AsthenozoospermiaPhase 2NCT02985905
The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index
A Phase 2 study testing zinc sulfate in people with Asthenozoospermia, run by mahmoud hussein hadwan at 1 site in Iraq.
Trial summary
Although several studies have considered the relationship between infertility and semen thiol compounds levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on thiol related enzymes activity which are important in fertility of the individual has been reported. 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.
About this study
Official title: The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index and Thiol Related Enzymes in Spermatozoa of Iraqi Asthenospermic Patients
Although several studies have considered the relationship between infertility and semen thiol compounds levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on thiol related enzymes 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 reduced thiol, oxidized thiol and thiol related enzymes in the seminal plasma of asthenospermic patients.
- Conditions
- Asthenozoospermia
- Being tested
- zinc sulfate
- Keywords
- Zinc supplementation, Thiol, Glutathione peroxidase, Sulfhydryl oxidase
- 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 group | Role | What they receive |
|---|---|---|
| Zinc sulfate | Experimental | 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). Receives: Dietary Supplement: zinc sulfate |
| Healthy control | No intervention | 60 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.
Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels.
Measured: up to three months.
Secondary outcomes (2)
Glutathione peroxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Glutathione peroxidase activity levels.
Measured: up to three months.
Sulfhydryl oxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Sulfhydryl oxidase activity levels.
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.
- First posted7 Dec 2016 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthenozoospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- mahmoud hussein hadwan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Iraq
- Responsible party
- Sponsor-investigator, mahmoud hussein hadwan, Babylon University
- Investigators
- Mahmoud Hadwan, PhD, Principal investigator, Babylon UniversityL Almashhedy, PhD, Study director, Babylon UniversityAlsalman Abdulrrazaq, PhD, Study chair, Babylon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985905
- Sponsor's protocol ID
- Babil-4
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: I plan to publish the results in a scientific journal
Publications
Alsalman ARS, Almashhedy LA, Hadwan MH. Effect of Oral Zinc Supplementation on the Thiol Oxido-Reductive Index and Thiol-Related Enzymes in Seminal Plasma and Spermatozoa of Iraqi Asthenospermic Patients. Biol Trace Elem Res. 2018 Aug;184(2):340-349. doi: 10.1007/s12011-017-1215-8. Epub 2017 Dec 8.
PubMed 29222649
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index and Thiol Related Enzymes in Spermatozoa of Iraqi Asthenospermic Patients
- ClinicalTrials.gov ID
- NCT02985905
- Acronym / sponsor ID
- Babil-4
- Conditions
- Asthenozoospermia
- Keywords
- Zinc supplementation, Thiol, Glutathione peroxidase, Sulfhydryl oxidase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- mahmoud hussein hadwanUniversity, hospital or other
- Collaborators
- Ministry of Health, Iraq
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although several studies have considered the relationship between infertility and semen thiol compounds levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on thiol related enzymes activity which are important in fertility of the individual has been reported.
Detailed description
The present study was conducted to study the effect of zinc supplementation on the quantitative and qualitative characteristics of semen along with reduced thiol, oxidized thiol and thiol related enzymes in the seminal plasma of asthenospermic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc sulfate | Experimental | Dietary Supplement: zinc sulfate60 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). |
| Healthy control | No intervention | –60 fertile (age 31.6±3.3 year) men, no treatment |
Who may qualify
- Ages
- 26 to 36 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The presence of asthenozoospermia in the semen sample.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc sulfateThe subfertile group 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 |
Primary outcome
Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels.
Time frame: up to three months.
2 secondary outcomes
Glutathione peroxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Glutathione peroxidase activity levels.
Time frame: up to three months.
Sulfhydryl oxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Sulfhydryl oxidase activity levels.
Time frame: up to three months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Derived from this study: PubMed 29222649Alsalman ARS, Almashhedy LA, Hadwan MH. Effect of Oral Zinc Supplementation on the Thiol Oxido-Reductive Index and Thiol-Related Enzymes in Seminal Plasma and Spermatozoa of Iraqi Asthenospermic Patients. Biol Trace Elem Res. 2018 Aug;184(2):340-349. doi: 10.1007/s12011-017-1215-8. Epub 2017 Dec 8.
- Individual participant dataSharing planned: Yes. I plan to publish the results in a scientific journal
Related trials for Asthenozoospermia
Not yet recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of Multiple Dose of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia.
Oligozoospermia and/or Asthenozoospermia
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
Recruiting
Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress
Male Infertility, Oxidative Stress
Recruiting
Probiotics on Sperm Quality in Male Infertility Patients
Male Infertility, Oligozoospermia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Hadwan, PhD principal investigator
Babylon University
L Almashhedy, PhD study director
Babylon University
Alsalman Abdulrrazaq, PhD study chair
Babylon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zinc sulfate in people with Asthenozoospermia, run by mahmoud hussein hadwan 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 7 Dec 2016. 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?
Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels. (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 NCT02985905, 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 7 Dec 2016.