NCT01684059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

1 year

First QC Date

September 9, 2012

Last Update Submit

September 11, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Nitric oxide synthase activity

    at the end of three months

Secondary Outcomes (1)

  • Arginase activity

    at the end of three months

Study Arms (1)

Single group

Single group: each participant receive same intervention (zinc sulfate) throughout study (non-randomized)

Dietary Supplement: zinc sulfate

Interventions

zinc sulfateDIETARY_SUPPLEMENT

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

Single group

Eligibility Criteria

Age27 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • the presence of asthenozoospermia in the semen sample.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babylon university/ college of science

Hillah, Hilla, IQ, Iraq

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Asthenozoospermia

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • mahmoud H. hadwan, phD

    babylon university / Iraq

    PRINCIPAL INVESTIGATOR
  • Lamia A. Almashhedy, phD

    Babylon university/Iraq

    STUDY CHAIR
  • abdulrrazaq S. Alsalman, phD

    Babylon university/Iraq

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phD

Study Record Dates

First Submitted

September 9, 2012

First Posted

September 12, 2012

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 12, 2012

Record last verified: 2012-09

Locations