NCT02814695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
4.1 years until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

June 21, 2016

Last Update Submit

December 9, 2021

Conditions

Infertility, Male

Keywords

Male infertilityoxidative stressantioxidantsprobioticsVitamin EBaker's Yeast

Outcome Measures

Primary Outcomes (4)

  • total motile sperm

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

    30 minutes

  • progressive motile sperm

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

    30 minutes

  • vitality

    Number of Vital sperms in prepared semen sample per HPF

    30 minutes

  • oxidative stress

    level of oxidative stress (OS) By Oxisperm Kit

    30 minutes

Study Arms (4)

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.

Dietary Supplement: Vit E

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.

Dietary Supplement: Yeast

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.

Dietary Supplement: Vit C 1Dietary Supplement: Vit C 2Dietary Supplement: Vit C 3

Interventions

Vit EDIETARY_SUPPLEMENT

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 E supplementation
YeastDIETARY_SUPPLEMENT

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.

Yeast supplementation
Vit C 1DIETARY_SUPPLEMENT

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 supplementation
Vit C 2DIETARY_SUPPLEMENT

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 supplementation
Vit C 3DIETARY_SUPPLEMENT

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.

Vit C supplementation

Eligibility Criteria

Age22 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • must have not received an antibiotic treatment for the last 4 weeks prior to sampling
  • showed oxidative stress- mediated asthenozoospermia in their semen

You may not qualify if:

  • Severe male Factor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hawaa Fertility center

Banhā, Qalyubia Governorate, 13512, Egypt

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Yeast, Dried

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ahmed S Saad, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: control, vit E, vit C, Yeast
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Ob.&Gyn.

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 28, 2016

Study Start

August 15, 2020

Primary Completion

November 2, 2021

Study Completion

November 9, 2021

Last Updated

December 29, 2021

Record last verified: 2021-12

Locations

EG(1)