Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 228 for:    yeast

Yeast Cells as Antioxidant-Producing Probiotics (Probiotics)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02814695
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : January 4, 2017
Sponsor:
Collaborators:
Hawaa Fertility Center
Zagazig University
Information provided by (Responsible Party):
Ahmed Saad, 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.

Condition or disease Intervention/treatment Phase
Infertility, Male Dietary Supplement: Vit E 1 Dietary Supplement: Vit E 2 Dietary Supplement: Vit E 3 Dietary Supplement: YE 1 Dietary Supplement: YE 2 Dietary Supplement: YE 3 Dietary Supplement: Vit C 1 Dietary Supplement: Vit C 2 Dietary Supplement: Vit C 3 Early Phase 1

Detailed Description:

The practical part of the study took place from August 2015 to May 2016. 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, 3rd, 4th fractions (Vit. E 1,2,3), 0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (1, 2, 5 mg/ml) Vitamin E respectively and 5th, 6th, 7th parts fractions (Yeast extraction ( YE) 1,2,3), 0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (10, 20, 50 mg/ml) Yeast extraction and incubated at 37o C for 30 minutes.

Vitamin C was obtained from (Sigma, Germany), 8th, 9th, 10th 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Can Yeast Cells Emulate Vitamin E on In-vitro Protection of Human Spermatozoa Against Oxidative Stress?
Study Start Date : August 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016


Arm Intervention/treatment
No Intervention: 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.
Experimental: Vit E
2nd, 3rd, 4th fractions (Vit. E 1,2,3), 0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (1, 2, 5 mg/ml) Vitamin E respectively and incubated at 37o C for 30 minutes.
Dietary Supplement: Vit E 1
Dietary Supplement: Vit E 2
Dietary Supplement: Vit E 3
Experimental: YE
5th, 6th, 7th parts fractions ( YE 1,2,3), 0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (10, 20, 50 mg/ml) Yeast extraction and incubated at 37o C for 30 minutes.
Dietary Supplement: YE 1
Dietary Supplement: YE 2
Dietary Supplement: YE 3
Experimental: Vit C
8th, 9th, 10th 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.
Dietary Supplement: Vit C 1
Dietary Supplement: Vit C 2
Dietary Supplement: Vit C 3



Primary Outcome Measures :
  1. Number of motile sperms in prepared semen sample per high power field (HPF) [ Time Frame: 30 minutes ]
  2. Number of progressively-motile sperms in prepared semen sample per HPF [ Time Frame: 30 minutes ]
  3. Number of Vital sperms in prepared semen sample per HPF [ Time Frame: 30 minutes ]
  4. level of oxidative stress (OS) By Oxisperm Kit [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814695


Sponsors and Collaborators
Benha University
Hawaa Fertility Center
Zagazig University
Investigators
Layout table for investigator information
Principal Investigator: Ahmed S Saad, MD Benha University

Layout table for additonal information
Responsible Party: Ahmed Saad, Lecturer of Ob.&Gyn., Benha University
ClinicalTrials.gov Identifier: NCT02814695     History of Changes
Other Study ID Numbers: HAWAA-001
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016
Keywords provided by Ahmed Saad, Benha University:
Male infertility
oxidative stress
antioxidants
probiotics
Vitamin E
Baker's Yeast
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Ascorbic Acid
Antioxidants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents