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

Asthenozoospermia Clinical Trial

— supplement  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612403
• Other study ID #: babil-1
• Status: Completed
• Phase: N/A
• First received: June 1, 2012
• Last updated: June 5, 2012
• Start date: July 2011
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Babylon University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iraq: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 27 Years to 35 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthenozoospermia

Intervention

Dietary Supplement:
• zinc sulfate
every participant took two capsules of zinc sulfate per day for three months (each one 220mg)

Locations

Country	Name	City	State
Iraq	Babylon University	Hilla
Iraq	Babylon university/ college of science	Hilla

Sponsors (1)

Lead Sponsor	Collaborator
mahmoud hussein hadwan

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high molecular weight zinc binding protein	elevated levels of high molecular weight zinc binding protein to normal value	at the end of three months	Yes
Secondary	qualitative semen parameters	Volume of semen, progressive sperm motility percentage and total normal sperm count increased after zinc sulfate supplementation.	at the end of three months	Yes