Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluating the Therapeutic Effect of Pentoxifylline and Zinc Co-administration in Patients With Idiopathic Oligoasthenoteratozoospermia

Conditions
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Idiopathic Infertility

Intervention / Treatment
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* Drug: Placebo
* Drug: Pentoxifylline
* Drug: zinc
* Drug: zinc + pentoxifylline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic infertile men have had at least one year of unprotected intercourse infertility Sperm parameters abnormality 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 diabetes mellitus consumption of medications affecting carbohydrate metabolism 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: 20 Years
Maximum Age: 50 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: placebo group<br>Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily | Drug: Placebo<br>* 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<br>* Other names: hydration solution;|
| Experimental: pentoxifylline group<br>Intervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily) | Drug: Pentoxifylline<br>* 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<br>* Other names: Trental;|
| Experimental: Zinc group<br>Intervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily) | Drug: zinc<br>* 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<br>* Other names: zinc sulfate;|
| Experimental: pentoxifylline+ zinc group<br>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 ) | Drug: zinc + pentoxifylline<br>* 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<br>* Other names: zinc sulfate+ trental;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 |