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CompletedNCT03361618Updated Dec 5, 2017

Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway

An interventional study of Zinc Sulfate in Infertility Unexplained, sponsored by Babylon University. Completed at 1 site in Iraq. Open to male participants aged 26 Years to 36 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-05.

Sponsored by Babylon University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 4 months after the study started (first participant enrolled Jul 2011, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
26 Years to 36 Years
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Infertility Unexplained

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Keywords

  • Uric acid
  • Adenosine deaminase
  • Zinc Sulfate
  • 5'-nucleotidase
  • Asthenospermia.
  • Xanthine oxidase
03

In context

Asthenozoospermia

32 studies on the registry are indexed under Asthenozoospermia; 9 are open to participants now.

This study's enrollment of 120 is above the median of 62 across 25 interventional studies indexed under Asthenozoospermia.

Browse Asthenozoospermia studies →

Lead sponsor

Babylon University is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Years to 36 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • 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

  • No intervention
    Healthy control

    60 fertile (age 31.6±3.3 year) men, no treatment.

Interventions

  • Dietary supplementZinc 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).

06

What researchers measure

Primary outcomes

  1. Measurement the uric acid level in spermatozoa and seminal plasma by using spectrophotometer.

    Clinical parameter

    Time frame: up to three months.

Secondary outcomes

  1. Measurement the adenosine deaminase activity in spermatozoa and seminal plasma by using spectrophotometer.

    Enzyme

    Time frame: up to three months.

  2. Measurement the xanthine oxidase activity in spermatozoa and seminal plasma by using spectrophotometer.

    Enzyme

    Time frame: up to three months.

  3. Measurement the 5'-nucleotidase activity in spermatozoa and seminal plasmaby using the spectrophotometer.

    Enzyme

    Time frame: up to three months.

07

Study locations

1 site
  • Mahmoud Hussein Hadwan
    Hilla, Babylon 51002, Iraq
08

References and documents

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. PubMed 31710193 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2011 to primary completion in Jun 2012, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2017
First posted
Dec 5, 2017
StartActual
Jul 1, 2011
Primary completionActual
Jun 1, 2012
CompletionActual
Jun 1, 2012
Last update
Dec 5, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03361618
Lead sponsor
Babylon University
Collaborators
Ministry of Health, Iraq
Responsible party
mahmoud hussein hadwan (Principal Investigator Dr. Mahmoud Hussein Hadwan, Babylon University) — Principal investigator
First posted
Dec 5, 2017
Start date
Jul 1, 2011
Primary completion
Jun 1, 2012
Completion
Jun 1, 2012
Last update
Dec 5, 2017

Study contacts

Abdul Razzaq A. Alsalman, PhD
study chair · University of Babyblon
Lamia A. Almashhedy, PhD
study director · University of Babyblon
Mahmoud Hussein Hadwan, PhD
principal investigator · University of Babyblon
Abdulsamie H Alta'ee, PhD
study director · University of Babyblon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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