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

Arak University of Medical Sciences

Status: Unknown

Conditions: Idiopathic Infertility

Treatments: Drug: Pentoxifylline; Drug: Placebo; Drug: zinc; Drug: zinc + pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT05156684

96/197

Details and patient eligibility

About

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 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.

Enrollment: 140 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups

placebo group

Experimental group

Description:

Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily

Treatment:

Drug: Placebo

pentoxifylline group

Experimental group

Description:

Intervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily)

Treatment:

Drug: Pentoxifylline

Zinc group

Experimental group

Description:

Intervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily)

Treatment:

Drug: zinc

pentoxifylline+ zinc group

Experimental group

Description:

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 )

Treatment:

Drug: zinc + pentoxifylline