Frequency of fertility in unexplained male infertility referred to Urology clinic of Rafsanjan University of medical sciences after Human Menopausal Gonadotrophin (HMG) therapy
Determination of the frequency of fertility in unexplained infertile men following treatment with gonadotropin
Design
This clinical trial has a group of infertile men referred to the Urology Clinic will be select and enrolled to study by convenience method after informed consent.
Settings and conduct
Unexplained Infertile men referring to the Urology Clinic of the Rafsanjan University of Medical Sciences from the beginning of February 2019, will be enrolled in 30 individuals by convenience method after informed consent and HMG will be prescribed to them.
Participants/Inclusion and exclusion criteria
Unexplained Infertile men
Age 25-40 years
Without infertility in wife
Intervention groups
Intervention group: In this study, HMG is administered as an injectable intramuscular injection of 8 units per 75,000 units for a period of one month (2 injections per week).
Main outcome variables
Fertility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150317021497N5
Registration date:2019-02-24, 1397/12/05
Registration timing:registered_while_recruiting
Last update:2019-02-24, 1397/12/05
Update count:0
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
Mohammadreza Mokhtaree
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34260081
Email address
mrmokhtaree@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Frequency of fertility in unexplained male infertility referred to Urology clinic of Rafsanjan University of medical sciences after Human Menopausal Gonadotrophin (HMG) therapy
Public title
Effect of Human Menopausal Gonadotrophin (HMG) therapy on fertility of infertile males
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
unexplained infertility
2 years since marriage
Age 25-40 years
Men
Exclusion criteria:
Wife Infertility
Age
From 25 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Approval date
2018-03-01, 1396/12/10
Ethics committee reference number
IR.RUMS.REC.1396.125
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
frequency of fertility
Timepoint
3 months after beginning drug use
Method of measurement
Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 2 ampule of HMG (75000 unit) to 8 dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
urology Clinic, Rafsanjan University of medical sciences
Full name of responsible person
Alireza Nazari
Street address
Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
mrmokhtaree@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Rafsanjan University of medical sceinces ,Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0039
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Nazari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
mrmokhtaree@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Nazari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
mrmokhtaree@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Mokhtaree
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
mrmokhtaree@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after being unrecognizable.
When the data will become available and for how long
6 months after the end of the training
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
By providing a valid identification card and a letter of introduction
From where data/document is obtainable
Mohammadreza Mokhtaree, mrmokhtaree@yahoo.com
What processes are involved for a request to access data/document