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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02985905
Other study ID # Babil-4
Secondary ID
Status Completed
Phase Phase 2
First received December 2, 2016
Last updated December 6, 2016
Start date July 2011
Est. completion date July 2012

Study information

Verified date December 2016
Source Babylon University
Contact n/a
Is FDA regulated No
Health authority Iraq: Ethics Committee
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 26 Years to 36 Years
Eligibility Inclusion Criteria:

- The presence of asthenozoospermia in the semen sample.

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
zinc 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).

Locations

Country Name City State
Iraq Mahmoud Hadwan Hilla Babylon

Sponsors (2)

Lead Sponsor Collaborator
mahmoud hussein hadwan Ministry of Health, Iraq

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to three months. Yes
Secondary 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. up to three months. Yes
Secondary 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. up to three months. Yes
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