Evaluation The Efficacy Of Probiotic Supplement On Sperm Parameters, Sex Hormones, Oxidative Stress Index and Inflammatory Factors In Men With Idiopathic Infertility: Randomized Double Blind Clinical Trial
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
The sleep quality questionnaire was filled out for participants but was not recorded at the time of registration on the IRCT site due to negligence.
The sleep quality questionnaire was filled out for participants but was not recorded at the time of registration on the IRCT site due to negligence.
empty
پرسشنامه کیفیت خواب برای افراد شرکت کننده پر شده بود ولی در زمان ثبت در سایت بخاطر بی توجهی ثبت نشده بود.
پرسشنامه کیفیت خواب برای افراد شرکت کننده پر شده بود ولی در زمان ثبت در سایت بخاطر بی توجهی ثبت نشده بود.
Primary outcomes
#1
empty
Sleep quality
Sleep quality
empty
کیفیت خواب
کیفیت خواب
empty
Before intervention and after intervention
Before intervention and after intervention
empty
قبل از مداخله و بعد از مداخله
قبل از مداخله و بعد از مداخله
empty
Petersburg’s sleep quality questionnaire
Petersburg’s sleep quality questionnaire
empty
پرسشنامه کیفیت خواب پیترزبورگ
پرسشنامه کیفیت خواب پیترزبورگ
Protocol summary
Study aim
The determination of the volume of ejaculation, the number of live sperm, the total sperm count, the sperm concentration, the percentage of sperm motility, the sperm count with normal morphology in the cement fluid, and the inflammatory factors including: C reactive protein (CRP) and alpha-Tumor necrosis factor (TNFα) and Antioxidant factors including total antioxidant capacity (TAC) and malondialdehyde (MDA) concentration in plasma and seminal fluid and sex hormones including: testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin hormone
Design
In this study 50 idiopathic infertile men who are eligible for inclusion in the study and referred to the Urology Department of Imam Khomeini Hospital of Ahwaz Jundishapur University of Medical Sciences, Ahwaz, Iran for the treatment of infertility are selected. Participants are randomly assigned to two intervention and control groups and each participant is assigned a code.
Settings and conduct
This study is a randomized double blind clinical trial. Idiopathic infertile men who are referred to the Urology Department of Imam Khomeini Hospital in Ahvaz, Jundishapur University of Medical Sciences, are enrolled in by the Urology Specialist. Then, 50 patients were selected and randomly divided into intervention and control groups. In this study, the investigator and the patient will be blinded to drugs and placebo.
Participants/Inclusion and exclusion criteria
Men with idiopathic infertility
Intervention groups
Intervention group: the group receiving probiotic (500 mg daily)
Control group: placebo group
Main outcome variables
Sperm parameters, inflammatory factors, oxidative stress indices and sex hormones
General information
Reason for update
The sleep quality questionnaire was filled out for participants but was not recorded at the time of registration on the IRCT site due to negligence.
Acronym
IRCT registration information
IRCT registration number:IRCT20141025019669N7
Registration date:2018-01-26, 1396/11/06
Registration timing:registered_while_recruiting
Last update:2020-04-14, 1399/01/26
Update count:1
Registration date
2018-01-26, 1396/11/06
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
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
Evaluation The Efficacy Of Probiotic Supplement On Sperm Parameters, Sex Hormones, Oxidative Stress Index and Inflammatory Factors In Men With Idiopathic Infertility: Randomized Double Blind Clinical Trial
Public title
Probiotic supplementation in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate in the study
No conception after 12 months intercourse without any contraception)
Idiopathic asthenospermia according to World Health Organization criteria
Normal levels of gonadotropins, testosterone and prolactin of serum
Exclusion criteria:
Any infection in genitourinary (GU) tract
Any anatomical abnormality in GU tract
Contact with pesticides, heavy metals and solvents
Consumption of antioxidant supplements during last 3 months
Age
From 20 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are randomly divided into two groups, intervention and control groups, using randomized distribution method. In this study, the patient and researcher are blinded to medicine and placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jondishapur University Of Medical Sciences
Street address
Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
IR.AJUMS.REC.1396.621
Health conditions studied
1
Description of health condition studied
Asthenospermia
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Sperm parameters
Timepoint
Before the intervention and after the intervention
Method of measurement
Spermatogram
2
Description
Inflammatory factors
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
3
Description
Antioxidant indices
Timepoint
Before intervention and after intervention
Method of measurement
Eliza
4
Description
Sex hormones
Timepoint
Before intervention and after intervention
Method of measurement
Eliza
5
Description
Sleep quality
Timepoint
Before intervention and after intervention
Method of measurement
Petersburg’s sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Probitic, 500 mg per daily
Category
Treatment - Drugs
2
Description
Control group: Plasebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Clinic, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Bizhan Helli
Street address
Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 1373 8254
Email
bizhanhelli@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Bizhan Helli
Street address
Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3731 4528
Email
bizhanhelli@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Bizhan Helli
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 1373 8254
Email
bizhanhelli@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Bizhan Helli
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jondishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 1373 8254
Email
bizhanhelli@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Bizhan Helli
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jondishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 1373 8254
Email
bizhanhelli@yahoo.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
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
Data on primary and secondary outcomes will be published.
When the data will become available and for how long
After completing the study and analyzing the data
To whom data/document is available
All researchers
Under which criteria data/document could be used
There is no objection to the use of data provided the source of the resource.
From where data/document is obtainable
IRCT site
What processes are involved for a request to access data/document