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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01684059
Other study ID # Babil-2
Secondary ID
Status Completed
Phase N/A
First received September 9, 2012
Last updated September 11, 2012
Start date July 2011
Est. completion date July 2012

Study information

Verified date September 2012
Source Babylon University
Contact n/a
Is FDA regulated No
Health authority Iraq: Ethics Committee
Study type Observational

Clinical Trial Summary

The ability of spermatozoa to produce reactive oxygen species (ROS) has been respected since the 1940's. Oxidative stress limits the functional competence of mammalian spermatozoa via lipid peroxidation, the induction of oxidative DNA damage and the formation of protein adducts. Nitric oxide (NO) is a free radical generated from the oxidation of L-arginine to L-citrulline by reduced nicotinamide adenine dinucleotide phosphate (NADPH)-dependent NO synthases. Several studies suggest that the overproduction of this free radical and the subsequent excessive exposure to oxidative conditions have a potential pathogenetic implication, which due to the reduction of sperm motility. The present study was conducted to study the effect of Zn supplementation on the levels of NO synthase and arginase in semen of patients with asthenozoospmia.


Description:

Previous studies suggest that high concentrations of NO play an injurious consequence on spermatozoa kinetic characteristics. These studies reported that NO may react with superoxide or hydrogen peroxide, resulting in the production of peroxinitrite, hydroxyl radical, or singlet oxygen, which cause oxidation of sperm membrane lipids and thiol proteins. NO also may inhibit cellular respiration by nitro-sylation of heme in mitochondrial enzymes, aconitase, and glyceraldehyde phosphate dehydrogenase, leading to a reduction of adenosine triphosphate and that is due to loss of motility of spermatozoa.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Male
Age group 27 Years to 35 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

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
zinc sulfate
every participant took two capsules of zinc sulfate per day for three months (each one 220mg)

Locations

Country Name City State
Iraq Babylon university/ college of science Hilla

Sponsors (2)

Lead Sponsor Collaborator
Babylon University Ministry of health/Iraq

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nitric oxide synthase activity at the end of three months Yes
Secondary Arginase activity at the end of three months Yes
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