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

Men Infertility Clinical Trial

— PTX-Zn  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05178953
• Other study ID #: 1898
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 1, 2021
• Est. completion date: January 20, 2022

Study information

• Verified date: January 2022
• Source: Arak University of Medical Sciences
• Contact: zeynab dadgar, dr
• Phone: 09163619937
• Email: z.dadgar67[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 20, 2022
• Est. primary completion date: January 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 23 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Men Infertility

Intervention

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
• 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Arak university of medical science	Arak	Markazi
Iran, Islamic Republic of	Infertility Center	Arak	Markazi

Sponsors (1)

Lead Sponsor	Collaborator
Arak University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sperm concentration	count of sperm(In per million - with the help of a neobar slide and microscopic observation	1 day
Primary	spem motility	motility of sperm: Calculate the percentage of motile sperm using microscopic observation	1 day
Primary	sperm morphology	Calculate the percentage of sperm with a normal shape with the help of Papanic staining	1 day
Primary	lipid proxidation	Malondialdehyde (nmol/mL), is measured using related experimental kits	One week
Primary	reactive oxygen species	eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits	One week
Primary	total antioxidant capacity	total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits	One week
Primary	FSH hormon	FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit	One week
Primary	LH hormon	LH (IU / L) is measured from the blood serum of volunteers using ELISA kit	One week
Primary	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
Primary	(Tissue necrosis Factor)	TNF a( Tissue necrosis Factor) (pg/mL) as an inflammatory factor is measured using related experimental kit	One week
Primary	interleukin-6	interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor is measured using related experimental kit	One week
Primary	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	BAX expression	BAX expression [ Time Frame: 3 months ]; expression of BAX gen(in p.c) using real-time PCR and Western blot	3 month
Secondary	Bcl2 expression	Bcl-2 gen(in p.c) using real-time PCR and Western blot	3 months
Secondary	caspase 3 expression	expression of caspase 3 gen(in p.c) using real-time PCR and Western blot	3 months