The comparison of the effect of HCG and clomiphene citrate on semen parameters in men with severe Oligoasthenospermia
Design
By picking up a piece of paper that has been placed in a pack with equal numbers of 1 or 2, 90 patients will be divided into two groups of 1 or clomiphene citrate and 2 or HCG.
The trial is parallel group randomized trial without blinding. Phase 3 of clinical trial.
Settings and conduct
All the infertile men who refer to Urology clinic of Imam Reza Hospital of Kermanshah University of Medical Sciences can participate in the study.
Then according to inclusion and exclusion criteria 90 patients will be selected and randomly allocated into two groups. A base semen analysis will be obtained, then group one will be treated by 50 mg/PO/OD clomiphene citrate for 3 months and group 2 by 2500 U HCG/IM 3 times in week for 3 months. at the end of trial semen analysis will be obtained. Semen parameters between groups will be compared.
Participants/Inclusion and exclusion criteria
All the infertile men who refer to Urology clinic of Imam Reza Hospital of Kermanshah University of Medical Sciences can participate in the study.
Inclusion criteria: Severe Oligoasthenospermia with less than 5 millions sperm
Exclusion criteria: Definite etiology for Oligospermia, unwilling to participate
Intervention groups
group 1 or treatment by clomiphene citrate
and 2 or treatment by HCG
Main outcome variables
Semen volume, Sperm count, the percent of abnormal sperms and motile sperms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180307038986N1
Registration date:2018-04-24, 1397/02/04
Registration timing:registered_while_recruiting
Last update:2018-04-24, 1397/02/04
Update count:0
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Hossein Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6299
Email address
hossein.abdi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of HCG and clomiphene citrate on semen parameters in men with severe Oligoasthenospermia
Public title
HCG and clomiphene citrate and their effect on semen analysis parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Severe Oligoasthenospermia
Sperm count less than 5 million
Male infertility
Exclusion criteria:
Male infertility due to a definite etiology
Sever Oligoasthenospermia due to a definite etiology
simultaneously consumption of the drugs that can affect male fertility (Testosterone, Steroids, Cimetidine, ...)
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
A 90 pieces of paper has been placed in a pack with fifty fifty numbers of 1 or 2. By picking up a piece of paper the patients will be allocated to the group 1 or clomiphene citrate and 2 or HCG.
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah County.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-01-17, 1396/10/27
Ethics committee reference number
Ir.kums.rec.1396.571
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
Semen volume, sperm count, the percent of abnormal sperms, the percent of motile sperms
Timepoint
Before the trial, 3 months after trial start
Method of measurement
Semen analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Group one will be treated by 50 mg/PO/OD clomiphene citrate for 3 months
Category
Treatment - Drugs
2
Description
Intervention group: Group 2 will be treated by 2500 U HCG/IM 3 times in week for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology clinic Imam Reza Hospital of Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hossein Abdi
Street address
Boostan clinic of Imam Reza Hospital of Kermanshah University of Medical Sciences, Parastar Blvd., Kermanshah County
City
Kermanshah
Province
Kermanshah
Postal code
34276343
Phone
+98 83 3427 6301
Email
hossein.abdi@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hossein Abdi
Street address
Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah County
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
hossein.abdi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hossein Abdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Boostan clinic of Imam Reza Hospital of Kermanshah University of Medical Sciences, Parastar Blvd., Kermanshah County
City
Kermanshah
Province
Kermanshah
Postal code
34276343
Phone
+98 83 3427 6300
Email
hossein.abdi@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hossein Abdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Boostan clinic of Imam Reza Hospital of Kermanshah University of Medical Sciences, Parastar Blvd., Kermanshah County
City
Kermanshah
Province
Kermanshah
Postal code
34276343
Phone
+98 83 3427 6300
Email
hossein.abdi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hossein Abdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Boostan clinic of Imam Reza Hospital of Kermanshah University of Medical Sciences, Parastar Blvd., Kermanshah County
City
Kermanshah
Province
Kermanshah
Postal code
34276343
Phone
+98 83 3427 6300
Email
hossein.abdi@kums.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The gathered data and SPSS of the data and their analysis
When the data will become available and for how long
2019
To whom data/document is available
All the researchers who request to have our data and can be helpful for their studies
Under which criteria data/document could be used
Through requesting the data via calling or mailing to corresponding author
From where data/document is obtainable
Corresponding Author
What processes are involved for a request to access data/document
Evaluating the request, responding to it, if it is possible to do. It will take about 5 days.