Yeast Cells as Antioxidant-Producing Probiotics (Probiotics)

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Male
• Intervention / Treatment: Dietary supplement: Vit E; Dietary supplement: Yeast; Dietary supplement: Vit C 1; Dietary supplement: Vit C 2; Dietary supplement: Vit C 3

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Qalyubiya
    • Banhā, Qalyubiya, Egypt, 13512
      • Hawaa Fertility center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; 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.
EXPERIMENTAL: Vit E supplementation; 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.	Dietary supplement: Vit E; 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.
EXPERIMENTAL: Yeast supplementation; 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.	Dietary supplement: Yeast; 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.
EXPERIMENTAL: Vit C supplementation; 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.	Dietary supplement: Vit C 1; 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.; Dietary supplement: Vit C 2; 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.; Dietary supplement: Vit C 3; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total motile sperm	Number of motile sperms in prepared semen sample per high power field (HPF)	30 minutes
progressive motile sperm	Number of progressively-motile sperms in prepared semen sample per HPF	30 minutes
vitality	Number of Vital sperms in prepared semen sample per HPF	30 minutes
oxidative stress	level of oxidative stress (OS) By Oxisperm Kit	30 minutes

Collaborators and Investigators

• Sponsor: Benha University
• Collaborators: Zagazig University; Hawaa Fertility Center
• Investigators: Principal Investigator: Ahmed S Saad, MD, Benha University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2020
• Primary Completion (ACTUAL): November 2, 2021
• Study Completion (ACTUAL): November 9, 2021

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (ESTIMATE): June 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Vitamin E; probiotics; oxidative stress; antioxidants; Male infertility; Baker's Yeast
• Additional Relevant MeSH Terms: Infertility; Infertility, Male; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: HAWAA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not decided yet, but the data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No