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A comparison study between clomiphene citrate and letrozole on semen analysis in idiopathic oligospermic infertile men

Protocol summary

Summary
The main purpose:A comparison study between clomiphene citrate and letrozole on semen analysis in idiopathic oligospermic infertile men; Design study: Single-blind randomized clinical trial, treatment with medication, single-center; Study population: men; Inclusion criteria: Infertile men with sperm concentration, less than15 million per milliliter progressive motility, less than 32% total (progressive + non-progressive) motility,less than 40% , or morphologically normal forms,less than 4.0% ; Exclusion criteria for study: Infertile male with Varicocele, Abnormal FSH,LH,TSH,Testestrone and Prolactin, Abnormal liver or kidney function tests; Sample size: 80 people, two groups of 40 people; Interventions: A total of 80 infertile men (according to WHO criteria in 2010, without clinical varicocele and with normal hormonal assay) will randomly be all coated to clomiphene (clomide, Iran hormone, Tehran/Iran, 25 milligram daily ) or Letrozol (Letrofam, Iran Hormone/ Tehran/Iran, 2.5 milligram daily) for 3 months. Semen Analysis will be assessed one week before and 3 months after last medications.( in one lab by one person); Intervention time: 3 months; The outcome of the study:Sperm concentrating, Sperm motility , Sperm morphology and semen volume according to the semen analysis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041721344N2
Registration date: 2016-04-26, 1395/02/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-26, 1395/02/07
Registrant information
Name
Azam Azargoon
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 0066
Email address
a-azargoon@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Expected recruitment start date
2012-08-19, 1391/05/29
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
A comparison study between clomiphene citrate and letrozole on semen analysis in idiopathic oligospermic infertile men
Public title
clomiphene and letrozole in idiopathic oligospermic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Infertile men with sperm concentration, less than15 million per ml progressive motility, less than 32% total (progressive + non-progressive) motility,less than 40% , or morphologically normal forms,less than 4.0% ؛ exclusion criteria:Infertile male with Varicocele, Abnormal FSH and LH and TSH and Testestrone and Prolactin, Abnormal liver or kidney function tests.
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University Of Medical Scienes &amp
Street address
Semnan University of Medical Sciences, BasijBoulevard
City
Semnan
Postal code
3519899951
Approval date
2012-08-14, 1391/05/24
Ethics committee reference number
175723/95

Health conditions studied

1

Description of health condition studied
Male infertility
ICD-10 code
N40-N51
ICD-10 code description
Diseases of male genital organs

Primary outcomes

1

Description
Sperm concentration
Timepoint
one week after last medication
Method of measurement
Semen analysis

Secondary outcomes

1

Description
Sperm motility
Timepoint
one week after last medication
Method of measurement
Semen analysis

2

Description
Sperm morphology
Timepoint
one week after last medication
Method of measurement
Semen analysis

3

Description
semen volume
Timepoint
one week after last medication
Method of measurement
Semen analysis

Intervention groups

1

Description
In first group clomiphene (clomide, Iran hormone, Tehran/Iran, 25 milligram daily) will be given for 3 months.
Category
Treatment - Drugs

2

Description
In second group Letrozol (Letrofam, Iran Hormone/ Tehran/Iran, 2.5 milligram daily) will be given for 3 months. Semen Analysis will be assessed one week after last medications.( in one lab by one person).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital, Semnan
Full name of responsible person
Dr Azam Azargoon
Street address
Amiralmomenin Hospital,Imam Hossein Square, Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Full name of responsible person
Dr Mohamad Reza Asgari
Street address
Semnan University of Medical Sciences, Basij Boulevard
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 for Research and Technology, 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 Azam Azargoon
Position
Gynecologist / Associate Professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Imam Hossein Square
City
Semnan
Postal code
Phone
+98 23 3346 1433
Fax
Email
azarmona2003@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Azam Azargoon
Position
Gynecologist / Associate Professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Imam Hossein Square
City
Semnan
Postal code
Phone
+98 23 3346 1433
Fax
Email
azarmona2003@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
Samaneh Lavvaf
Position
BS of Statistics/Expert Research Center Abnormal Uterine Bleeding
Other areas of specialty/work
Street address
Amiralmomenin Hospital, mam Hossein Square, Semnan
City
Semnan
Postal code
Phone
+98 23 3346 1433
Fax
Email
sama_lavvaf@yahoo.com
Web page address

Sharing plan

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