AzTrials
AzTrials

AsthenozoospermiaPhase 2NCT02217189

Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers

A Phase 2 study testing zinc sulfate in people with Asthenozoospermia, run by Babylon University at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Although several studies have considered the relationship between infertility and semen super oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on superoxide radical scavengers activity which are important in fertility of the individual has been… Read more about this study

Who is it for?
Ages 26 to 36 years, men onlyHealthy volunteers can take part
Conditions the study is for
Asthenozoospermia
What is being tested?
zinc sulfate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteIraq
Study dates
Jul 2011to Jul 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 26 to 36 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • the presence of asthenozoospermia in the semen sample.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Iraq1 site

  • Babylon University

    Hillah, Babylon, 51002

Other trials in Iraq

About this study

Official title: Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers in Spermatozoa of Patients With Asthenospermia

Although several studies have considered the relationship between infertility and semen super oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on superoxide radical scavengers activity which are important in fertility of the individual has been reported.

Read the detailed description

The present study was conducted to study the effect of zinc supplementation on the quantitative and qualitative characteristics of semen along with superoxide radical scavengers activity in the seminal plasma of asthenospermic patients.

Being tested
zinc sulfate
Keywords
Zinc supplementation., Oxidative stress., Superoxide radical scavengers., Asthenospermia., Oxido-sensitive index.
Medical subject headings
Asthenozoospermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zinc sulfateDietary supplement

    The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).

Study groups in NCT02217189
Study groupRoleWhat they receive
Zinc sulfateExperimental60 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).
Receives: Dietary Supplement: zinc sulfate
Healthy controlNo intervention60 fertile (age 31.6±3.3 year) men, no treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxido-sensitive index level in spermatozoa and seminal plasma.

    Measured: up to three months.

Secondary outcomes (6)

  1. Volume of semen.

    Measured: up to three months.

  2. Xanthine oxidase activity in spermatozoa and seminal plasma.

    Measured: up to three months.

  3. Catalase like activity in spermatozoa and seminal plasma.

    Measured: up to three months.

  4. Superoxide dismutase activity in spermatozoa and seminal plasma.

    Measured: up to three months.

  5. Progressive sperm motility percentage.

    Measured: up to three months

  6. Total normal sperm count.

    Measured: up to three months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2014 (estimated)
  2. Study startJul 2011
  3. Primary completionJun 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02217189
Sponsor's protocol ID
Babil-3
Status last verified
Feb 2017
First submitted
6 Aug 2014
Last updated
3 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • Hadwan MH, Almashhedy LA, Alsalman AR. Oral Zinc Supplementation Restores Superoxide Radical Scavengers to Normal Levels in Spermatozoa of Iraqi Asthenospermic Patients. Int J Vitam Nutr Res. 2015;85(3-4):165-73. doi: 10.1024/0300-9831/a000235.

    PubMed 26780395

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing zinc sulfate in people with Asthenozoospermia, run by Babylon University at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxido-sensitive index level in spermatozoa and seminal plasma. (time frame: up to three months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02217189, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in