Yeast Cells as Antioxidant-Producing Probiotics

Study Overview
=================
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.

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.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control, vit E, vit C, Yeast
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* 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.<br>|
| Experimental: Yeast supplementation<br>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<br>* 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.<br>|
| Experimental: Vit C supplementation<br>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<br>* 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.<br>Dietary Supplement: Vit C 2<br>* 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.<br>Dietary Supplement: Vit C 3<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antioxidants, Male infertility, oxidative stress, probiotics, Vitamin E, Baker's Yeast