Yeast Cells as Antioxidant-Producing Probiotics

Sponsor

Benha University (Other)

Overall Status

Completed

CT.gov ID

NCT02814695

Collaborator

Hawaa Fertility Center (Other), Zagazig University (Other)

Enrollment

Location

Arms

14.8

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Male	Dietary Supplement: Vit E Dietary Supplement: Yeast Dietary Supplement: Vit C 1 Dietary Supplement: Vit C 2 Dietary Supplement: Vit C 3	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

control, vit E, vit C, Yeastcontrol, vit E, vit C, Yeast

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Aug 15, 2020

Actual Primary Completion Date :

Nov 2, 2021

Actual Study Completion Date :

Nov 9, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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