Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers

Sponsor

Babylon University (Other)

Overall Status

Completed

CT.gov ID

NCT02217189

Collaborator

Ministry of Health, Iraq (Other)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Although several studies have considered the relationship between infertility and semen super oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on superoxide radical scavengers activity which are important in fertility of the individual has been reported.

Condition or Disease	Intervention/Treatment	Phase
Asthenozoospermia	Dietary Supplement: zinc sulfate	Phase 2

Detailed Description

The present study was conducted to study the effect of zinc supplementation on the quantitative and qualitative characteristics of semen along with superoxide radical scavengers activity in the seminal plasma of asthenospermic patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers in Spermatozoa of Patients With Asthenospermia

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zinc sulfate 60 subfertile (age 32.5±3.23 year) men with asthenozoospermia was treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).	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).
No Intervention: Healthy control 60 fertile (age 31.6±3.3 year) men, no treatment.

Arm

Intervention/Treatment

Experimental: Zinc sulfate

60 subfertile (age 32.5±3.23 year) men with asthenozoospermia was treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).

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).

No Intervention: Healthy control

60 fertile (age 31.6±3.3 year) men, no treatment.

Outcome Measures

Primary Outcome Measures

Oxido-sensitive index level in spermatozoa and seminal plasma. [up to three months.]

Secondary Outcome Measures

Volume of semen. [up to three months.]
Xanthine oxidase activity in spermatozoa and seminal plasma. [up to three months.]
Catalase like activity in spermatozoa and seminal plasma. [up to three months.]
Superoxide dismutase activity in spermatozoa and seminal plasma. [up to three months.]
Progressive sperm motility percentage. [up to three months]
Total normal sperm count. [up to three months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

26 Years to 36 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.