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Comparison of the effect of treatment with HCG and recombinant human FSH versus not treatment on improvement of semen parameters in infertile men after surgical repair of varicocele: a randomized clinical trial

Protocol summary

Summary
Objectives: To compare the effect of treatment with HCG and recombinant human FSH on improvement of semen parameters in infertile men after surgical repair of varicocele. Design:A randomized clinical trial. Setting and conduct:All infertile females who will refer to infertility clinics of Hamadan City during 2012 and 2013. Participants including major eligibility criteria: The inclusion criteria are: (a) having unilateral or bilateral palpable varicocele; (b) history of infertility for at least one-year; (c) having healthy wife; having abnormal spermogram. The exclusion criteria are: (a) having no testis in scrotum; (b) having acute urogenital infection; (c) medical history of abnormal function of testis such as: trauma, torsion, cryptorchidism, vas deferens obstruction, abnormal karyotype, diabetes, chemotherapy, any history of surgical treatment on testis, scrotum or pituitary gland; (d) contraindication of FSH such as high level of FSH in serum or uncontrolled dysfunction of thyroid or adrenal glands; (e) BMI>40; (f) substance abuse such as alcohol, narcotics, or anabolic asteroids; (g) testis smaller than 4 mL in ultrasonography; (h) azoospermia (no spermatozoid); (i) using gonadotropin. Intervention:The intervention group will be undergone varicocelectomy and then will receive 75 IU recombinant human FSH subcutaneously three times a week and 5000 IU HCG intramuscularly once a week for three months. The control group will be undergone varicocelectomy only. Main outcome measures: The outcome of interest is improvement of the semen parameters including concentration (106/mm2), motility (%), and morphology (%) of spermatozoid after three months as well as the increase in the rate of pregnancy and decrease in the duration of waiting time for pregnancy after one year.

General information

Acronym
HCG: Human Chorionic Gonadotropin FSH: Follicle Stimulating Hormone
IRCT registration information
IRCT registration number: IRCT201203039014N3
Registration date: 2012-04-25, 1391/02/06
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-04-25, 1391/02/06
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-05-21, 1392/02/31
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison of the effect of treatment with HCG and recombinant human FSH versus not treatment on improvement of semen parameters in infertile men after surgical repair of varicocele: a randomized clinical trial
Public title
Comparison of the effect of treatment with HCG and recombinant human FSH versus not treatment on improvement of semen parameters in infertile men after surgical repair of varicocele
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: (a) having unilateral or bilateral palpable varicocele; (b) history of infertility for at least one-year; (c) having healthy wife; having abnormal spermogram. Exclusion criteria are: (a) having no testis in scrotum; (b) having acute urogenital infection; (c) medical history of abnormal function of testis such as: trauma, torsion, cryptorchidism, vas deferens obstruction, abnormal karyotype, diabetes, chemotherapy, any history of surgical treatment on testis, scrotum or pituitary gland; (d) contraindication of FSH such as high level of FSH in serum or uncontrolled dysfunction of thyroid or adrenal glands; (e) BMI>40; (f) substance abuse such as alcohol, narcotics, or anabolic asteroids; (g) testis smaller than 4 mL in ultrasonography; (h) azoospermia (no spermatozoid); (i) using gonadotropin.
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Local Human Subject Review board
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Approval date
2012-04-22, 1391/02/03
Ethics committee reference number
D/P/16/35/9/246

Health conditions studied

1

Description of health condition studied
Male infertility due to varicocele
ICD-10 code
N46
ICD-10 code description
Male infertility

Primary outcomes

1

Description
The outcome of interest is improvement of the semen parameters including concentration (106/mm2), motility (%), and morphology (%) of spermatozoid.
Timepoint
Three months
Method of measurement
Laboratory tests

Secondary outcomes

1

Description
The secondary outcome of interest is the increase in the rate of pregnancy and decrease in the duration of waiting time for pregnancy.
Timepoint
One year
Method of measurement
History taking

Intervention groups

1

Description
The intervention group will be undergone varicocelectomy and then will receive 75 IU recombinant human FSH subcutaneously three times a week and 5000 IU HCG intramuscularly once a week for three months.
Category
Treatment - Drugs

2

Description
The control group will be undergone varicocelectomy only without hormone therapy.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Beasat Hospitals
Full name of responsible person
Dr Mohammad Ali Amirzargar
Street address
Shahed Ave.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Ahmad Tavilani
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Grant name
از محل يك درصد بودجه طرح‌هاي تحقيقاتي دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-Chancellor of Research and Technology, Hamadan 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
Research Center for Health Sciences, Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
MD, PhD, Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0090
Fax
+98 81 1838 0509
Email
poorolajal@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Urology, School of Medicine
Full name of responsible person
Dr Mohammad Ali Amirzargar
Position
MD, Assistant Professor of Urology
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
Fax
Email
dr_amirzargar@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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