Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway

Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway in Spermatozoa and Seminal Plasma of Iraqi Asthenospermic Patients

Although many reports have investigated the relationship between subfertility and uric acid levels in semen, to the best of author knowledge, there is no study have been published to yet focus on the effects of asthenospermia treatments, such as given an oral zinc supplementation, on the activity of urate-related enzymes, which are important in fertility of human.

Study Overview

• Status: Completed
• Conditions: Infertility Unexplained
• Intervention / Treatment: Dietary supplement: Zinc Sulfate

Detailed Description

The present study was designed to investigate the effect of zinc supplementation on the qualitative and quantitative characteristics of semen, along with uric acid levels and urate-related enzymes in the seminal plasma and spermatozoa of asthenospermic males.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Babylon
    • Hilla, Babylon, Iraq, 51002
      • Mahmoud Hussein Hadwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 32 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• The presence of asthenozoospermia in the semen sample.
• Must be unable to reproduce.

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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).	Dietary supplement: Zinc Sulfate; 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	Measure Description	Time Frame
Measurement the uric acid level in spermatozoa and seminal plasma by using spectrophotometer.	Clinical parameter	up to three months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement the adenosine deaminase activity in spermatozoa and seminal plasma by using spectrophotometer.	Enzyme	up to three months.
Measurement the xanthine oxidase activity in spermatozoa and seminal plasma by using spectrophotometer.	Enzyme	up to three months.
Measurement the 5'-nucleotidase activity in spermatozoa and seminal plasmaby using the spectrophotometer.	Enzyme	up to three months.

Collaborators and Investigators

• Sponsor: Babylon University
• Collaborators: Ministry of Health, Iraq
• Investigators: Study Chair: Abdul Razzaq A. Alsalman, PhD, University of Babyblon; Study Director: Lamia A. Almashhedy, PhD, University of Babyblon; Principal Investigator: Mahmoud Hussein Hadwan, PhD, University of Babyblon; Study Director: Abdulsamie H Alta'ee, PhD, University of Babyblon

Publications and helpful links

General Publications

• Alsalman ARS, Almashhedy LA, Alta'ee AH, Hadwan MH. Effect of Zinc Supplementation on Urate Pathway Enzymes in Spermatozoa and Seminal Plasma of Iraqi Asthenozoospermic Patients: A Randomized Controlled Trial. Int J Fertil Steril. 2020 Jan;13(4):315-323. doi: 10.22074/ijfs.2020.5760. Epub 2019 Nov 11.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Uric acid; Adenosine deaminase; Zinc Sulfate; 5'-nucleotidase; Asthenospermia.; Xanthine oxidase
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Dermatologic Agents; Astringents; Zinc Sulfate
• Other Study ID Numbers: Babil-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No