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

Overview

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.

Full Title of Study: “Evaluating the Therapeutic Effect of Pentoxifylline and Zinc Co-administration in Patients With Idiopathic Oligoasthenoteratozoospermia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 10, 2022

Detailed Description

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.

Interventions

  • Drug: Placebo
    • 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
  • Drug: Pentoxifylline
    • 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
  • Drug: zinc
    • 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
  • Drug: zinc + pentoxifylline
    • 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

Arms, Groups and Cohorts

  • Experimental: placebo group
    • Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily
  • Experimental: pentoxifylline group
    • Intervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily)
  • Experimental: Zinc group
    • Intervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily)
  • Experimental: pentoxifylline+ zinc group
    • 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 )

Clinical Trial Outcome Measures

Primary Measures

  • count of sperm
    • Time Frame: One week after starting the medication
    • count of sperm(In per million – with the help of a neobar slide and microscopic observation
  • motility of sperm
    • Time Frame: One week after starting the medication
    • motility of sperm: Calculate the percentage of motile sperm using microscopic observation
  • morphology of sperm
    • Time Frame: One week after starting the medication
    • Calculate the percentage of sperm with a normal shape with the help of Papanic staining
  • Malon di aldehyd evaluate
    • Time Frame: One week after starting the medication
    • Malondialdehyde (nmol/mL), will be measured using related experimental kits
  • ROS evaluate
    • Time Frame: One week after starting the medication
    • reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits
  • TAC (Total Antioxidant Capacity) evaluate
    • Time Frame: One week after starting the medication
    • total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits
  • FSH hormon
    • Time Frame: One week after starting the medication
    • FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
  • LH hormon
    • Time Frame: One week after starting the medication
    • LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
  • Testosteron hormon
    • Time Frame: One week after starting the medication
    • testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit
  • TNF α( Tissue necrosis Factor)
    • Time Frame: One week after starting the medication
    • TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor will be measured using related experimental kit
  • Interleukin-6 (IL-6)
    • Time Frame: One week after starting the medication
    • Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit
  • Sperm DNA Fragmentation Assay(SDFA)
    • Time Frame: One week after starting the medication
    • DNA fragmentation will be assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).

Participating in This Clinical Trial

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

Gender Eligibility: Male

men with idiopathic infertility

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Arak University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zeynab, Principal Investigator – Arak University of Medical Sciences

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