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IRCT20140409017210N2 IRCT 2021-06-04 Yazd University of Medical Sciences Evaluation the effects of Vitamin E and selenium on the expression of nox5 and HSPA2 in infertile men Evaluation the effects of Vitamin E and selenium on the expression of nox5 and HSPA2 in astheniteratozoospermia men 2014-06-22 anticipated 60 Complete https://irct.ir/trial/15880 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Random Sampling. The study population is infertile men with teratostenozoospermia. Each participant randomly enters one of the study groups (placebo or treatment ) and will receive two packs of pills in different colors from the doctor who is unaware of their contents. Researchers, impact evaluators and data analysts are also unaware of the assignment of the study group and the record book is in the hands of the doctor until the end of the study. The treatment group receives a daily supplement of vitamin E (400 IU) in combination of selenium (200μg) and the placebo group receives two caplet of placebo for 3 months. Also, all patients will be followed up by researchers throughout the study, Blinding description: All participants, researchers, outcome evaluators, and data analysts are blind to the intervention until the study is completed.Each participant randomly enters one of the study groups (placebo or under treatment) and will receive two packs of pills in different colors from the doctor, which the doctor is unaware of its content.Researchers, impact evaluators and data analysts are also unaware of the assignment of the study group and the record book is in the hands of the doctor until the end of the study. N/A Infertile asthenoteratozoospermia men. Intervention 1: Intervention group: Treatment group received a daily supplement of vitamin E (400 IU) in combination of selenium (200μg). Intervention 2: Placebo group: Take two placebo tablets daily, which look similar to vitamin E and selenium in the treated group, for three months. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: After printing the results To whom: Researchers working in academic and scientific institutions Conditions: For research work Where to obtain: Parvin Sabeti is a member of the faculty of Sanandaj University of Medical Sciences How to obtain: Parvin Sabeti, Sanandaj University of Medical Sciences, School of Medicine, Department of Anatomy Comments:
public Parvin Sabeti
Kurdistan University of Medical Sciences, Pasdaran St.
Sanandaj Iran (Islamic Republic of) 6617913446 +98 87 3366 4645 ivfyazd@yahoo.com Sanandaj University of Medical Sciences scientific Parvin Sabeti
Kurdistan University of Medical Sciences, Pasdaran St.
Sanandaj Iran (Islamic Republic of) 6617913446 +98 87 3366 4645 ivfyazd@yahoo.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Infertile men with asthenoteratozoospermia (ATZ) with normal morphology lower than 4% and total motility lower than 40% 20 years 55 years Male Cases with leukocytospermia (>1×106 WBC/mL) Oligospermia Varicocele Cancer Endocrine disorders Genital tract infection Autoimmune disease Cryptorchidism Smoking or alcohol consumption Patients who received chemotherapy or radiotherapy Patients who received recent antioxidant intake Azoospermia N46 Diseases of male genital organs Treatment - Drugs Placebo Intervention group: Treatment group received a daily supplement of vitamin E (400 IU) in combination of selenium (200μg) Placebo group: Take two placebo tablets daily, which look similar to vitamin E and selenium in the treated group, for three months. Sperm concentration. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: According to WHO 2010 guidelines. Sperm motility. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: According to WHO 2010 guidelines. Sperm morphology. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: Using Papanicolaou staining and and according to WHO 2010 guidelines. Sperm viability. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: Using Eosin Nigrosin staining and according to WHO 2010 guidelines. Sperm apoptosis. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: By flow cytometry and according to WHO 2010 guidelines. Sperm protamine deficiency. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: CMA3 staining and fluorescence microscopy and according to WHO 2010 guidelines. Intracellular superoxide anion. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: By flow cytometry. HSPA2 positive sperm. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: By flow cytometry. NOX positive sperm. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: By flow cytometry. Yazd University of Medical Sciences Approved 2014-09-16 Ethics committee of Shahid Sadoughi University of Medical Sciences and Health Services Safaieh - Timsar Fallahi Street Yazd Yazd Iran (Islamic Republic of)