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Clinical Trials/NCT02814695
NCT02814695CompletedPhase 1

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

Benha University1 site in 1 country40 target enrollmentStarted: August 15, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
oxidative stress

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
22 Years to 35 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control

No Intervention

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.

Vit E supplementation

Experimental

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: Vit E (Dietary Supplement)

Vit C supplementation

Experimental

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: Vit C 1 (Dietary Supplement)

Vit C supplementation

Experimental

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: Vit C 2 (Dietary Supplement)

Vit C supplementation

Experimental

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: Vit C 3 (Dietary Supplement)

Yeast supplementation

Experimental

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: Yeast (Dietary Supplement)

Outcomes

Primary Outcomes

oxidative stress

Time Frame: 30 minutes

level of oxidative stress (OS) By Oxisperm Kit

total motile sperm

Time Frame: 30 minutes

Number of motile sperms in prepared semen sample per high power field (HPF)

progressive motile sperm

Time Frame: 30 minutes

Number of progressively-motile sperms in prepared semen sample per HPF

vitality

Time Frame: 30 minutes

Number of Vital sperms in prepared semen sample per HPF

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Saad

Assistant professor of Ob.&Gyn.

Benha University

Study Sites (1)

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