This study aimed to investigate the effect of therapeutic and antioxidant supplements on spermogram in infertile men with varicocele after varicocelectomy.The statistical population of this study includes all infertile men with clinical varicoceles who referred to Semnan Kosar Hospital in 2015-2016. evaluations including medical history, clinical examination, and at least two semen analyses .The participants were included in the study based on the inclusion and exclusion criteria. Incusion criteria: Full satisfaction from participation in the scheme;a medical history of primary or secondary infertility with at least one year of regular unprotected sexual intercourse. The exclusion criteria: Men have wives with ovulatory disorder (infertile); female infertility caused by pelvic disorders (endometriosis or adhesion). The sample is divided into two groups: Intervention group and control group. The patients were selected by single-blind balanced (permuted) block randomization method. Patients undergone a varicocelectomy repair with inguinal or sub inguinal approach. Intervention group received 200 mcg selenium supplements, 5mg folic acid and 400IU of vitamin E per day for 3to 6 months.Control group was given neither of the supplements. Based on statistical formula, there are 30 participants in each group. After 3 to 6 months of intervention, the results of spermogram and participants' fertility were analyzed and recorded on a researcher made checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091223855N2
Registration date:2015-10-29, 1394/08/07
Registration timing:na
Last update:
Update count:0
Registration date
2015-10-29, 1394/08/07
Registrant information
Name
Davood Arab
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 4042
Email address
drdavoodarab@semums.ac.ir
Recruitment status
Not enough for processing
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2015-09-21, 1394/06/30
Expected recruitment end date
empty
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplement therapy and antioxidant on spermogram in Varicocelectomized infertile men with varicoceles
Public title
effect of supplement therapy and antioxidant therapy on spermogram after varicocelectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with varicocele at least two semen fluid analysis done with the full consent for their participation in the project , and with a history of primary or secondary infertility for at least one year .
Exclusion criteria: patients who have a spouse with ovulatory dysfunction ( infertile ) and suspected infertility due to pelvic disorders ( endometriosis or adhesions there)
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Department of Medical Sciences, Basij Blvd, Semnan, Iran
City
Semnan
Postal code
Approval date
2015-08-25, 1394/06/03
Ethics committee reference number
IR.SEMUMS.REC.1394.71
Health conditions studied
1
Description of health condition studied
varicocele
ICD-10 code
186.1
ICD-10 code description
Scrotal varices
Primary outcomes
1
Description
spermogram
Timepoint
Before the intervention and after intervention
Method of measurement
Spermogram
Secondary outcomes
empty
Intervention groups
1
Description
Control group:after varicocellectomy the patients will be observed and wont recieved any drugs for 3-6 months .
Category
Treatment - Drugs
2
Description
Intervention group:After surgery, the Interventionl group will be treated with 200 micrograms of selenium supplementation per day and 5 mg of folic acid a day and 400 IU per day of antioxidant vitamin E for 3 to 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital Center
Full name of responsible person
Dr Davood Drab
Street address
Kosar Hospital, Basij BLVd, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor in Research Affairs(Semnan University of Medical Sciences)
Full name of responsible person
Dr Ali Rashidipour
Street address
Department of Medical Sciences, Basij Blvd, semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellor in Research Affairs(Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr Davood Arab
Position
Felloship of Endourology
Other areas of specialty/work
Street address
Kosar Hospital, Bassij Blvd,Semnan
City
Semnan
Postal code
Phone
+98 23 3343 7830
Fax
Email
drdavoodarab@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University Medical of Sciences
Full name of responsible person
Dr Davood Arab
Position
Felloship of Endourology
Other areas of specialty/work
Street address
Kosar Hospital, Blvd Bassij, Semnan
City
Semnan
Postal code
Phone
+98 23 3343 7830
Fax
Email
drdavoodarab@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Davood Drab
Position
Felloship of Endourology
Other areas of specialty/work
Street address
Kosar hospital, Bassij Blvd, Semnan
City
Semnan
Postal code
Phone
+98 23 3343 7830
Fax
Email
drdavoodarab@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)