full name of responsible person
Mehran Nouri Position
Masters / Student Latest degree
Bachelor
Other areas of specialty/work Nutrition
Street address
Isfahan, Azadi Square, School of Nutrition City
Isfahan Province
Isfehan Postal code
81746-73461 Phone
+98 31 3792 3175 Fax
+98 31 3668 1378 Email
[email protected] 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
Yes - There is 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
Yes - There is a plan to make this available Title and more details about the data/document
Information about the underlying implications will be shared.
When the data will become available and for how long
One year after the document was printed To whom data/document is available
All people in this area can apply for documentation.
Under which criteria data/document could be used Individuals can take action by e-mail to access the documentation.
From where data/document is obtainable Individuals can take action by e-mail to access the documentation.
What processes are involved for a request to access data/document
People can access the documents in the file if they are in charge of the email designer.
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