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.

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

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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