Investigation of plasma rich growth factor in treatment of patients with azoospermia
Design
Clinical trial without control group, community based, not blinded, Non-randomised controlled study
Settings and conduct
This study will be done in najmeyeh infertility center and kerman medical university. After selection of patients by clinician, their blood will be taken and PRGF provided. Then PRGF for every 2 weeks were injected for 3 times. and the patients will be follow up for 3 and 6 months after injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients with non obstructive azoospermia
2- Signs of maturation arrest in testis biopsy
3- Patients aged between 20-65 years
Exclusion criteria:
1- patients with obstructive azoospermia
2- Patients with previous testis surgery
3- Males with genital tract infection or anatomical abnormalities
4- Patients with severe medical problems
5- chromosomal abnormalities
6- presence of Sertoli cell only syndrome in testis biopsy
Intervention groups
Plasma rich in growth factors prepared from the patient's blood is injected three times at intervals of every 2 weeks to the patient's testicles and after 3 months and 6 months from the last injection, the effect of this extract on the spermatogenesis of the patients will be measured.
Main outcome variables
Investigation or increase in sperms in spermatogram
Investigation in improvement in spermatogenesis in biopsy
Increased in possibility of fertility
General information
Reason for update
Acronym
TAP
IRCT registration information
IRCT registration number:IRCT20140911019125N2
Registration date:2019-02-21, 1397/12/02
Registration timing:registered_while_recruiting
Last update:2019-02-21, 1397/12/02
Update count:0
Registration date
2019-02-21, 1397/12/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32 24618
Email address
afarsinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigation of the effect of Plasma Rich Growth Factor (PRGF) in treatment of patient with azoospermia
Public title
Treatment of azoospermia with plasma rich growth factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with non-obstructive azoospermia
Signs of maturation arrest in testis biopsy
patients aged between 20-65 years
Exclusion criteria:
Patients with obstructive azoospermia
Patients with pervious testis surgery
Males with genital tract infection or anatomical abnormalities
Patients with severe medical problems
Chromosomal abnormality
Present of Sertoli cell only syndrome in biopsy of testis
Age
From 20 years old to 65 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
27
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 kerman university of medical science
Street address
Haft Bagh Blvd, Kerman university of medical science
City
kerman
Province
Kerman
Postal code
7616911333
Approval date
2018-12-10, 1397/09/19
Ethics committee reference number
IR.KMU.REC.1397.360
Health conditions studied
1
Description of health condition studied
Infertility treatment
ICD-10 code
N50.8
ICD-10 code description
Other specified disorders of male genital organs
Primary outcomes
1
Description
Investigation and increasing in sperms in spermogram
Timepoint
Before intervention and 3, 6 months after intervention
Method of measurement
Microscopic measurment
2
Description
Investigation and improvement in spermatogenesis in biopsy
Timepoint
Before intervention and 3 , 6 months after intervention
Method of measurement
Microscopic measurment
Secondary outcomes
empty
Intervention groups
1
Description
In this study, own of the patient's blood derivatives (Platelet rich growth factors/PRGF) is used. This product is injected 3 times at intervals of 2 weeks to patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Najmiyeh infertility center
Full name of responsible person
Mohsen Karvar
Street address
Haft Bagh Blvd, Najmiyeh infertility Center
City
Kerman
Province
Kerman
Postal code
7613657761
Phone
+98 34 3323 3410
Email
Mohsenkarvar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Haft bagh Blvd. kerman university of medical science
City
kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft bagh Blvd, kerman university of medical science
City
kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft Bagh Blvd, kerman university of medical science
City
kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft-Bagh Blvd, kerman university of medical science
City
kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no additional data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
In our study non of the personal data of patients will be shared. Only data that are related to outcomes of intervention will be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
The data will be available for people working in academic institutions and clinicians.
Under which criteria data/document could be used
Applicants are only allowed to use received data in clinical and they are not allowed to published them.
From where data/document is obtainable
1- Phone: 034-31325374
2- e-mail: afarsinejad@kmu.ac.ir
3- Fax: 034-31325375
4- address: Haft bagh Blvd, Kerman university of medical science
Dr. Alireza Farsinejad
What processes are involved for a request to access data/document
Applicant can receive information after contact and send e-mail up to 10 days.