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IRCT20131009014957N11 IRCT 2021-02-11 Tabriz University of Medical Sciences The effect of supplementation with organic selenium on sperm parameters, serum levels of androgens, sexual function, and quality of sexual life in infertile men 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 2022-04-08 anticipated 80 Complete https://irct.ir/trial/53937 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 3 Oligoasthenoteratozoospermia. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Data on the main outcome will be published When: Six months after printing the results To whom: Researchers at institutions have access to data Conditions: In order to help scientific progress in the field of research Where to obtain: farshbafa@tbzmed.ac.ir How to obtain: Scientific approval of the applicant by Tabriz University of Medical Sciences Comments:
public Tabriz University of Medical Sciences
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2295 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Alireza Ostadrahimi
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2295 ostadrahimi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 20 years 45 years Male َ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 N46 Male infertility Treatment - Drugs Placebo 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. 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. Semen parameters (number, morphology, motility). Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: To calculate the number of live sperm, morphology and motility, a light microscope with a magnification of 1000× will be used. Serum levels of androgens (total testosterone, free testosterone and dehydroepiandrosterone. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using ELISA method by monobind kits. Sexual function score. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: BSFI: Brief Sexual Function Inventory. Sex quality of life score. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Sexual Quality of Life-M: SQOL-M. Pregnancy rate. Timepoint: 12 weeks after the intervention. Method of measurement: Follow-up for up to two months after the intervention and quantitative Beta-hCG testing if necessary. Side effects. Timepoint: During and after the intervention. Method of measurement: Questionnaire. Satisfaction with medication. Timepoint: During and after the intervention. Method of measurement: Satisfaction rate questionnaire. Tabriz University of Medical Sciences Approved 2020-11-23 Ethics committee of TabrizUniversity of Medical Sciences . Vice Chancellor for Research and Technology,Golgasht St Tabriz East Azarbaijan Iran (Islamic Republic of)