Protocol summary
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Study aim
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Determination of the effect of selenium-enriched yeast on sperm parameters, serum androgens, sexual function, and quality of sexual life in oligoasthenoteratozoospermia infertile men in comparison with placebo
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Design
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The controlled clinical trial, with two parallel arms, triple-blind, randomized, phase 3 on 80 patients. RAS (Random Allocation Software) will be used for randomization.
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Settings and conduct
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The eligible infertile men referred to infertility clinics affiliated to Tabriz University of Medical Sciences and their spouses will be visited first by a gynecologist and urologist. Participants will be randomly assigned to two groups of selenium-enriched yeast supplements and placebos using a random block method with an allocation ratio of 1:1, which are exactly the same in shape, color and weight. The researcher, participant, data analyst, and outcome assessor will be blind.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: An infertile married man with idiopathic oligoasthenoteratozoospermia for at least one year, Age 20 to 40 years, No problem in wife fertility, Non-addiction to alcohol and substance abuse. Exclusion criteria: Azoospermia, Infectious disease and anatomical abnormalities of the genital tract, Varicocele-related infertility, pelvic surgeries or need to do so, cancers, and other chronic diseases,
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Intervention groups
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The first group will receive one 250 mg capsule of selenium-enriched yeast containing 200 micrograms of organic selenium daily and taken with food for 3 months.
The second group will receive 250 mg placebo capsules containing yeast. The placebo will be taken with the same prescription as the selenium capsule.
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Main outcome variables
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Changes in semen parameters (number, morphology, motility); Serum levels of androgens; Mean sexual function score; Quality of sex life score after intervention
General information
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Reason for update
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1- Due to the fact that the number of smokers infertile males is high and including the criterion of non-smoking will cause the loss of a high percentage of samples, according to the research group, it was decided to remove this criterion and instead stratification of study groups based on this criterion. Stratification will be done so that the number of smokers in both study groups is equal and its confounding effect is eliminated.
2- Considering that due to the retirement of the esteemed urologist colleague, the sampling status of the project is suspended and fortunately in recent days he has entrusted the cooperation in his project to another urologist who is an assistant professor at the university and considering accepting cooperation from him, sampling will be started in April. Therefore, please the start of sampling be modified to April 10, 1401.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20131009014957N11
Registration date:
2021-02-11, 1399/11/23
Registration timing:
prospective
Last update:
2022-03-16, 1400/12/25
Update count:
1
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Registration date
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2021-02-11, 1399/11/23
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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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2022-04-08, 1401/01/19
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Expected recruitment end date
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2022-10-11, 1401/07/19
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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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The effect of supplementation with selenium-enriched saccharomyces cervisiae yeast on sperm parameters, serum levels of androgens, sexual function, and quality of sexual life in oligoasthenoteratozoosperm infertile men: A triple-blind randomized controlled clinical trial
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Public title
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The effect of supplementation with organic selenium on sperm parameters, serum levels of androgens, sexual function, and quality of sexual life in infertile men
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
An infertile married man with idiopathic oligoasthenoteratozoosperm for at least one year
Age 20 to 40 years
No problem in wife fertility
Non-addiction to alcohol and substance abuse
Exclusion criteria:
َAzospermia
Infectious disease and anatomical abnormalities of the genital tract
Varicocele-related infertility
History of pelvic surgeries or need to do so
Cancer, liver and gallbladder diseases, diabetes, thyroid disorders, kidney failure, uncontrolled blood pressure, cerebral hemorrhage, retinal hemorrhage, unilateral testicular atrophy
Abnormal karyotype
History of receiving chemotherapy drugs, corticosteroids, anticoagulants, testosterone, anti-androgens
Taking any chemical or herbal medicine specific to infertility during the project and the previous three months
BMI>=30
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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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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible individuals will be assigned into two groups of selenium-enriched yeast supplements or placebo using a randomized blocking method with the 4 and 6 sized blocks and 1: 1 allocation ratio. The allocation sequence will be generated by the researcher through RAS (Random Allocation Software). The medicines and placebo will be placed in a Flacons. Falcons will be assigned numbers from 1 to 80. They will be the same shaped, closed, opaque, and contain 90 capsules, and their preparation will be done based on the sequence allocation by the person not involved in the research.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The first group will receive one 250 mg capsule of selenium-enriched yeast (containing 200 micrograms of selenium) daily, and the second group will receive a placebo capsule (containing 250 mg of yeast) that will be the same shape, color, and weight. Participants, the principal investigator, health care personnel, those evaluating the outcome, the Data Safety and Monitoring Committee, and those drafting the article will be blinded.
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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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2020-11-23, 1399/09/03
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Ethics committee reference number
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IR.TBZMED.REC.1399.805
Health conditions studied
1
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Description of health condition studied
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Oligoasthenoteratozoospermia
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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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Semen parameters (number, morphology, motility)
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Timepoint
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Baseline and 12 weeks after the intervention
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Method of measurement
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To calculate the number of live sperm, morphology and motility, a light microscope with a magnification of 1000× will be used.
2
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Description
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Serum levels of androgens (total testosterone, free testosterone and dehydroepiandrosterone
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Timepoint
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Baseline and 12 weeks after the intervention
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Method of measurement
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Using ELISA method by monobind kits
3
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Description
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Sexual function score
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Timepoint
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Baseline and 12 weeks after the intervention
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Method of measurement
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BSFI: Brief Sexual Function Inventory
4
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Description
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Sex quality of life score
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Timepoint
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Baseline and 12 weeks after the intervention
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Method of measurement
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Sexual Quality of Life-M: SQOL-M
Secondary outcomes
1
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Description
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Pregnancy rate
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Timepoint
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12 weeks after the intervention
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Method of measurement
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Follow-up for up to two months after the intervention and quantitative Beta-hCG testing if necessary
2
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Description
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Side effects
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Timepoint
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During and after the intervention
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Method of measurement
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Questionnaire
3
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Description
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Satisfaction with medication
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Timepoint
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During and after the intervention
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Method of measurement
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Satisfaction rate questionnaire
Intervention groups
1
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Description
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Intervention group: They will take one 250 mg S.cerevisiae yeast capsule containing 200 micrograms of organic selenium daily orally with meals for 3 months. Organic selenium will be produced at the Nutrition Research Center.
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Category
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Treatment - Drugs
2
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Description
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Control group: One 250 mg oral capsule containing S. cerevisiae yeast daily for 3 months, which will be similar in shape, color, and weight to selenium-containing capsules and will be produced at the Nutrition Research Center.
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Category
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Placebo
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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Tabriz 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data on the main outcome will be published
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When the data will become available and for how long
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Six months after printing the results
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To whom data/document is available
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Researchers at institutions have access to data
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Under which criteria data/document could be used
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In order to help scientific progress in the field of research
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From where data/document is obtainable
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farshbafa@tbzmed.ac.ir
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What processes are involved for a request to access data/document
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Scientific approval of the applicant by Tabriz University of Medical Sciences
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Comments
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