Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Men with idiopathic infertility
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Intervention groups
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Intervention group: the group receiving probiotic (500 mg daily)
Control group: placebo group
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Main outcome variables
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Sperm parameters, inflammatory factors, oxidative stress indices and sex hormones
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2018-01-26, 1396/11/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-11-22, 1396/09/01
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Expected recruitment end date
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2018-03-20, 1396/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Probiotic supplementation in infertile men
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 45 years old
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Gender
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Male
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-11-21, 1396/08/30
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Ethics committee reference number
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IR.AJUMS.REC.1396.621
Health conditions studied
1
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Description of health condition studied
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Asthenospermia
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ICD-10 code
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N46
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ICD-10 code description
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Male infertility
Primary outcomes
1
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Description
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Sperm parameters
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Spermatogram
2
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Description
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Inflammatory factors
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Eliza
3
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Description
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Antioxidant indices
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Timepoint
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Before intervention and after intervention
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Method of measurement
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Eliza
4
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Description
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Sex hormones
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Timepoint
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Before intervention and after intervention
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Method of measurement
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Eliza
5
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Description
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Sleep quality
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Timepoint
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Before intervention and after intervention
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Method of measurement
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Petersburg’s sleep quality questionnaire
Intervention groups
1
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Description
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Intervention group: Probitic, 500 mg per daily
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Category
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Treatment - Drugs
2
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Description
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Control group: Plasebo
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Data on primary and secondary outcomes will be published.
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When the data will become available and for how long
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After completing the study and analyzing the data
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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There is no objection to the use of data provided the source of the resource.
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From where data/document is obtainable
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IRCT site
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What processes are involved for a request to access data/document
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Six months after the study
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Comments
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