- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02217189
Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers
February 1, 2017 updated by: mahmoud hussein hadwan, Babylon University
Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers in Spermatozoa of Patients With Asthenospermia
Although several studies have considered the relationship between infertility and semen super oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on superoxide radical scavengers activity which are important in fertility of the individual has been reported.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present study was conducted to study the effect of zinc supplementation on the quantitative and qualitative characteristics of semen along with superoxide radical scavengers activity in the seminal plasma of asthenospermic patients.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Babylon
-
Hilla, Babylon, Iraq, 51002
- Babylon University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
26 years to 36 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- the presence of asthenozoospermia in the semen sample.
Exclusion Criteria:
- the absence of endocrinopathy, varicocele, and female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zinc sulfate
60 subfertile (age 32.5±3.23 year) men with asthenozoospermia was treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
|
The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
|
No Intervention: Healthy control
60 fertile (age 31.6±3.3
year) men, no treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oxido-sensitive index level in spermatozoa and seminal plasma.
Time Frame: up to three months.
|
up to three months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Volume of semen.
Time Frame: up to three months.
|
up to three months.
|
Xanthine oxidase activity in spermatozoa and seminal plasma.
Time Frame: up to three months.
|
up to three months.
|
Catalase like activity in spermatozoa and seminal plasma.
Time Frame: up to three months.
|
up to three months.
|
Superoxide dismutase activity in spermatozoa and seminal plasma.
Time Frame: up to three months.
|
up to three months.
|
Progressive sperm motility percentage.
Time Frame: up to three months
|
up to three months
|
Total normal sperm count.
Time Frame: up to three months.
|
up to three months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mahmoud H. Hadwan, PhD, Babylon University/ Iraq
- Study Director: Lamia A. Almashhedy, PhD, Babylon University/ Iraq
- Study Chair: Abdulrrazaq S. Alsalman, PhD, Babylon University/ Iraq
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
August 6, 2014
First Submitted That Met QC Criteria
August 13, 2014
First Posted (Estimate)
August 15, 2014
Study Record Updates
Last Update Posted (Estimate)
February 3, 2017
Last Update Submitted That Met QC Criteria
February 1, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Babil-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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