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Study aim
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The aim of this study is to investigate the impact of co-administration of Theophylline and Zinc sulfate on oxidative stress, apoptosis, and inflammation, sperm capacitation and parameters in infertile men.
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Design
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Clinical trial with placebo-control group, parallel groups, double-blind, randomized
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Settings and conduct
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This study will perform on infertile men referred to Rastak infertility treatment center in Sina hospital (Markazi Province-Arak city).
In this study Both participants and researchers or evaluators of the outcome are unaware of the allocation of study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse.
These men will all be married
These men will be between the ages of 20 and 50.
According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks.
Exclusion criteria:
Single men
Men with varicocele or any other specific disease
Men who have taken a particular drug for the past three months
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Intervention groups
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.1. Control group: they take placebo for 3 months.
2.They take Theophylline (200 mg/day) for 3 months.
3. They take zinc (zinc sulfate) (220 mg/day) for 3 months.
4. They take Theophylline (200 mg daily) and Zinc (Zinc sulfate) (220 mg daily) for 3 months.
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Main outcome variables
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Semen analysis and sperm parameters (Spermogram;) Levels of LH, FSH and Testosterone; Malondialdehyde Level; TNF-α and Interleukin 10; DNA Fragmentation; Sperm viability; Total antioxidant level of semen; Expression of Caspase 3, BAX, BCL2 genes; Caspase-3, BAX, BCL2 proteins; Sperm maturation; Evaluation of sperm capacitation
All of the aforementioned analyzes were measured in two stages before and after the study.