We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01612403
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
mahmoud hussein hadwan, Babylon University

Brief Summary:
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 or disease Intervention/treatment
Asthenozoospermia Dietary Supplement: zinc sulfate

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
Actual Enrollment : 37 participants
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
Study Start Date : July 2011
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: infertility



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   27 Years to 35 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by mahmoud hussein hadwan, 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
Astringents
Dermatologic Agents