Evaluate the effect of platelet-rich plasma(PRP) by testicular injection on sperm DNA fragmentation index of infertile men with sever oligoasthenoteratozoospermia (OAT)
Determining the effect of platelet-rich plasma(PRP) by testicular injection on sperm DNA fragmentation index of infertile men with sever oligoasthenoteratozoospermia (OAT)
Design
The clinical trial work has two control groups and a single-blind intervention, which is randomly allocated in a block and includes 160 samples, which are divided into two groups of 80 people.
Settings and conduct
The current study is a randomized clinical trial that is conducted in the infertility clinic of Fatemiyeh Hospital in Hamadan in 1402 on infertile men who are candidates for infertility treatment with oligoasthenoteratozoospermia. The subjects included two groups that were randomly assigned in a block manner, the control group received routine treatment, and the intervention group received platelet-rich plasma injection in the testicles. In this study, the participants are unaware of the allocation group and are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 20-45 years, sperm count< 20 million, Movement < 106 x 5 ml, progressive movement < 20%, normal morphology < 10%.
Not Inclusion criteria: receiving other treatments such as hormone therapy,
suffering from underlying diseases (such as diabetes, kidney disease, liver disease and alcohol addiction) and types of cancer and receiving chemotherapy treatments, signs of infection in semen, varicocele
Intervention groups
The intervention group includes study subjects who receive intratesticular injection of platelet-rich plasma.
The control group includes people who only receive routine treatments.
Main outcome variables
Sperm DNA fragmentation index
General information
Reason for update
Acronym
PRP
IRCT registration information
IRCT registration number:IRCT20220317054318N4
Registration date:2023-07-05, 1402/04/14
Registration timing:prospective
Last update:2023-07-05, 1402/04/14
Update count:0
Registration date
2023-07-05, 1402/04/14
Registrant information
Name
Shamim Pilevari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 7012
Email address
sh.pilevar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effect of platelet-rich plasma(PRP) by testicular injection on sperm DNA fragmentation index of infertile men with sever oligoasthenoteratozoospermia (OAT)
Public title
The effect of prp on oligospermia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20-45 years
Sperm count <20 million
Movement less than 106 x 5 ml, progressive movement < 20%, normal morphology < 10%
Not receiving other treatments such as hormone therapy
Not suffering from underlying diseases (such as diabetes, kidney disease, liver disease, drug and alcohol addiction) and types of cancer and receiving chemotherapy treatments
Absence of signs of infection in semen
Untreated varicocele
Exclusion criteria:
Unwillingness to continue participating in the study
Age
From 25 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by block method. We prepare 18 sheets of paper and write A on 9 sheets and B on other 9 sheets and put them in the drawer of the table and then each person with Inclusion criteria , one of the sheets will be given to the person randomly. Allocated and assigned to the intervention and control groups based on the letter A or B.
Blinding (investigator's opinion)
Single blinded
Blinding description
People participating in the study are unaware of the assigned group
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Fatemieh Hospital, Pasdaran St.
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.UMSHA.REC.1402.227
Health conditions studied
1
Description of health condition studied
Oligostenoteratozoospermia
ICD-10 code
N46.1
ICD-10 code description
Oligospermia
Primary outcomes
1
Description
Sperm DNA fragmentation index
Timepoint
Before the start of the intervention and after 3 months from the time of PRP injection
Method of measurement
Sperm DNA breakage index test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes sample subjects receiving platelet-rich plasma via intratesticular injection
Category
Treatment - Other
2
Description
Control group: Sample subjects receiving routine treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Shamim pilehvari
Street address
Pasdaran street
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3131 4058
Email
Sh.pilehvari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza shokohi
Street address
Shahid Fahmede Boulevard
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shamim pilehvari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Street
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3131 4058
Email
Sh.pilehvari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shamim pilehvari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Street
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3131 4058
Email
sh.pilehvari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shamim pilehvari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Street
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3131 4058
Email
sh.pilehvari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available