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The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index

Primary Purpose

Asthenozoospermia

Status

Completed

Phase

Phase 2

Locations

Iraq

Study Type

Interventional

Intervention

zinc sulfate

About this trial

This is an interventional treatment trial for Asthenozoospermia focused on measuring Zinc supplementation, Thiol, Glutathione peroxidase, Sulfhydryl oxidase

Eligibility Criteria

26 Years - 36 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Mahmoud Hadwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Zinc sulfate

Healthy control

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02985905

First Posted

December 2, 2016

Last Updated

December 6, 2016

Sponsor

mahmoud hussein hadwan

Collaborators

Ministry of Health, Iraq

1. Study Identification

Unique Protocol Identification Number

NCT02985905

Brief Title

The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index

Official Title

The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index and Thiol Related Enzymes in Spermatozoa of Iraqi Asthenospermic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

mahmoud hussein hadwan

Collaborators

Ministry of Health, Iraq

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthenozoospermia

Keywords

Zinc supplementation, Thiol, Glutathione peroxidase, Sulfhydryl oxidase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zinc sulfate

Arm Type

Experimental

Arm Description

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).

Arm Title

Healthy control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

zinc sulfate

Intervention Description

The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).

Primary Outcome Measure Information:

Title

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.

Time Frame

up to three months.

Secondary Outcome Measure Information:

Title

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.

Time Frame

up to three months.

Title

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.

Time Frame

up to three months.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

26 Years

Maximum Age & Unit of Time

36 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahmoud Hadwan, PhD

Organizational Affiliation

Babylon University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

L Almashhedy, PhD

Organizational Affiliation

Babylon University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Alsalman Abdulrrazaq, PhD

Organizational Affiliation

Babylon University

Official's Role

Study Chair

Facility Information:

Facility Name

Mahmoud Hadwan

City

Hilla

State/Province

Babylon

ZIP/Postal Code

51002

Country

Iraq

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

I plan to publish the results in a scientific journal

Citations:

PubMed Identifier

29222649

Citation

Alsalman ARS, Almashhedy LA, Hadwan MH. Effect of Oral Zinc Supplementation on the Thiol Oxido-Reductive Index and Thiol-Related Enzymes in Seminal Plasma and Spermatozoa of Iraqi Asthenospermic Patients. Biol Trace Elem Res. 2018 Aug;184(2):340-349. doi: 10.1007/s12011-017-1215-8. Epub 2017 Dec 8.

Results Reference

derived

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The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index

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