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IRCT20190714044209N1 IRCT 2020-02-06 The University of Arak Evaluating the Therapeutic Effect of Theophylline and Zinc Sulfate Co-administration in Infertile Men Evaluating the Therapeutic Effect of Theophylline and Zinc Sulfate Co-administration in Infertile Men 2019-12-22 anticipated 120 Complete https://irct.ir/trial/43806 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The drugs selected in this study will not interfere in the normal course of treatment of patients, Randomization description: Simple randomization, Blinding description: Both participants and researchers or evaluators of the outcome are unaware of the allocation of study groups. 3 infertile men. Intervention 1: Intervention group: Theophylline (200 mg/day for 3 months period). Intervention 2: Intervention group: Zink sulfate (220 mg/day for 3 months period). Intervention 3: Intervention group: Theophylline (200 mg/day for 3 months period) and Zink sulfate (220 mg/day for 3 months period) at the same time. Intervention 4: Control group: just placebo for 3 months perid. 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 Because I have not yet entered the practical phase of study
public Atena Sadat Azimi
No. 6313 , At the top of Azimi shop, Haqqani Street
Arak Iran (Islamic Republic of) 3815166315 +98 86 3277 7300 a-azimi@phd.araku.ac.ir Arak University scientific Atena Sadat Azimi
No. 6313 , At the top of Azimi shop, Haqqani Street
Arak Iran (Islamic Republic of) 3815166315 +98 86 3277 7300 a-azimi@phd.araku.ac.ir Arak University Iran (Islamic Republic of) Infertile men who, despite having at least one year of unprotected intercourse, have not had fertility in their spouse. These men will all be married According to WHO criteria, abnormalities in sperm parameters should be observed in at least two sperm samples within 2 weeks. These men will be between the ages of 20 and 50. 20 years 50 years Male Single men Men with varicoceles or any other specific disease Men who have taken a particular drug for the past three months N46 Male infertility Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Theophylline (200 mg/day for 3 months period) Intervention group: Zink sulfate (220 mg/day for 3 months period) Intervention group: Theophylline (200 mg/day for 3 months period) and Zink sulfate (220 mg/day for 3 months period) at the same time Control group: just placebo for 3 months perid Semen analysis. Timepoint: Before intervention. Method of measurement: CASA (Computer-aided sperm analysis) system. Hormones analysis. Timepoint: Before intervention. Method of measurement: ELISA Kit. Malondialdehyde (MDA) level. Timepoint: Before intervention. Method of measurement: ELISA Kit. Total antioxidant capacity (TAC). Timepoint: Before intervention. Method of measurement: ELISA Kit. DNA fragmentation. Timepoint: Before intervention. Method of measurement: SDFA (Sperm DNA Fragmentation Analysis) kit. Levels of inflammatory factors. Timepoint: Before intervention. Method of measurement: ELISA Kit. Sperm viability. Timepoint: Before intervention. Method of measurement: Eosin-Negrosin Staining. Sperm maturation. Timepoint: Before intervention. Method of measurement: Aniline blue staining kit. Investigation of changes in gene expression level. Timepoint: Before intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Protein levels measurement. Timepoint: Before intervention. Method of measurement: Western blot. The University of Arak Approved 2019-08-07 Ethics Committee of Arak University of Medical Sciences No. 6315 Upstairs Azimi shop, Shahid Haghani Street. Arak Markazi Iran (Islamic Republic of)