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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02814695
Other study ID # HAWAA-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 15, 2020
Est. completion date November 9, 2021

Study information

Verified date December 2021
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 9, 2021
Est. primary completion date November 2, 2021
Accepts healthy volunteers No
Gender Male
Age group 22 Years to 35 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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.
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 1
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 2
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 3
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.

Locations

Country Name City State
Egypt hawaa Fertility center Banha Qalyubiya

Sponsors (3)

Lead Sponsor Collaborator
Benha University Hawaa Fertility Center, Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary total motile sperm Number of motile sperms in prepared semen sample per high power field (HPF) 30 minutes
Primary progressive motile sperm Number of progressively-motile sperms in prepared semen sample per HPF 30 minutes
Primary vitality Number of Vital sperms in prepared semen sample per HPF 30 minutes
Primary oxidative stress level of oxidative stress (OS) By Oxisperm Kit 30 minutes
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