The effect of recombinant follicle-stimulating hormone (rFSH) on semen parameters after varicocelectomy in infertile men referring to the Comprehensive Women's Hospital (Mohebe-Yas) since September 2014 to September 2015
This study is an interventional, randomized clinical trial. The purpose of this study was to evaluate the effects of rFSH on semen parameters after varicocelectomy in infertile men. Infertile men who referred to Moheb-Yas hospital and undergoing varicocelectomy were enrolled to this study Conveniently. Semen parameters were measured for all patients. The patients were randomly divided into two groups. One group was treated with subcutaneous Recombinant FSH and the second group received placebo with the same method. Treatment was done 3 times a week for a period of 3 months. After 3 months, the rate of improvement in semen parameters including Motility, morphology, and Count and side effects were determined and compared in both groups. Finally data were statistically analyzed by SPSS version 13.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061522757N1
Registration date:2015-06-22, 1394/04/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-22, 1394/04/01
Registrant information
Name
Atoosa Bagheri behzad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4216 0852
Email address
atoosa.bagheribehzad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of recombinant follicle-stimulating hormone (rFSH) on semen parameters after varicocelectomy in infertile men referring to the Comprehensive Women's Hospital (Mohebe-Yas) since September 2014 to September 2015
Public title
Effect of Recombinant FSH on infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: varicocelectomy for unilateral idiopathic varicocele; Age 20 to 40 years; patient consent
Exclusion criteria: lack of consent; being allergic to pharmaceutical composition
Age
From 20 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of medical siences
Street address
14155 Poursina St- Keshavarz Blvd
City
Tehran
Postal code
14155-5583
Approval date
2015-01-03, 1393/10/13
Ethics committee reference number
9121290002-133624
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 count
Timepoint
After varicocelectomy before treatment and 3 months after treatment
Method of measurement
According semen analusis
2
Description
Sperm motility
Timepoint
After varicocelectomy before treatment and 3 months after treatment
Method of measurement
According semen analusis
3
Description
Sperm morphology
Timepoint
After varicocelectomy before treatment and 3 months after treatment
Method of measurement
According semen analusis
Secondary outcomes
1
Description
Complications
Timepoint
During the three-month period of treatment
Method of measurement
According case history
Intervention groups
1
Description
Injection Follitropin / Rcombinant FSH subcutaneously - 75 units / 0.5 ml in the intervention group
Category
Treatment - Drugs
2
Description
Injection Normal Saline subcutaneously - 0.5 ml in control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohebe-Yas hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Mahbod Ebrahimi
Street address
14155 Poursina St- Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran university of medical sciences
Full name of responsible person
Dr. Atoosa Bagheri Behzad
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
North Nejat-alahi St-Karim Khan zand Ave
City
Tehran
Postal code
Phone
+98 21 4216 0852
Fax
Email
Atoosa.bagheribehzad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Mahbod Ebrahimi
Position
Fellowship of infertility
Other areas of specialty/work
Street address
North Nejat-alahi St-Karim Khan zand Ave
City
Tehran
Postal code
Phone
+98 21 4216 0852
Fax
Email
maeb@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university off medical sciences
Full name of responsible person
Dr. Atoosa Bagheri Behzad
Position
Resident of Gynecology and Obstetrics
Other areas of specialty/work
Street address
North Nejat-alahi St-Karim Khan zand Ave
City
Tehran
Postal code
Phone
+98 21 4216 0852
Fax
Email
Atoosa.bagheribehzad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)