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Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers

Primary Purpose

Asthenozoospermia

Status

Completed

Phase

Phase 2

Locations

Iraq

Study Type

Interventional

Intervention

zinc sulfate

About this trial

This is an interventional treatment trial for Asthenozoospermia focused on measuring Zinc supplementation., Oxidative stress., Superoxide radical scavengers., Asthenospermia., Oxido-sensitive index.

Eligibility Criteria

26 Years - 36 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Babylon University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Zinc sulfate

Healthy control

Arm Description

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).

60 fertile (age 31.6±3.3 year) men, no treatment.

Outcomes

Primary Outcome Measures

Oxido-sensitive index level in spermatozoa and seminal plasma.

Secondary Outcome Measures

Volume of semen.

Xanthine oxidase activity in spermatozoa and seminal plasma.

Catalase like activity in spermatozoa and seminal plasma.

Superoxide dismutase activity in spermatozoa and seminal plasma.

Progressive sperm motility percentage.

Total normal sperm count.

Full Information

NCT ID

NCT02217189

First Posted

August 6, 2014

Last Updated

February 1, 2017

Sponsor

Babylon University

Collaborators

Ministry of Health, Iraq

1. Study Identification

Unique Protocol Identification Number

NCT02217189

Brief Title

Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers

Official Title

Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers in Spermatozoa of Patients With Asthenospermia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Babylon University

Collaborators

Ministry of Health, Iraq

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthenozoospermia

Keywords

Zinc supplementation., Oxidative stress., Superoxide radical scavengers., Asthenospermia., Oxido-sensitive index.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zinc sulfate

Arm Type

Experimental

Arm Description

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).

Arm Title

Healthy control

Arm Type

No Intervention

Arm Description

60 fertile (age 31.6±3.3 year) men, no treatment.

Intervention Type

Dietary Supplement

Intervention Name(s)

zinc sulfate

Intervention Description

The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).

Primary Outcome Measure Information:

Title

Oxido-sensitive index level in spermatozoa and seminal plasma.

Time Frame

up to three months.

Secondary Outcome Measure Information:

Title

Volume of semen.

Time Frame

up to three months.

Title

Xanthine oxidase activity in spermatozoa and seminal plasma.

Time Frame

up to three months.

Title

Catalase like activity in spermatozoa and seminal plasma.

Time Frame

up to three months.

Title

Superoxide dismutase activity in spermatozoa and seminal plasma.

Time Frame

up to three months.

Title

Progressive sperm motility percentage.

Time Frame

up to three months

Title

Total normal sperm count.

Time Frame

up to three months.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

26 Years

Maximum Age & Unit of Time

36 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahmoud H. Hadwan, PhD

Organizational Affiliation

Babylon University/ Iraq

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lamia A. Almashhedy, PhD

Organizational Affiliation

Babylon University/ Iraq

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Abdulrrazaq S. Alsalman, PhD

Organizational Affiliation

Babylon University/ Iraq

Official's Role

Study Chair

Facility Information:

Facility Name

Babylon University

City

Hilla

State/Province

Babylon

ZIP/Postal Code

51002

Country

Iraq

12. IPD Sharing Statement

Citations:

PubMed Identifier

26780395

Citation

Hadwan MH, Almashhedy LA, Alsalman AR. Oral Zinc Supplementation Restores Superoxide Radical Scavengers to Normal Levels in Spermatozoa of Iraqi Asthenospermic Patients. Int J Vitam Nutr Res. 2015;85(3-4):165-73. doi: 10.1024/0300-9831/a000235.

Results Reference

derived

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Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers

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