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Protocol Registration Receipt 06t05t2012

tudy the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen (supplement) f lt is'*iil'J.i.'

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Sponsor: i mahmoud hussein hadwan

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Collaborators:

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Information provided

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mahmoud hussein hadwan, Babylon

University

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Purpose There are several causes leading to male infer1ility, like oxidative stress, and nutritional deficiency of trace elements like zinc. Zincin human seminal plasma was divided into three types of ligands which are high (HMW), intermediate (lMW), 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 asthenozoospmta.

; Condition

Intervention , Dietary Supplement: zinc sulfate

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Study Type: Observational

Study Design: Case-Control, Retrospective Official Title: Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen

:urther study details as provided by mahmoud hussein hadwan, Babylon University: Biospecimen Retention: None Retained

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Primary Outcome Measure: ' high molecular weight zinc binding protein frime Frame: at the end of three monthsl [Designated as safety issue: Yes] elevated levers of high morecurar weight zinc binding protein to normar varue Secondary Outcome Measures: ' qualitative semen parameters

[Time Frame: at the end of three months] [Designated as safety issue: yes] Volume of semen, progressive sperm motility percentage and total normal sperm count rncreased after zinc sulfate supplementation.

Enrollment: 37 Study Starl Date: July 2011 Study Completion Date: April2012

Primary Completion Dale: April 2012

Groups/Cohorts Single group

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

r Interventions

; Dietary Supplement: zinc sulfate :

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every participant took two capsules of zinc sulfate per O"y for three months (each one 22Omg) Other Names: inferlility

Elevation of RoS levels lead to an increase the oxidation of HMW-Zn binding proteins in seminal plasma of asthenozoospermic subjects. Zinc supplementation restores HMW-Zn% in seminal plasma of asthenozoospermic subjects to normal value. LMW-Zno/o is elevated in seminal plasma of asthenozoospermic pailents. lt may be because increment the levels of semenogelin in seminal plasrna of asthenozoospermic sub1ects. Zinc supplementation elevates LMW-Zn% in seminal plasma of asthenozoospermic subjects to more than normal value, this may be because of its enhancement of the synthesis of metallothioneins (Low molecular weight zinc binding protein).

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

Sampling Method: Non-Probability Sample Ages Eligible for Study: 27 years to 35 years Genders Eligible for Study: Male Inclusion Criteria: The inclusion criteria were the presence of asthenozoospermia rn the semen sampte. Exclusion Criteria:

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. the absence of endocrinopathy,

. varicocele, and ' female factor infefiility Smokers and alcoholic nren were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.

Contacts and Locations Locations lra q

Babylon university/ college of science Hilla, Hilla, lraq, lQ babylon university Hilla, Hilla, lraq, lQ ln

rroctinatnrq Principal Investigator

mahmoud H. hadwan, Dr.

babvlon universitv / lraq

More lnformation Responsible

Pa(y:

mahmoud hussein hadwan, Researcher, Babylon University

Study lD Numbers: babil-1 Health

Authority:

lraq: Ethics Committee

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