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IRCT20190406043177N1 IRCT 2019-08-21 Royan Institute Effect of alpha lipoic acid on male infertility The effect of alpha lipoic acid on sperm parameters, DNA integrity and oxidative stress in infertile men with increased level of sperm DNA damage 2018-06-22 anticipated 80 Complete https://irct.ir/trial/39346 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization, Blinding description: The drug and placebo package was similar and was given to patients by the pharmacist according to the numbers in randomization. The patient himself did not have any information on the use of the medicine or the placebo. The laboratory expert and researcher only analyzed the samples by the numbers. 3 Male Infertility. Intervention 1: Control group: 3 month usage of placebo. Intervention 2: Intervention group: 3 month usage of 2 Cap. 300 mg alpha lipoic acid Bd before Breakfast and Lunch. 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 based on the idea of Ethic in Medicine Committee
public Prof. Mohammad Hossein Nasr Esfahani
No.371, Allikhani Aleey, Mehr St., Salman Farsi Ave., Isfahan, Iran
esfahan Iran (Islamic Republic of) 8158968433 +98 31 9501 5682 mh.nasr-esfahani@royaninstitute.org Royan Institute scientific Prof. Mohammad Hossein Nasr Esfahani
No.371, Allikhani Aleey, Mehr St., Salman Farsi Ave., Isfahan, Iran
Esfahan Iran (Islamic Republic of) 8158968433 +98 31 9501 5687 mh.nasr-esfahani@royaninstitute.org Royan Institute Iran (Islamic Republic of) Infertile men with normal sperm parameters and high levels of DNA fragmentation (SCSA>30 , TUNEL>15) Infertile men with abnormal sperm parameters and high levels of DNA fragmentation (SCSA>30 , TUNEL>15) no limit no limit Male Varicocele Leukocytospermia cancer and chemotherapy cytotoxic medicine usage N46 Male infertility Placebo Treatment - Drugs Control group: 3 month usage of placebo Intervention group: 3 month usage of 2 Cap. 300 mg alpha lipoic acid Bd before Breakfast and Lunch DNA Damage. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow cytometry device. Fluorescence and optic microscope. Sperm motility. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: CASA Device. Sperm morphology. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: microscope. Sperm count. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: neobar lam. Sperm vitality. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: microscope. Lipid peroxidation (MDA level). Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: spectrophotometer. Mitochondrial membrane potential. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow Cytometry device. TAC. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: ELISA Reader. SOD. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: ELISA Reader. GPX. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: ELISA Reader. ROS. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow Cytometry device. Chromatin evaluation. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow Cytometry device. Fertilization Rate. Timepoint: After Treatment. Method of measurement: Patient Flow up and Fertility Tests. Royan Institute Approved 2019-01-16 Ethics committee of Royan Institute Royan Institute, Hafez St., Banihashem St, Tehran Tehran Tehran Iran (Islamic Republic of)