NCT03361618

Brief Summary

Although many reports have investigated the relationship between subfertility and uric acid levels in semen, to the best of author knowledge, there is no study have been published to yet focus on the effects of asthenospermia treatments, such as given an oral zinc supplementation, on the activity of urate-related enzymes, which are important in fertility of human.

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 not_applicable

Timeline
Completed

Started Jul 2011

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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

November 7, 2017

Last Update Submit

December 4, 2017

Conditions

Infertility Unexplained

Keywords

Uric acidAdenosine deaminaseZinc Sulfate5'-nucleotidaseAsthenospermia.Xanthine oxidase

Outcome Measures

Primary Outcomes (1)

  • Measurement the uric acid level in spermatozoa and seminal plasma by using spectrophotometer.

    Clinical parameter

    up to three months.

Secondary Outcomes (3)

  • Measurement the adenosine deaminase activity in spermatozoa and seminal plasma by using spectrophotometer.

    up to three months.

  • Measurement the xanthine oxidase activity in spermatozoa and seminal plasma by using spectrophotometer.

    up to three months.

  • Measurement the 5'-nucleotidase activity in spermatozoa and seminal plasmaby using the spectrophotometer.

    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(Gender-based eligibility)
Gender Eligibility DetailsMale that undergo the presence of asthenozoospermia in the semen sample.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The presence of asthenozoospermia in the semen sample.
  • Must be unable to reproduce.

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 Hussein Hadwan

Hillah, Babylon, 51002, Iraq

Location

Related Publications (1)

  • Alsalman ARS, Almashhedy LA, Alta'ee AH, Hadwan MH. Effect of Zinc Supplementation on Urate Pathway Enzymes in Spermatozoa and Seminal Plasma of Iraqi Asthenozoospermic Patients: A Randomized Controlled Trial. Int J Fertil Steril. 2020 Jan;13(4):315-323. doi: 10.22074/ijfs.2020.5760. Epub 2019 Nov 11.

    PMID: 31710193DERIVED

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

  • Abdul Razzaq A. Alsalman, PhD

    University of Babyblon

    STUDY CHAIR

  • Lamia A. Almashhedy, PhD

    University of Babyblon

    STUDY DIRECTOR

  • Mahmoud Hussein Hadwan, PhD

    University of Babyblon

    PRINCIPAL INVESTIGATOR

  • Abdulsamie H Alta'ee, PhD

    University of Babyblon

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Semen volume after treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Dr. Mahmoud Hussein Hadwan

Study Record Dates

First Submitted

November 7, 2017

First Posted

December 5, 2017

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 5, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will share

Locations

IR(1)