Comparison of the effects of treatment with recombinant human follicle stimulating hormone (rhFSH), human chorionic gonadotropin (HCG) and human menopausal gonadotropin (HMG) on semen parameters after varicocelectomy in patients with varicocele
Our study aim, for the first time, to compare the efficacy of recombinant human follicle-stimulating hormone (rhFSH), human chorionic gonadotropin (HCG) and human menopausal gonadotropin (HMG) on sperm parameters and fertility after varicocelectomy. This study is designed as a multicenter, double blind, randomized clinical trial. the major inclusion criteria is male factor infertility due to varicocele and the major exclusion criteria are underlying testis abnormalities and abnormal reproductive hormone levels.One-hundred twenteen patients who will referred to the Fertility and Infertility Research Center of Hamadan University of Medical Sciences and the Urology and Nephrology Research Center of Shahid Beheshti University of Medical Sciences will be divided into four groups considering the similarity and randomization to treat for three months with recombinant human follicle-stimulating hormone, human chorionic gonadotropin and human menopausal gonadotropin and no medical treatment after varicocelectomy. finally sperm parameters and fertility in all groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112248509N1
Registration date:2012-01-06, 1390/10/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-06, 1390/10/16
Registrant information
Name
Nasibeh Amirzargar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 0582
Email address
n-amirzargar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center of Shahid Beheshti University of Medical Sciences
Fertility and Infertility Research Center of Hamadan University of Medical Sciences
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of treatment with recombinant human follicle stimulating hormone (rhFSH), human chorionic gonadotropin (HCG) and human menopausal gonadotropin (HMG) on semen parameters after varicocelectomy in patients with varicocele
Public title
The effect of treatment with recombinant human follicle stimulating hormone (rhFSH), human chorionic gonadotropin (HCG) and human menopausal gonadotropin (HMG) on semen parameters after varicocelectomy: a randomized clinical trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infertility after 12 months of unprotected intercourse; male factor infertility due to varicocele; spontaneous onset of maturation and normal sexual development
Exclusion criteria: presence of infertility due to any other factor especially female infertility; systemic disease; underlying testis abnormalities; abnormal reproductive hormone levels.
Age
No age limit
Gender
Male
Phase
N/A
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urology and Nephrology Research Center (UNRC), Shahid Labbafinejad Medical Center
Street address
labafinejhad hospital
City
tehran
Postal code
Approval date
2007-06-23, 1386/04/02
Ethics committee reference number
118-م-ت-الف
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
sperm parameters
Timepoint
before initiation of treatment and further control examinations were performed 8 to 10 weeks after the completion of each period of treatment
Method of measurement
spermogram
Secondary outcomes
1
Description
pregnancy
Timepoint
6 month
Method of measurement
bHCG
Intervention groups
1
Description
Patients will be treated with 5000 IU human chorionic gonadotropin weekly intramuscular for 3 months.
Category
Treatment - Drugs
2
Description
Patients will be treated with 75 IU human menopausal gonadotropin three times a week sub coutaneous for 3 months.
Category
Treatment - Drugs
3
Description
Patients will be treated with 75 IU recombinant human follicle-stimulating hormone three times a week sub coutaneous for 3 months.
Category
Treatment - Drugs
4
Description
no medical treatment after varicocelectomy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fertility and Infertility Research Center of Hamadan University of Medical Sciences
Full name of responsible person
Street address
City
hamadan
2
Recruitment center
Name of recruitment center
Urology and Nephrology Research Center of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Street address
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology and Nephrology Research Center of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbass Basiri
Street address
Urology and Nephrology Research Center, Shahid Labbafinejad Medical Hospital, Pasdaran avenue, Tehran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology and Nephrology Research Center of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Ali Amirzargar
Street address
Urology Department, Hamadan University of Medical Sciences, University square, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences
Proportion provided by this source
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
Department of Urology, Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Ali Amirzargar
Position
urologist
Other areas of specialty/work
Street address
Urology Department, Hamadan University of Medical Sciences, University square, Hamadan
City
hamadan
Postal code
Phone
+98 81 1823 2858
Fax
Email
dr_amirzargar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Urology, Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Ali Amirzargar
Position
urologist
Other areas of specialty/work
Street address
Urology Department, Hamadan University of Medical Sciences, University square, Hamadan
City
hamadan
Postal code
Phone
+98 81 1823 2858
Fax
Email
dr_amirzargar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mohammad Ali Amirzargar
Position
Other areas of specialty/work
Street address
Urology Department, Hamadan University of Medical Sciences, University square, Hamadan
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)