Yeast Cells as Antioxidant-Producing Probiotics

NCT ID: NCT02814695

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2021-11-09

Brief Summary

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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

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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.

Conditions

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Infertility, Male

Keywords

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Male infertility oxidative stress antioxidants probiotics Vitamin E Baker's Yeast

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

control, vit E, vit C, Yeast
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Vit E

Intervention Type 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 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.

Group Type EXPERIMENTAL

Yeast

Intervention Type 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 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.

Group Type EXPERIMENTAL

Vit C 1

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hawaa Fertility Center

OTHER

Sponsor Role collaborator

Zagazig University

OTHER_GOV

Sponsor Role collaborator

Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Saad

Assistant professor of Ob.&Gyn.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed S Saad, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

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hawaa Fertility center

Banhā, Qalyubia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HAWAA-001

Identifier Type: -

Identifier Source: org_study_id