Evaluating the Therapeutic Effect of Pentoxifylline and Zinc Co-administration in Patients With Idiopathic Oligoasthenoteratozoospermia

Arak University of Medical Sciences0 个研究点目标入组 140 人开始时间: 2022年1月1日最近更新: 2022年1月3日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Arak University of Medical Sciences
入组人数: 140
主要终点: count of sperm

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 20 Years 至 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Idiopathic infertile men
•have had at least one year of unprotected intercourse infertility
•Sperm parameters abnormality

排除标准

•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

研究组 & 干预措施

placebo group

Experimental

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

干预措施: Placebo (Drug)

pentoxifylline group

Experimental

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

干预措施: Pentoxifylline (Drug)

Zinc group

Experimental

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

干预措施: zinc (Drug)

pentoxifylline+ zinc group

Experimental

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 )

干预措施: zinc + pentoxifylline (Drug)