- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985905
The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index
December 6, 2016 updated by: mahmoud hussein hadwan
The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index and Thiol Related Enzymes in Spermatozoa of Iraqi Asthenospermic Patients
Although several studies have considered the relationship between infertility and semen thiol compounds levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on thiol related enzymes 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 reduced thiol, oxidized thiol and thiol related enzymes 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
- Mahmoud Hadwan
-
-
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
No
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 Assignment
- Masking: None (Open Label)
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 |
---|---|
Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels.
Time Frame: up to three months.
|
up to three months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glutathione peroxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Glutathione peroxidase activity levels.
Time Frame: up to three months.
|
up to three months.
|
Sulfhydryl oxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Sulfhydryl oxidase activity levels.
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 Hadwan, PhD, Babylon University
- Study Director: L Almashhedy, PhD, Babylon University
- Study Chair: Alsalman Abdulrrazaq, PhD, Babylon University
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)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
December 2, 2016
First Submitted That Met QC Criteria
December 6, 2016
First Posted (Estimate)
December 7, 2016
Study Record Updates
Last Update Posted (Estimate)
December 7, 2016
Last Update Submitted That Met QC Criteria
December 6, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Babil-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
I plan to publish the results in a scientific journal
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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