The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc in Men With Idiopathic Asthenozoospermia

Study Overview
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Brief Summary
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The aim of this study was to investigate the therapeutic effect of co-administration of pentoxifylline and zinc on sperm apoptosis in men with idiopathic infertility

Detailed Description
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This study is being performed as a double-blind randomized clinical trial on idiopathic infertile men referred to the infertility clinic of Shafa 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. Any medication that may affect the course of spermatogenesis should be discontinued during the study. Semen samples are taken from patients (before and after interventions) and apoptosis tests are performed on semen samples.

Official Title
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The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc on Semen Parameters, Reproductive Hormones, DNA Fragmentation, and Some Biochemical, and Inflammatory Parameters in Men With Idiopathic Infertility

Conditions
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Men Infertility

Intervention / Treatment
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* Drug: Zinc Sulfate 220 mg Capsules
* Drug: Pentoxifylline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infertile men have had at least one year of unprotected intercourse infertility asthenozoospermia Exclusion Criteria: Men with varicocele Hypersensitivity to pentoxifylline & zinc, pelvic organic pathologies congenital adrenal hyperplasia thyroid dysfunction Cushing's syndrome hyper prolactinemia androgen secreting neoplasia severe hepatic pancreatitis kidney diseases gallbladder diseases Patients with alcohol consumption Patients who use cigarettes and drugs

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pentoxifylline group<br>Group 1: Patients receiving pentoxifylline (TRENTAL 400 mg tablets, OSPS; 400 mg, twice daily) Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. These volunteers receive two pentoxifylline tablets(400 mg) daily for 3 month, (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily) Other names: Trental | Drug: Pentoxifylline<br>* Oral use of pentoxifylline is effective in treating cardiovascular disease, cerebrovascular disease, and other conditions associated with local circulatory disorders. Pentoxifylline affects blood viscosity. Infertile men with asthenospermia receive 400 mg pentoxifylline tablets for 3 months<br>* Other names: Trental;|
| Experimental: Zinc Sulfate group<br>Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. Candidates receive one zinc sulfate tablet(229 mg) daily for 3 month,(Zinc Sulfate 220mg Capsules) Other Names: zinc sulfate | Drug: Zinc Sulfate 220 mg Capsules<br>* Zinc is an element that is involved in the activity of antioxidant enzymes. For example, the superoxide dismutase needs copper and zinc to function properly. Infertile men with asthenospermia receive 220 mg zinc sulfate tablets for 3 months<br>* Other names: zinc;|
| Experimental: pentoxifylline+ zinc group<br>Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. Candidates receive one zinc sulfate(220mg) tablet+ two pentoxifylline tablets(400 mg) daily for 3 month (TRENTAL 400 mg modified release tablets, OSPS; 400 mg +Zinc Sulfate 220mg Capsules) Other Names: zinc sulfate | Drug: Zinc Sulfate 220 mg Capsules<br>* Zinc is an element that is involved in the activity of antioxidant enzymes. For example, the superoxide dismutase needs copper and zinc to function properly. Infertile men with asthenospermia receive 220 mg zinc sulfate tablets for 3 months<br>* Other names: zinc;Drug: Pentoxifylline<br>* Oral use of pentoxifylline is effective in treating cardiovascular disease, cerebrovascular disease, and other conditions associated with local circulatory disorders. Pentoxifylline affects blood viscosity. Infertile men with asthenospermia receive 400 mg pentoxifylline tablets for 3 months<br>* Other names: Trental;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm concentration | count of sperm(In per million - with the help of a neobar slide and microscopic observation | 1 day | 
| spem motility | motility of sperm: Calculate the percentage of motile sperm using microscopic observation | 1 day | 
| sperm morphology | Calculate the percentage of sperm with a normal shape with the help of Papanic staining | 1 day | 
| lipid proxidation | Malondialdehyde (nmol/mL), is measured using related experimental kits | One week | 
| reactive oxygen species | eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits | One week | 
| total antioxidant capacity | total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits | One week | 
| FSH hormon | FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit | One week | 
| LH hormon | LH (IU / L) is measured from the blood serum of volunteers using ELISA kit | One week | 
| testosteron hormon [ Time Frame: One week after starting the medication ] testosterone | testosterone (nanomolar per liter) is measured from the blood serum of volunteers using ELISA kit | One week | 
| (Tissue necrosis Factor) | TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor is measured using related experimental kit | One week | 
| interleukin-6 | interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor is measured using related experimental kit | One week | 
| Sperm DNA Fragmentation Assay(SDFA) | DNA fragmentation is assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm). | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BAX expression | BAX expression [ Time Frame: 3 months ] expression of BAX gen(in p.c) using real-time PCR and Western blot | 3 month | 
| Bcl2 expression | Bcl-2 gen(in p.c) using real-time PCR and Western blot | 3 months | 
| caspase 3 expression | expression of caspase 3 gen(in p.c) using real-time PCR and Western blot | 3 months |