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IRCT20150420021869N5 IRCT 2021-10-14 Esfahan University of Medical Sciences The effect of probiotic and antioxidant use on the semen parameters A comparative study of probiotic and antioxidant use on the improvement of semen parameters in men with primary idiopathic infertility: a randomized clinical trial 2021-09-23 anticipated 102 Complete https://irct.ir/trial/58570 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are randomly assigned to 3 control and intervention groups (probiotics, antioxidants, and placebo) by random allocation software in individual units. Block randomization will be used with a block size of 6. Sealed envelopes containing a number attributed to each intervention group will be used. The patient and the practitioner are blinded to the intervention received, Blinding description: This study is a triple blind study in which the participants and the clinical caregiver and the analyzer are blind and patient group are selected by random allocation software. Randomly assigned to the case or control group (probiotics, antioxidants, and placebo). Then, if he is in any group, he will receive a drug that is appropriate for the group, and all three drugs are similar in shape. But patients and caregivers do not know which medication or placebo they received, and outcome assessors do not know the participants and record their findings based on patient numbers. 3 infertility. Intervention 1: Intervention group: Intervention group: In this group, patients receive one Familact capsule containing 500 mg of synbiotics made by Zist takhmir Pharmaceutical Company for 3 months. Intervention 2: Intervention group: In this group, they receive one sperigen capsule containing antioxidants made by Hayat Daru Iran Company daily for 3 months. Intervention 3: Control group: In this group, patients receive one capsule daily similar to the intervention group without effective substance for 3 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Farshad Gholipour
Mardavij
Isfahan Iran (Islamic Republic of) 8168814193 +98 31 3669 7898 farshad.gholipoor@gmail.com Esfahan University of Medical Sciences scientific Farshad Gholipour
Hezar jarib street
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 gholipour@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Men with primary idiopathic infertility Age 18 to 45 years 18 years 45 years Male Pyospermia History of testicular surgery History of chemotherapy or radiotherapy smoking History and current use of drugs that affect spermatogenesis such as tamoxifen, hcg, cytotoxic drugs such as immunosuppressants, anticonvulsants, androgens History of sexually transmitted diseases Epididymitis and orchitis Testicular trauma Prostatitis Reluctance to participate in the study Chromosomal abnormalities Pregnancy event during the study History of testicular torsion N46 Male infertility Treatment - Drugs Treatment - Drugs Placebo Intervention group: Intervention group: In this group, patients receive one Familact capsule containing 500 mg of synbiotics made by Zist takhmir Pharmaceutical Company for 3 months Intervention group: In this group, they receive one sperigen capsule containing antioxidants made by Hayat Daru Iran Company daily for 3 months. Control group: In this group, patients receive one capsule daily similar to the intervention group without effective substance for 3 months. Seminal fluid volume. Timepoint: before intervention and 3 months after intervention. Method of measurement: semen analysis. Sperm count. Timepoint: before intervention and 3 months after intervention. Method of measurement: semen analysis. Sperm concentration. Timepoint: before intervention and 3 months after intervention. Method of measurement: semen analysis. Sperm motility. Timepoint: before intervention and 3 months after intervention. Method of measurement: semen analysis. Sperm morphology. Timepoint: before intervention and 3 months after intervention. Method of measurement: semen analysis. DNA Fragmentation Index. Timepoint: before intervention and 3 months after intervention. Method of measurement: semen analysis. Esfahan University of Medical Sciences Approved 2021-09-04 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)