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The aim of this study is to investigate the impact of co-administration of Pentoxifylline and Zinc sulfate on oxidative stress, apoptosis, and inflammation, sperm capacitation and parameters in infertile men.
This study will be performed as a double-blind randomized clinical trial on idiopathic infertile men (including oligoasthenosospermia, dyspnea, astheno-teratozoospermia, oligo-astheno-teratozoospermia) referred to Shafa Infertility Clinic. Patient satisfaction, non-use of contraceptives, men aged 25 to 43 years and idiopathic infertility according to WHO criteria (World Health, 2010) are our study criteria. A food questionnaire is also taken from them to identify patients. Any medication that may affect sperm production should be discontinued within three months of the study.
Sampling and administration of pentoxifylline and zinc:
Preparation and analysis of semen samples are performed according to WHO 2010 recommendations. Semen samples are prepared by masturbating after a 3 to 5 day abstinence period. Two semen samples from these men, one before and the other after the intervention, are evaluated for basic parameters. For liquefaction, semen samples are incubated for 30 to 60 minutes at 37 ° C. Microscopic tests are performed to evaluate indicators such as sperm concentration in semen, motility and sperm morphology. Objectives and study methods are explained to patients who meet the inclusion criteria. Written consent is then obtained from the candidate. Body mass index (BMI) is assessed for patients. Also, at the beginning of the study, 5 cc of blood is taken from patients to measure reproductive hormones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo group | Experimental | Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily |
|
| pentoxifylline group | Experimental | Intervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily) |
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| Zinc group | Experimental | Intervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily) |
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| pentoxifylline+ zinc group | Experimental | Intervention group 3: received pentoxifylline+ zinc (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily + Zinc Sulfate 220mg Capsules,One time daily ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. Candidates receive two placebo tablets daily |
| Measure | Description | Time Frame |
|---|---|---|
| count of sperm | count of sperm(In per million - with the help of a neobar slide and microscopic observation | One week after starting the medication |
| motility of sperm | motility of sperm: Calculate the percentage of motile sperm using microscopic observation | One week after starting the medication |
| morphology of sperm | Calculate the percentage of sperm with a normal shape with the help of Papanic staining | One week after starting the medication |
| Malon di aldehyd evaluate | Malondialdehyde (nmol/mL), will be measured using related experimental kits | One week after starting the medication |
| ROS evaluate | reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits | One week after starting the medication |
| TAC (Total Antioxidant Capacity) evaluate | total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits | One week after starting the medication |
| FSH hormon | FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit | One week after starting the medication |
| LH hormon |
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| Measure | Description | Time Frame |
|---|---|---|
| caspase 3 expression | expression of caspase 3 gen (in p.c) using real-time PCR and Western blot | 3 months |
| BAX expression | expression of BAX gen(in p.c) using real-time PCR and Western blot |
Inclusion Criteria:
Exclusion Criteria:
men with idiopathic infertility
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35182288 | Derived | Dadgar Z, Shariatzadeh SMA, Mehranjani MS, Kheirolahi A. The therapeutic effect of co-administration of pentoxifylline and zinc in men with idiopathic infertility. Ir J Med Sci. 2023 Feb;192(1):431-439. doi: 10.1007/s11845-022-02931-0. Epub 2022 Feb 19. |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| D015032 | Zinc |
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
|
| Pentoxifylline | Drug | 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. Candidates receive two trental tablets daily |
|
|
| zinc | Drug | 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. Candidates receive one zinc sulfate tablet daily |
|
|
| zinc + pentoxifylline | Drug | 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. Candidates receive two pentoxifylline tablets+ one zinc tablet daily |
|
|
LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit |
| One week after starting the medication |
| Testosteron hormon | testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit | One week after starting the medication |
| TNF α( Tissue necrosis Factor) | TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor will be measured using related experimental kit | One week after starting the medication |
| Interleukin-6 (IL-6) | Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit | One week after starting the medication |
| Sperm DNA Fragmentation Assay(SDFA) | DNA fragmentation will be assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm). | One week after starting the medication |
| 3 months |
| BCL 2 expression | expression of BCL 2 gen (in p.c) using real-time PCR and Western blot | 3 months |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D017967 | Zinc Compounds |