Survey of effectiveness of autologous platelet-rich plasma and low-power laser in the treatment of male infertility
Design
Eligible men referring to infertility clinics are divided into three groups. All patients are given a consent form.Patients in the first group are injected with PRP intratesticularly and receive laser acupuncture twice a week for 4 consecutive weeks. second group, PRP is injected once, and the third group is considered as a control group without any intervention.To perform PRP, platelet-rich plasma is collected from fresh whole blood from a peripheral vein, stored in acid-citrate dextrose A (ACD-A) anticoagulant solution, and to increase platelets, autologous blood is centrifuged using a kit. and PRP equipment is processed.
The intervention is in the form of energy transfer by laser acupuncture and PRP injection on specified points perform. The semen samples taken before the start of the intervention, immediately after the end of the intervention and three months after the end of the intervention.
Settings and conduct
Shahada Tajrish Hospital and Skin and Stem Cell Research Center
Participants/Inclusion and exclusion criteria
Men under 45 years old with non-obstructive azoospermia, which pathology is confirmed from testicular tissue, and have the history of problems and genetics, drug use during the past year, the presence of varicocele in the examination or ultrasound, the presence of Sertoli cell syndrome in the testicular biopsy report, the absence of testicular descent, the history of acute epidemivaricitis, abnormal examination of the testicles, and also . They were not the risk of having a job with chemical and radioactive materials and obstructive azoospermia.
Intervention groups
1- First intervention group: PRP
2- Second intervention group: PRP and laser
3- Control group
Main outcome variables
sperm motility, concentration and morphology of semen, Sperm count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N43
Registration date:2023-05-06, 1402/02/16
Registration timing:registered_while_recruiting
Last update:2023-05-06, 1402/02/16
Update count:0
Registration date
2023-05-06, 1402/02/16
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Autologous Platelet-Rich Plasma (PRP) and laser acupuncture in the Therapy of Infertile Men with Non-Obstructive Azoospermia
Public title
Efficacy of autologous platelet-rich plasma and laser acupuncture in the treatment of non-obstructive azoospermia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 45 years
non-obstructive azoospermia with testicular pathology tissue confirmation
Exclusion criteria:
History of hormonal and genetic disorders
History of taking hormonal supplements during the last year
Presence of varicocele in examination or ultrasound
Presence of Sertoli cell-only syndrome report in testicular biopsy report
History of undescended testicles
History of acute epididymo-orchitis
Abnormal examination of testicles
History of occupational exposure to chemical and radioactive substances
Obstructive azoospermia.
Age
To 45 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, 45 patients with infertility randomly will be included in the study. For the random allocation of individuals in the study groups, the method of random allocation with block method (Block Randomization) will be used. In this method, blocks with a size of 9 (5 blocks) with a ratio of 1: 1 will be used. Random Allocation software version 2 will be used to generate random sequences. The random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified on the cards and these cards are placed inside the sealed envelopes in order. To maintain the created sequence, the numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined.
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
Organizational Committee of Ethics in Biomedical Research
Street address
Tehran - Shahid Chamran Highway-Yemen Street - Shahid Arabi Street next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-12-04, 1401/09/13
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.578
Health conditions studied
1
Description of health condition studied
azoospermia
ICD-10 code
N46.0
ICD-10 code description
Azoospermia
Primary outcomes
1
Description
Sperm count
Timepoint
The first sample is taken before the start of the intervention, the second sample is taken after the last secion of the intervention, and the third sample is taken three months after the last intervention.
Method of measurement
sperm analysis
2
Description
Sperm morphology
Timepoint
The first sample is taken before the start of the intervention, the second sample is taken after the last secion of the intervention, and the third sample is taken three months after the last intervention.
Method of measurement
sperm analysis
3
Description
Sperm motility
Timepoint
The first sample is taken before the start of the intervention, the second sample is taken after the last secion of the intervention, and the third sample is taken three months after the last intervention.
Method of measurement
sperm analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: PRP is injected into the testicle, and they receive laser acupuncture twice a week for 4 consecutive weeks.
Category
Treatment - Devices
2
Description
Intervention group: PRP is injected into the testice
Category
Treatment - Devices
3
Description
Control group: without treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohaha- Tajrish Hospital
Full name of responsible person
Mohammadhasan Mazloomfard
Street address
Shardari st, Tajrish sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8001
Email
laser.cntr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin zarghi
Street address
Yaman st, Danshjoo Blvd, Velenjak st
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Laser Application Research Center in Medical Sciences
Full name of responsible person
Mohammad Reza Razzaghi
Position
Professor of Urology, Shahid Beheshti University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohada Tajrish Hospital, Shahrdary st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8021
Email
laser.cntr@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Reza Razzaghi
Position
Professor of Shahid Beheshti University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohada Tajrish Hospital, Shahrdary st, Tajrish sq, Tehran
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8021
Email
laser.cntr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Razaghi
Position
Professor of Shahid Beheshti University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohada-e-Tajrish Medical center, Shahrdari st,Tajrish Sq
City
تهران
Province
Tehran
Postal code
1989934148
Phone
0098 212249221
Email
laser.cntr@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