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Yeast Cells as Antioxidant-Producing Probiotics (Probiotics)

Primary Purpose

Infertility, Male

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Vit E
Yeast
Vit C 1
Vit C 2
Vit C 3
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infertility, Male focused on measuring Male infertility, oxidative stress, antioxidants, probiotics, Vitamin E, Baker's Yeast

Eligibility Criteria

22 Years - 35 Years (Adult)MaleDoes not accept 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

Exclusion Criteria:

  • Severe male Factor

Sites / Locations

  • hawaa Fertility center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Vit E supplementation

Yeast supplementation

Vit C supplementation

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 21, 2016
Last Updated
December 9, 2021
Sponsor
Benha University
Collaborators
Hawaa Fertility Center, Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT02814695
Brief Title
Yeast Cells as Antioxidant-Producing Probiotics
Acronym
Probiotics
Official Title
Can Yeast Cells Emulate Vitamin E on In-vitro Protection of Human Spermatozoa Against Oxidative Stress?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
November 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
Collaborators
Hawaa Fertility Center, Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
Keywords
Male infertility, oxidative stress, antioxidants, probiotics, Vitamin E, Baker's Yeast

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
control, vit E, vit C, Yeast
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Vit E supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Yeast supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Vit C supplementation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vit E
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Yeast
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vit C 1
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vit C 2
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vit C 3
Intervention Description
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 Outcome Measure Information:
Title
total motile sperm
Description
Number of motile sperms in prepared semen sample per high power field (HPF)
Time Frame
30 minutes
Title
progressive motile sperm
Description
Number of progressively-motile sperms in prepared semen sample per HPF
Time Frame
30 minutes
Title
vitality
Description
Number of Vital sperms in prepared semen sample per HPF
Time Frame
30 minutes
Title
oxidative stress
Description
level of oxidative stress (OS) By Oxisperm Kit
Time Frame
30 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed S Saad, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
hawaa Fertility center
City
Banhā
State/Province
Qalyubiya
ZIP/Postal Code
13512
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
not decided yet, but the data will be shared

Learn more about this trial

Yeast Cells as Antioxidant-Producing Probiotics

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