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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
mahmoud hussein hadwan, Babylon University
ClinicalTrials.gov Identifier:
NCT01612403
First received: June 1, 2012
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Asthenozoospermia
 Dietary Supplement: zinc sulfate

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Babylon University:

Primary Outcome Measures:
  • high molecular weight zinc binding protein [ Time Frame: at the end of three months ] [ Designated as safety issue: Yes ]
    elevated levels of high molecular weight zinc binding protein to normal value


Secondary Outcome Measures:
  • qualitative semen parameters [ Time Frame: at the end of three months ] [ Designated as safety issue: Yes ]
    Volume of semen, progressive sperm motility percentage and total normal sperm count increased after zinc sulfate supplementation.


Enrollment: 37
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: infertility

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).

  Eligibility

Ages Eligible for Study:   27 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612403

Locations
Iraq
Babylon university/ college of science
Hilla, Iraq, IQ
Babylon University
Hilla, Iraq, IQ
Sponsors and Collaborators
mahmoud hussein hadwan
Investigators
Principal Investigator: mahmoud H. hadwan, Dr. babylon university / Iraq
  More Information

No publications provided by Babylon University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: mahmoud hussein hadwan, Researcher, Babylon University
ClinicalTrials.gov Identifier: NCT01612403     History of Changes
Other Study ID Numbers: babil-1
Study First Received: June 1, 2012
Last Updated: June 5, 2012
Health Authority: Iraq: Ethics Committee

Keywords provided by Babylon University:
zinc binding protein

Additional relevant MeSH terms:
Asthenozoospermia
Infertility, Male
Infertility
Genital Diseases, Male
Zinc
Zinc Sulfate
Trace Elements
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013