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Evaluate the effect of platelet-rich plasma(PRP) by testicular injection on spermogram parameters of infertile men with sever oligoasthenoteratozoospermia (OAT)

Protocol summary

Study aim
Determination and comparison of DNA breakage index in infertile men before and after intervention in two groups Determination and comparison of sperm count and motility in infertile men before and after intervention in two groups
Design
Clinical trial with a control group, single-blind, randomized, 88 patients. The rand function of Excel software was used for randomization.
Settings and conduct
A Clinical trial with a control group, single-blind, randomized.in the infertility clinic of Fatemieh Hospital in Hamedan,in 2023. The patients with Inclusion criteria divided into control and intervention groups with randomized block method, The patients were blinded
Participants/Inclusion and exclusion criteria
Entry criteria: age range 20-45 years, sperm count <20 million, Movement < 5*106ml, progressive movement < 20%, normal morphology < 10% Non-entry criteria: receiving other treatments and suffering from underlying diseases (such as diabetes, kidney disease, liver disease, drug and alcohol use) and types of cancer and receiving chemotherapy treatments
Intervention groups
For the intervention group, 2 cc of platelet-rich plasma is injected into the testicles by the same urologist with local anesthesia, and after three months, sperm analysis and DNA breakage index are checked, and the control group does not receive any intervention.
Main outcome variables
Sperm analysis, sperm DNA fragmentation index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220317054318N2
Registration date: 2023-02-08, 1401/11/19
Registration timing: prospective

Last update: 2023-02-08, 1401/11/19
Update count: 0
Registration date
2023-02-08, 1401/11/19
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
2023-02-20, 1401/12/01
Expected recruitment end date
2023-10-23, 1402/08/01
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 spermogram parameters of infertile men with sever oligoasthenoteratozoospermia (OAT)
Public title
Investigating the effect of PRP in oligospermia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20-45 years. sperm count less than 20 million, Movement less than 106 x 5 ml, progressive movement < 20%, normal morphology < 10%
Exclusion criteria:
Receiving other treatments for oligospermia such as hormone therapy Suffering from underlying diseases (such as diabetes, kidney disease, liver disease, drug and alcohol addiction) and types of cancer and receiving chemotherapy treatments
Age
From 20 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, the selection of those eligible to enter the study is done in an easy and accessible way, but after the selection of those eligible to enter the study, the participants are randomly divided into two intervention and control groups. Randomization is done by block method. In this way, we prepare 18 sheets of paper and write the letter A on 9 sheets and the letter B on the other 9 sheets. In the study, one of the sheets is taken out randomly and according to whether it is group A or B, it is assigned to the intervention and control group, and the sheets drawn out do not return to the drawer until all 18 sheets have been drawn, and after completion 18 sheets are returned to the drawer and the above operation is repeated until the number of samples is complete
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the people participating in the study are kept blind and do not obey the treatment process
Placebo
Not used
Assignment
Parallel
Other design features
The study has two intervention groups and a control group, the intervention group receives platelet-rich plasma and the control group receives placebo.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Pasdaran street
City
Hamedan
Province
Hamadan
Postal code
6517789971
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.UMSHA.REC.1401.941

Health conditions studied

1

Description of health condition studied
Oligostenoteratozoospermia
ICD-10 code
N46
ICD-10 code description
Male infertility

Primary outcomes

1

Description
Sperm count and motility in men
Timepoint
3 months after intratesticular platelet rich plasma injection
Method of measurement
Sperm analysis, DNA fragmentation index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:including 44 patients who were injected with 2cc of platelet-rich plasma by the urologist inside their testicles
Category
Treatment - Surgery

2

Description
Control group:44 patients who do not undergo any intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemiyah Hospital
Full name of responsible person
SHamim Pilehvary
Street address
Pasdaran Street
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3834 0266
Email
sh.pilevar@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza SHokohi
Street address
Pasdaran Street
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3838 0749
Email
Sh.pilevar@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 Pilehvary
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Street
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3834 0266
Email
Sh.pilevar@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
SHamim Pilehvary
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Street
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3834 0266
Email
Sh.pilevar@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
SHamim Pilehvary
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Street
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3834 0266
Email
faezehbehnam7@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
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