Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen (supplement)

June 5, 2012 updated by: mahmoud hussein hadwan
There are several causes leading to male infertility, like oxidative stress, and nutritional deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands (LMW). The present study was conducted to study the effect of Zn supplementation on the quantitative and qualitative characteristics of semen along with Zinc Binding Protein levels in semen of patients with asthenozoospmia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Elevation of ROS levels lead to an increase the oxidation of HMW-Zn binding proteins in seminal plasma of asthenozoospermic subjects. Zinc supplementation restores HMW-Zn% in seminal plasma of asthenozoospermic subjects to normal value. LMW-Zn% is elevated in seminal plasma of asthenozoospermic patients. It may be because increment the levels of semenogelin in seminal plasma of asthenozoospermic subjects. Zinc supplementation elevates LMW-Zn% in seminal plasma of asthenozoospermic subjects to more than normal value, this may be because of its enhancement of the synthesis of metallothioneins (Low molecular weight zinc binding protein).

Study Type

Observational

Enrollment (Actual)

37

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

  • Iraq
      • Hilla, Iraq, IQ
        • Babylon university/ college of science
      • Hilla, Iraq, IQ
        • 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

25 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

This study includes 37 subfertile male partners from couples who had consulted the infertility clinic of the Babil hospital of maternity (Hilla city/ IRAQ).

Description

Inclusion Criteria:

The inclusion criteria were 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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single group
Single group: all participants receive same intervention throughout study (Non-randomised)
Dietary supplement: zinc sulfate
every participant took two capsules of zinc sulfate per day for three months (each one 220mg)
Other Names:
  • infertility

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
high molecular weight zinc binding protein
Time Frame: at the end of three months
elevated levels of high molecular weight zinc binding protein to normal value
at the end of three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
qualitative semen parameters
Time Frame: at the end of three months
Volume of semen, progressive sperm motility percentage and total normal sperm count increased after zinc sulfate supplementation.
at the end of three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

mahmoud hussein hadwan

Investigators

  • Principal Investigator: mahmoud H. hadwan, Dr., 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.

General Publications

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)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

June 1, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • babil-1

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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