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临床试验/NCT02814695
NCT02814695已完成1 期

Can Yeast Cells Emulate Vitamin E on In-vitro Protection of Human Spermatozoa Against Oxidative Stress?

Benha University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月15日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
2
主要终点
oxidative stress

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of Baker's yeast extractions , probiotic antioxidant, in scavenging the oxidative stress status mediated damage on sperm motility,progressive motility and vitality as well as comparing this potency to that of Vitamin E in infertile men.

详细描述

The practical part of the study took place from August 2020 to November 2021. The Study population was made up of infertile males attending Hawaa fertility center, banha city, Qaliubiya, Egypt.

40 study samples were collected from patients who indicated willingness to participate in the study and have had 3 to 7 days of sexual abstinence, using the masturbation method and ejaculated in wide mouthed plastic container as described by World Health Organization (WHO).

Samples were allowed to liquefy for 20 minutes and were examined for volume, viscosity, spermatozoa count by Neubauer haemocytometer , oxidative stress level measurement by Oxisperm, percentage of progressive motility and non-progressive motility and sperm vitality.

The Semen specimens were divided into ten equal fractions. First fraction was control, 0.1ml of liquefied semen mixed with 0.1ml Ham's F10 medium and incubated at 37o C for 30 minutes., 2nd: Vit. E, 3rd (Yeast extraction ( YE).Vitamin C was obtained from (Sigma, Germany), 3rd, 4th, 5th fractions (Vit. C. 1,2,3), 0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.02, 0.04, 0.06 mg/ml) Vitamin C respectively and incubated at 37o C for 30 minutes.

After semen specimen treated in all fractions, they were examined and assessed for microscopical changes, total motility, progressive motility, vitality, level of oxidative stress (OS) were detected in all fractions 30 minutes later after addition of the antioxidants.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
22 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • must have been married for 1 year before inclusion into the study and were unable to achieve pregnancy
  • must have not received an antibiotic treatment for the last 4 weeks prior to sampling
  • showed oxidative stress- mediated asthenozoospermia in their semen

排除标准

  • Severe male Factor

结局指标

主要结局

oxidative stress

时间窗: 30 minutes

level of oxidative stress (OS) By Oxisperm Kit

total motile sperm

时间窗: 30 minutes

Number of motile sperms in prepared semen sample per high power field (HPF)

progressive motile sperm

时间窗: 30 minutes

Number of progressively-motile sperms in prepared semen sample per HPF

vitality

时间窗: 30 minutes

Number of Vital sperms in prepared semen sample per HPF

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Saad

Assistant professor of Ob.&Gyn.

Benha University

研究点 (2)

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