Protocol summary
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Study aim
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Determining and comparing the effect of platelet-rich plasma by testicular injection on the number, motility, and morphology of sperm in infertile men with non-obstructive ezoospermia candidates for TESE before and after the intervention in two groups
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Design
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Blocked randomized clinical trial with control group; a blind man; Block randomized; 68 patients.
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Settings and conduct
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The research environment is the infertility clinic of Fatemieh Hospital in Hamedan and the time of the research is in 2022-2023. The research population includes all infertile men who are candidates for infertility treatment with non-obstructive azoospermia referring to the infertility clinic of Fatemieh Hospital. The research sample is any infertile man suffering from non-obstructive azoospermia, referring to the infertility clinic of Fatemieh Hospital in Hamadan. For the intervention group, PRP 2CC is injected into the testicle tissue by the same urologist under local anesthesia, and analyzed after three months. Sperm is checked. There is no intervention for the control group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age range 20-45 years; lack of sperm in 2 sperm analysis samples;
Exclusion criteria: receiving other treatments such as hormone therapy and suffering from underlying diseases (such as diabetes, kidney disease, liver disease, drug and alcohol use, and types of cancer and receiving chemotherapy treatments)
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Intervention groups
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For the intervention group, PRP 2CC is injected into the testicle tissue by the same urologist under local anesthesia, and sperm analysis is checked after three months. There is no intervention for the control group.
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Main outcome variables
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Azoospermia
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220317054318N3
Registration date:
2023-02-09, 1401/11/20
Registration timing:
prospective
Last update:
2026-07-22, 1405/04/31
Update count:
1
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Registration date
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2023-02-09, 1401/11/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-02-20, 1401/12/01
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Expected recruitment end date
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2023-10-23, 1402/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluate the effect of platelet-rich plasma(PRP) by testicular injection on spermogram parameters of infertile men with Non-obstructive Azoospermia candidate for TESE
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Public title
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The effect of PRP in the treatment of ezoospermia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age range 20-45 years
Having no sperm in 2 sperm analysis samples
Exclusion criteria:
Receive other treatments
Suffering from underlying diseases (such as diabetes, kidney disease, liver disease, drug and alcohol use) and types of cancer and receiving chemotherapy treatments
Addiction and use of cigarettes
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Age
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From 20 years old to 45 years old
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Gender
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Male
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Phase
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0
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Groups that have been masked
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The first stage of selection of those eligible to enter the study is done in an easy and accessible way, but after selecting those eligible to enter the study, the participants are randomly divided into two intervention and control groups. Randomization is done by block method and considering that we have two groups, blocks of 4 are used. Blocked randomization is for the purpose of making sure that exactly the same number of participants enter the 2 control intervention groups in consecutive but equal time intervals. For this purpose, random block is used. 18 sheets of paper are prepared and the letter A is written on 9 sheets and the letter B is written on the other 9 sheets. and upon the application of each eligible person to enter the study, one of the sheets is randomly drawn and assigned to the intervention and control group based on whether it is group A or B, and the drawn sheets until all 18 sheets If it has not been pulled out, it will not be returned to the drawer, and after randomly pulling out all 18 sheets, all the sheets are returned to the drawer and the above procedure is continued on the next 18 patients up to 4 times, i.e. completing the sample volume to 68
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants are blinded to the treatment method during the study.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-01-28, 1401/11/08
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Ethics committee reference number
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IR.UMSHA.REC.1401.941
Health conditions studied
1
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Description of health condition studied
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Azoospermia
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ICD-10 code
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N46
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ICD-10 code description
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Male infertility
Primary outcomes
1
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Description
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Number, movement and shape of sperm
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Timepoint
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3 month
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Method of measurement
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Sperm analysis
2
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Description
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FSH, LH , prolactin and Testosterone tests
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Timepoint
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3 month
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Method of measurement
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Chemiluminescent immunoassays
Intervention groups
1
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Description
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Intervention group:34 patients who were once injected with 2 cc of platelet-rich plasma inside the testicular tissue by a regular urologist.
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Category
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Treatment - Surgery
2
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Description
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Control group: 34 patients for whom placebo is used.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available