Yeast Cells as Antioxidant-Producing Probiotics

Infertility, Male Clinical Trial

— Probiotics  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814695
• Other study ID #: HAWAA-001
• Status: Completed
• Phase: Phase 1
• Start date: August 15, 2020
• Est. completion date: November 9, 2021

Study information

• Verified date: December 2021
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 9, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	hawaa Fertility center	Banha	Qalyubiya

Sponsors (3)

Lead Sponsor	Collaborator
Benha University	Hawaa Fertility Center, Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

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