Varicocele is a common disease of male genital organ that may cause subfertility or infertility. Folic acid and zinc sulfate have been introduced as treatments in the case of subfertility in infertility causative factors other than varicocele. Our aim of this study is to investigate the probable effects of folic acid and zinc sulfate on semen quality and fertility status of male subjects undergoing varicocelectomy. One hundred Patients suffering from varicocele will be randomly divided to four groups of 25 patients each. Patients will receive appropriate surgery to correct the varicocele. Following varicocelectomy, Patients will receive zinc sulfate, folic acid, zinc sulfate and folic acid, or placebo respectively. Patients with a history of Diabetes, high blood pressure and cancer of testis will be excluded. Hormonal status (Tetosterone, FSH and Inhibin), semen and sperm parameters, and the level of NO and SOD will be evaluated before the intervention, three and six months later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802261910N1
Registration date:2009-09-26, 1388/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-09-26, 1388/07/04
Registrant information
Name
Seyed Noureddin Nematollahi Mahani
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 1666
Email address
nnematollahi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Science
Expected recruitment start date
2008-02-29, 1386/12/10
Expected recruitment end date
2009-12-28, 1388/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Zinc sulfate and Folic acid administration on semen quality and some sex hormones in varicocelectomized men
Public title
Effect of zinc and folic acid on male reproduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Men with a history of varicocele. Exclusion criteria: Men with a history of cancer of testis, high blood pressure (systolic blood pressure >140 mmHg), or diabetes.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Science
Street address
Tahmasb abad cross, chancelor in research
City
kerman
Postal code
Approval date
2006-01-25, 1384/11/05
Ethics committee reference number
K/85/64
Health conditions studied
1
Description of health condition studied
varicocele
ICD-10 code
I86.1
ICD-10 code description
Scrotal varices
2
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Change in sex hormone
Timepoint
Before intervention, 3 mo, and 6 mo after intervention
Method of measurement
Evaluation of hormones by ELIZA
2
Description
Quality of semen
Timepoint
Before intervention, 3 mo, and 6 mo after intervention
Method of measurement
sperm analysis
Secondary outcomes
1
Description
Change in fertility status
Timepoint
1 y
Method of measurement
Rise in hCG/ sonographic evaluation
Intervention groups
1
Description
Folic acid Capsules 5 mg/day, orally plus Zinc sulfate 50 mg/day orally for six months
Category
Treatment - Drugs
2
Description
Zinc sulfate Capsules 50 mg/day, orally plus placebo capsules with the same dose and shape as Folic acid capsules for 6 months
Category
Treatment - Drugs
3
Description
Folic acid Capsules 5 mg/day, orally plus placebo capsules with the same dose and shape as Zinc sulfate capsules for 6 months
Category
Treatment - Drugs
4
Description
Placebo capsules filled with starch with the same dose and shape as active drugs (Folic acid and Zinc sulfate capsules) for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital/ private clinic
Full name of responsible person
A Azizollahi, MD.
Street address
City
kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
H Najafipour, Ph.D.
Street address
Tahmasb abad Cross
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Seyed Noureddin Nematollahi-mahani
Position
Ph.D/ Academic staff
Other areas of specialty/work
Street address
Department of anatomy, Afzalipour school of medicine
City
Kerman
Postal code
Phone
+98 34 1322 1666
Fax
Email
nnematollahi@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Seyed Noureddin Nematollahi-mahani
Position
Associate prof/Ph.D.
Other areas of specialty/work
Street address
Department of anatomy, Afzalipour school of medicine
City
Kerman
Postal code
Phone
+98 34 1322 1666
Fax
Email
nnematollahi@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Seyed Noureddin Nematollahi-mahani
Position
Associate profesor/Ph.D.
Other areas of specialty/work
Street address
City
Postal code
7616914111
Phone
+98 34 1322 1666
Fax
Email
nnematollahi@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)