Clinical trial NCT02814695: Yeast Cells as Antioxidant-Producing Probiotics
Official title: Can Yeast Cells Emulate Vitamin E on In-vitro Protection of Human Spermatozoa Against Oxidative Stress?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infertility, Male
Keywords: Male infertility
oxidative stress
antioxidants
probiotics
Vitamin E
Baker's Yeast
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Hawaa Fertility Center
name: Zagazig University
First posted: 2016-06-28
Enrollment: 40
Sex: MALE
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control, vit E, vit C, Yeast
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: total motile sperm
timeFrame: 30 minutes
measure: progressive motile sperm
timeFrame: 30 minutes
measure: vitality
timeFrame: 30 minutes
measure: oxidative stress
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: hawaa Fertility center
state: Qalyubiya
Study officials:
affiliation: Benha University
name: Ahmed S Saad, MD
role: PRINCIPAL_INVESTIGATOR
References: