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Completed

NCT Number: NCT02814695

Yeast Cells as Antioxidant-Producing Probiotics

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.

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Key information

Conditions

Infertility, Male Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

22 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

hawaa Fertility center

Banhā, Qalyubia Governorate, 13512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Severe male Factor

Treatment and study plan

Vit E

Dietary Supplement

0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (2 mg/ml) Vitamin E and incubated at 37o C for 30 minutes.

Yeast

Dietary Supplement

0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (20 mg/ml) yeast extraction and incubated at 37o C for 30 minutes.

Vit C 1

Dietary Supplement

0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.02 mg/ml) Vitamin C and incubated at 37o C for 30 minutes.

Vit C 2

Dietary Supplement

0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.04 mg/ml) Vitamin C and incubated at 37o C for 30 minutes.

Vit C 3

Dietary Supplement

0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.06 mg/ml) Vitamin C and incubated at 37o C for 30 minutes.

Primary outcomes

  1. total motile sperm

    Time frame: 30 minutes

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

  2. progressive motile sperm

    Time frame: 30 minutes

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

  3. vitality

    Time frame: 30 minutes

    Number of Vital sperms in prepared semen sample per HPF

  4. oxidative stress

    Time frame: 30 minutes

    level of oxidative stress (OS) By Oxisperm Kit

Sponsors and collaborators

Lead sponsor

Benha University

Other

Collaborators

  • Hawaa Fertility Center
  • Zagazig University

Registry information

Official study title

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

Acronym: Probiotics

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2016
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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