NCT01612403

Brief Summary

There are several causes leading to male infertility, like oxidative stress, and nutritional deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands (LMW). The present study was conducted to study the effect of Zn supplementation on the quantitative and qualitative characteristics of semen along with Zinc Binding Protein levels 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
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

9 months

First QC Date

June 1, 2012

Last Update Submit

June 5, 2012

Conditions

Keywords

zinc binding protein

Outcome Measures

Primary Outcomes (1)

  • high molecular weight zinc binding protein

    elevated levels of high molecular weight zinc binding protein to normal value

    at the end of three months

Secondary Outcomes (1)

  • qualitative semen parameters

    at the end of three months

Study Arms (1)

Single group

Single group: all participants receive same intervention throughout study (Non-randomised)

Dietary Supplement: zinc sulfate

Interventions

zinc sulfateDIETARY_SUPPLEMENT

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

Also known as: infertility
Single group

Eligibility Criteria

Age27 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study includes 37 subfertile male partners from couples who had consulted the infertility clinic of the Babil hospital of maternity (Hilla city/ IRAQ).

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 (2)

Babylon university/ college of science

Hillah, Hilla, IQ, Iraq

Location

Babylon University

Hillah, Hilla, IQ, Iraq

Location

Related Publications (1)

  • Hadwan MH, Almashhedy LA, Alsalman AR. Oral zinc supplementation restores high molecular weight seminal zinc binding protein to normal value in Iraqi infertile men. BMC Urol. 2012 Nov 13;12:32. doi: 10.1186/1471-2490-12-32.

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, Dr.

    babylon university / Iraq

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 1, 2012

First Posted

June 5, 2012

Study Start

July 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations