Clinical trial NCT01684059: Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway
Official title: Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthenozoospermia
Lead sponsor: Babylon University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Iraq
First posted: 2012-09-12
Enrollment: 60
Sex: MALE
Minimum age (years): 27
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: this study includes 60 fertile male partners from couples who had consulted the infertility clinic of babil hospital of maternity (Hilla city/ IRAQ).

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Nitric oxide synthase activity
timeFrame: at the end of three months
Secondary outcomes:
measure: Arginase activity
timeFrame: at the end of three months
Other outcomes:
Locations:
city: Hilla
country: Iraq
facility: Babylon university/ college of science
Study officials:
affiliation: babylon university / Iraq
name: mahmoud H. hadwan, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Babylon university/Iraq
name: Lamia A. Almashhedy, phD
role: STUDY_CHAIR
affiliation: Babylon university/Iraq
name: abdulrrazaq S. Alsalman, phD
role: STUDY_DIRECTOR
References:
citation: Hadwan MH, Almashhedy LA, Alsalman AR. Study of the effects of oral zinc supplementation on peroxynitrite levels, arginase activity and NO synthase activity in seminal plasma of Iraqi asthenospermic patients. Reprod Biol Endocrinol. 2014 Jan 3;12:1. doi: 10.1186/1477-7827-12-1.