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

Arak University of Medical Sciences

Status and phase: Unknown; Early Phase 1

Conditions: Men Infertility

Treatments: Drug: Zinc Sulfate 220 mg Capsules; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT05178953

1898

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: Male

Ages: 23 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 3 patient groups

pentoxifylline group

Experimental group

Description:

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

Treatment:

Drug: Pentoxifylline

Zinc Sulfate group

Experimental group

Description:

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

Treatment:

Drug: Zinc Sulfate 220 mg Capsules

pentoxifylline+ zinc group

Experimental group

Description:

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

Treatment:

Drug: Pentoxifylline

Drug: Zinc Sulfate 220 mg Capsules