Objective: To study the effects of zinc sulfate treatment on semen variables in fertile and subfertile men.
Design: Double-blind, placebo-controlled interventional study.
Setting: The study comprised one hundred twenty sub fertile men who referred Akbar Abadi hospital, infertility center and one outpatient infertility clinic, Tehran, Iran.
Intervention(s): total sperm count in these patients is 5000000 to 20000000; also we measured plasma zinc and semen zinc concentration. Patients were randomly allocated to treatment with Zinc supplement (n = 60) was given 10 ml three times a day and placebo (n = 60) with the same order. After three months we will recheck sperm count and plasma zinc and semen zinc and will analyzed them. Main inclusion criteria: subfertile men with sperm concentration 5000000 to 20000000; main exclusion criteria: known chromosomal abnormality related to infertility.
Main Outcome Measure(s): sperm concentration, plasma zinc, semen zinc.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041120923N2
Registration date:2016-01-18, 1394/10/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-18, 1394/10/28
Registrant information
Name
Fatemeh Sharifzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4426 0431
Email address
sharifzadeh.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of zinc supplement on spermogeram of sub fertile men.
Public title
Zink supplement effect on sperm count.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Subfertile men as defined failure of the female partner to conceive after 1 year of regular, unprotected intercourse; sperm concentration of 5 and 20 million on the semen analysis.
Exclusion criteria: Abnormal endocrine screening(hypo or hyper thyroidemia); Men with chromosomal disorder such as Y chromosome deletions; use of zinc or other supplements in the 3 months before recruitment.
Age
From 20 years old to 50 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
sealed envelope
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-07-21, 1394/04/30
Ethics committee reference number
IR.IUMS.REC.1394.26155
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Male Infertility
Primary outcomes
1
Description
Sperm Concentration
Timepoint
Prior to intervention, 3 monthes after intervention
Method of measurement
Sperm Analysis, Million/ml
2
Description
Serum Zinc
Timepoint
Prior to intervention, 3 monthes after intervention
Method of measurement
Serum Biochemistry Test/ Micro gr/ dl
3
Description
Semen Zinc
Timepoint
Prior to intervention, 3 monthes after intervention
Method of measurement
Semen Biochemistry Test, mg/dl
Secondary outcomes
1
Description
Sperm Morphology
Timepoint
Prior to intervention, 3 months after intervention
Method of measurement
Sperm Analysis, Percent
2
Description
Sperm Motility
Timepoint
Prior to intervention, 3 monthes after intervention
Method of measurement
Sperm Analysis, Percent
Intervention groups
1
Description
Intervention group 2: Water Soluble/ 10 cc/ 3 times a day
Category
Placebo
2
Description
Intervention group 1: Zinc Soluble Alhavi, 0.5%/ 10cc/ 3 times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar Abadi Infertility Center
Full name of responsible person
Sara Norouzi
Street address
Shahid Akbar Abadi Hospital, Molavi Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Of Iran University of Medical Sciences
Full name of responsible person
Dr Seid Ali Javad Mousavi
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Norouzi
Position
resident of obstetrician & gynecology
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Postal code
Phone
+98 21 4426 0421
Fax
Email
Sr.norouzi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr Fatemeh Sharifzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Akbar Abadi Hospital, Molavi Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4426 0421
Fax
Email
Sharifzadeh.f@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Norouzi
Position
resident of obstetrician & gynecology
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8830 6866
Fax
Email
Sr.norouzi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)