The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc in Men With Idiopathic Asthenozoospermia (PTX-Zn)

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

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

Study Overview

• Status: Recruiting
• Conditions: Men Infertility
• Intervention / Treatment: Drug: Pentoxifylline; Drug: Zinc Sulfate 220 mg Capsules

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: zeynab dadgar, dr; Phone Number: arak 09163619937; Email: z.dadgar67@gmail.com
• Study Contact Backup: Name: hamzeh amiri, dr; Phone Number: shafa 09163631770; Email: h.amiri65@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Markazi
    • Arak, Markazi, Iran, Islamic Republic of, 6853462355
      • Recruiting
      • Infertility Center
      • Contact: zeynab dadgar, dr; Phone Number: +989163619937; Email: z.dadgar67@gmail.com
    • Arak, Markazi, Iran, Islamic Republic of, 68985432
      • Completed
      • Arak university of medical science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pentoxifylline group; 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; 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; Other Names: Trental
Experimental: Zinc Sulfate group; 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; 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; Other Names: zinc
Experimental: pentoxifylline+ zinc group; 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: Pentoxifylline; 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; Other Names: Trental; Drug: Zinc Sulfate 220 mg Capsules; 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; Other Names: zinc

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arak University of Medical Sciences
• Investigators: Principal Investigator: zeynab dadgar, dr, Arak university of medical science

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): January 8, 2022
• Study Completion (Anticipated): January 20, 2022

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Dermatologic Agents; Trace Elements; Micronutrients; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Astringents; Zinc; Zinc Sulfate; Pentoxifylline
• Other Study ID Numbers: 1898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No