NCT02985905

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

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
4.4 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 2, 2016

Last Update Submit

December 6, 2016

Conditions

Keywords

Zinc supplementationThiolGlutathione peroxidaseSulfhydryl oxidase

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to three months.

Secondary Outcomes (2)

  • 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.

    up to three months.

  • 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.

    up to three months.

Study Arms (2)

Zinc sulfate

EXPERIMENTAL

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

Healthy control

NO INTERVENTION

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

Interventions

zinc sulfateDIETARY_SUPPLEMENT

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

Zinc sulfate

Eligibility Criteria

Age26 Years - 36 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Mahmoud Hadwan

Hillah, Babylon, 51002, Iraq

Location

Related Publications (1)

  • 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.

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 Hadwan, PhD

    Babylon University

    PRINCIPAL INVESTIGATOR
  • L Almashhedy, PhD

    Babylon University

    STUDY DIRECTOR
  • Alsalman Abdulrrazaq, PhD

    Babylon University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 7, 2016

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 7, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

I plan to publish the results in a scientific journal

Locations