Yeast Cells as Antioxidant-Producing Probiotics

Phase 1

Completed

• Conditions: Infertility, Male
• Interventions: Dietary Supplement: Yeast; Dietary Supplement: Vit C 1; Dietary Supplement: Vit E; Dietary Supplement: Vit C 2; Dietary Supplement: Vit C 3

• Registration Number: NCT02814695
• Lead Sponsor: Benha University

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.

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Study Start: 2020-08-15
• Primary Completion: 2021-11-02
• Study Completion: 2021-11-09
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yeast supplementation	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 supplementation	Vit C 1	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.
Vit C supplementation	Vit C 2	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.
Vit E supplementation	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.
Vit C supplementation	Vit C 3	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.

Primary Outcome Measures

Name	Time	Method
oxidative stress	30 minutes	level of oxidative stress (OS) By Oxisperm Kit
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

Trial Locations

Locations (1)

hawaa Fertility center; 🇪🇬 Banhā, Qalyubiya, Egypt