AsthenozoospermiasupplementNCT01612403
Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen
An observational study of Asthenozoospermia, run by mahmoud hussein hadwan at 2 sites in Iraq.
Trial summary
There are several causes leading to male infertility, like oxidative stress, and nutritional deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands (LMW). Read more about this study
- Who is it for?
- Ages 27 to 35 years, men only
- Conditions the study is for
- Asthenozoospermia
- What is being tested?
- zinc sulfate
- Type of treatment
- Pill or oral medicine
- How many people
- 37 participants
- Where
- 2 sitesIraq
- Study dates
- Jul 2011to Apr 2012
- Phase
- Observational
- 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 27 to 35 years
- Men only
- No healthy volunteers
- Adult
Study population: This study includes 37 subfertile male partners from couples who had consulted the infertility clinic of the Babil hospital of maternity (Hilla city/ IRAQ).
Who may be able to join
- The inclusion criteria were 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
2 sites in 1 country.
Iraq2 sites
Babylon university/ college of science
Hillah, Hilla, IQ
Babylon University
Hillah, Hilla, IQ
About this study
There are several causes leading to male infertility, like oxidative stress, and nutritional deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands (LMW). The present study was conducted to study the effect of Zn supplementation on the quantitative and qualitative characteristics of semen along with Zinc Binding Protein levels in semen of patients with asthenozoospmia.
Read the detailed description
Elevation of ROS levels lead to an increase the oxidation of HMW-Zn binding proteins in seminal plasma of asthenozoospermic subjects. Zinc supplementation restores HMW-Zn% in seminal plasma of asthenozoospermic subjects to normal value. LMW-Zn% is elevated in seminal plasma of asthenozoospermic patients. It may be because increment the levels of semenogelin in seminal plasma of asthenozoospermic subjects. Zinc supplementation elevates LMW-Zn% in seminal plasma of asthenozoospermic subjects to more than normal value, this may be because of its enhancement of the synthesis of metallothioneins (Low molecular weight zinc binding protein).
- Conditions
- Asthenozoospermia
- Being tested
- zinc sulfate
- Keywords
- zinc binding protein
- 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
Also called infertility
every participant took two capsules of zinc sulfate per day for three months (each one 220mg)
| Study group | Role | What they receive |
|---|---|---|
| Single group | Single group: all participants receive same intervention throughout study (Non-randomised) Receives: Dietary Supplement: zinc sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
high molecular weight zinc binding protein
elevated levels of high molecular weight zinc binding protein to normal value
Measured: at the end of three months
Secondary outcomes (1)
qualitative semen parameters
Volume of semen, progressive sperm motility percentage and total normal sperm count increased after zinc sulfate supplementation.
Measured: at the end of 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 Jun 2012 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionApr 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- mahmoud hussein hadwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mahmoud hussein hadwan, Babylon University
- Investigators
- mahmoud H. hadwan, Dr., Principal investigator, babylon university / Iraq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612403
- Sponsor's protocol ID
- babil-1
- Acronym
- supplement
- Status last verified
- Jun 2012
- First submitted
- 1 Jun 2012
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hadwan MH, Almashhedy LA, Alsalman AR. Oral zinc supplementation restores high molecular weight seminal zinc binding protein to normal value in Iraqi infertile men. BMC Urol. 2012 Nov 13;12:32. doi: 10.1186/1471-2490-12-32.
PubMed 23145537
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen
- ClinicalTrials.gov ID
- NCT01612403
- Acronym / sponsor ID
- supplement / babil-1
- Conditions
- Asthenozoospermia
- Keywords
- zinc binding protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- mahmoud hussein hadwanUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 Jun 2012 (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.
There are several causes leading to male infertility, like oxidative stress, and nutritional deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands (LMW). The present study was conducted to study the effect of Zn supplementation on the quantitative and qualitative characteristics of semen along with Zinc Binding Protein levels in semen of patients with asthenozoospmia.
Detailed description
Elevation of ROS levels lead to an increase the oxidation of HMW-Zn binding proteins in seminal plasma of asthenozoospermic subjects. Zinc supplementation restores HMW-Zn% in seminal plasma of asthenozoospermic subjects to normal value. LMW-Zn% is elevated in seminal plasma of asthenozoospermic patients. It may be because increment the levels of semenogelin in seminal plasma of asthenozoospermic subjects. Zinc supplementation elevates LMW-Zn% in seminal plasma of asthenozoospermic subjects to more than normal value, this may be because of its enhancement of the synthesis of metallothioneins (Low molecular weight zinc binding protein).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Dietary Supplement: zinc sulfateSingle group: all participants receive same intervention throughout study (Non-randomised) |
Who may qualify
- Ages
- 27 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study includes 37 subfertile male partners from couples who had consulted the infertility clinic of the Babil hospital of maternity (Hilla city/ IRAQ).
Key inclusion criteria (1 listed)
- The inclusion criteria were the presence of asthenozoospermia in the semen sample.
Key exclusion criteria (3 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 sulfateAlso: infertilityevery participant took two capsules of zinc sulfate per day for three months (each one 220mg) | Dietary supplement | Single group |
Primary outcome
high molecular weight zinc binding protein
Time frame: at the end of three months
elevated levels of high molecular weight zinc binding protein to normal value
1 secondary outcome
qualitative semen parameters
Time frame: at the end of 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 6 Jun 2012.
- Derived from this study: PubMed 23145537Hadwan MH, Almashhedy LA, Alsalman AR. Oral zinc supplementation restores high molecular weight seminal zinc binding protein to normal value in Iraqi infertile men. BMC Urol. 2012 Nov 13;12:32. doi: 10.1186/1471-2490-12-32.
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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.
mahmoud H. hadwan, Dr. principal investigator
babylon university / Iraq
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthenozoospermia, run by mahmoud hussein hadwan at 2 sites 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 3 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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
high molecular weight zinc binding protein (time frame: at the end of 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 NCT01612403, 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 6 Jun 2012.