Infertility UnexplainedNCT03361618
Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway
A study testing Zinc Sulfate in people with Infertility Unexplained, run by Babylon University at 1 site in Iraq.
Trial 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… 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
- Infertility Unexplained
- 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
- 1 Jul 2011to 1 Jun 2012
- Phase
- Interventional
- 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.
- Must be unable to reproduce.
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: 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.
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.
- Conditions
- Infertility Unexplained
- Being tested
- Zinc Sulfate
- Keywords
- Uric acid, Adenosine deaminase, Zinc Sulfate, 5'-nucleotidase, Asthenospermia., Xanthine 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.
Measurement the uric acid level in spermatozoa and seminal plasma by using spectrophotometer.
Clinical parameter
Measured: up to three months.
Secondary outcomes (3)
Measurement the adenosine deaminase activity in spermatozoa and seminal plasma by using spectrophotometer.
Enzyme
Measured: up to three months.
Measurement the xanthine oxidase activity in spermatozoa and seminal plasma by using spectrophotometer.
Enzyme
Measured: up to three months.
Measurement the 5'-nucleotidase activity in spermatozoa and seminal plasmaby using the spectrophotometer.
Enzyme
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 posted5 Dec 2017
- Study start1 Jul 2011
- Primary completion1 Jun 2012
- Study completion1 Jun 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 Infertility UnexplainedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Semen volume after treatment.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babylon University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Iraq
- Responsible party
- Principal investigator, mahmoud hussein hadwan, Babylon University
- Investigators
- Abdul Razzaq A. Alsalman, PhD, Study chair, University of BabyblonLamia A. Almashhedy, PhD, Study director, University of BabyblonMahmoud Hussein Hadwan, PhD, Principal investigator, University of BabyblonAbdulsamie H Alta'ee, PhD, Study director, University of Babyblon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361618
- Sponsor's protocol ID
- Babil-5
- Status last verified
- Dec 2017
- First submitted
- 7 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway in Spermatozoa and Seminal Plasma of Iraqi Asthenospermic Patients
- ClinicalTrials.gov ID
- NCT03361618
- Acronym / sponsor ID
- Babil-5
- Conditions
- Infertility Unexplained
- Keywords
- Uric acid, Adenosine deaminase, Zinc Sulfate, 5'-nucleotidase, Asthenospermia., Xanthine oxidase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Babylon UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Iraq
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 5 Dec 2017 (actual)
- 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Semen volume after treatment.
| 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 (2 listed)
- The presence of asthenozoospermia in the semen sample.
- Must be unable to reproduce.
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
Measurement the uric acid level in spermatozoa and seminal plasma by using spectrophotometer.
Time frame: up to three months.
Clinical parameter
3 secondary outcomes
Measurement the adenosine deaminase activity in spermatozoa and seminal plasma by using spectrophotometer.
Time frame: up to three months.
Measurement the xanthine oxidase activity in spermatozoa and seminal plasma by using spectrophotometer.
Time frame: up to three months.
Measurement the 5'-nucleotidase activity in spermatozoa and seminal plasmaby using the spectrophotometer.
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 5 Dec 2017.
- Derived from this study: PubMed 31710193Alsalman 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.
- Individual participant dataSharing planned: Yes
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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.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Sulfate in people with Infertility Unexplained, 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 2 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 5 Dec 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.
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?
Measurement the uric acid level in spermatozoa and seminal plasma by using spectrophotometer. (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 NCT03361618, 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 5 Dec 2017.