Protocol summary
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Study aim
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Determining the safety and effect of PRP on the process of spermatogenesis in azoospermic patients
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Design
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Clinical trial without control group, before and after, without blinding, randomized, on 20 patients
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Settings and conduct
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This study will be conducted only on 20 NOA patients referred to Royan Institute with negative mTESE history. There is no control group and blinding will not be done. After receiving the permission of the ethics committee for the research, the research samples will be selected based on the study entry criteria. After obtaining informed consent to participate in the research, they will be subjected to intratesticular PRP injection.
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Participants/Inclusion and exclusion criteria
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Men over 18 years with a history of non-obstructive azoospermia and at least one failed mTESE will be included in the study.
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Intervention groups
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After receiving the permission of the ethics committee in the research, the research samples after obtaining informed consent to participate in the research, they will be subjected to intratesticular PRP injection.
To prepare PRP, the α-PRP - Celltech Biogenesis, Iran will be used.
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Main outcome variables
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Comparing the effect of PRP on LH hormone levels after PRP injection
Comparing the effect of PRP on FSH and testosterone levels after PRP injection
Comparison of the effect of PRP on individual Semen Analysis after PRP injection
Comparison of the effect of PRP on the outcome of mTESE, after PRP injection
Determination of fertilization rate, clinical pregnancy (hCG positive), stable implantation (more than 8 weeks) if sperm is found
General information
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Reason for update
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Dear IRCT Administrator,
We need to update our trial record because recruitment and the trial have now ended, with final dates recorded on 2025-10-13, 1404/07/21 for recruitment and 2026-02-19, 1404/11/30 for the trial, and because the originally specified kit type was replaced in this study (from alpha PPR kit to BD) to maintain assay consistency; the previous kit data should be superseded for accurate documentation.
Thank you for your support.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221128056644N1
Registration date:
2023-06-03, 1402/03/13
Registration timing:
prospective
Last update:
2026-05-11, 1405/02/21
Update count:
3
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Registration date
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2023-06-03, 1402/03/13
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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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2024-02-20, 1402/12/01
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Expected recruitment end date
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2025-03-21, 1404/01/01
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Actual recruitment start date
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2024-06-16, 1403/03/27
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Actual recruitment end date
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2025-10-13, 1404/07/21
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Trial completion date
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2026-02-19, 1404/11/30
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Scientific title
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The Efficacy of Autologous Testicular Platelet Rich Plasma (PRP) for Patients with a History of Microdissection Testicular Sperm Extraction (mTESE) Failure: Clinical Trial
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Public title
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The Efficacy of testicular PRP for patients with history of mTESE failure
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Men over 18 years
Men with a history of non-obstructive azoospermia and at least one failed mTESE
Spouses without any disease related to female infertility
Exclusion criteria:
Obstructive azoospermia patients
Patients with systemic medical problems
Patients with chromosomal disorders
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Age
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From 18 years old
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Gender
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Male
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Phase
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1
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Groups that have been masked
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No information
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Sample size
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Target sample size:
20
Actual sample size reached:
15
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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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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2023-05-09, 1402/02/19
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Ethics committee reference number
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IR.ACECR.ROYAN.REC.1402.016
Health conditions studied
1
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Description of health condition studied
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Non-obstructive azoospermia
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ICD-10 code
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N46.029
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ICD-10 code description
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Azoospermia due to other extratesticular causes
Primary outcomes
1
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Description
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Spermatogenesis in non-obstructive azoospermia patients
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Timepoint
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Semen Analysis before PRP injection and ≥3 months after PRP injection.
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Method of measurement
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Semen Analysis and Microdissection Testicular Sperm Extraction
Secondary outcomes
1
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Description
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Determination of fertilization rate
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Timepoint
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After PRP injection
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Method of measurement
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Microscopic observations
Intervention groups
1
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Description
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Intervention group: Patients with non-obstructive azoospermia have at least one mTESE failure history. After receiving the permission of the ethics committee in the research, the research samples are selected based on the criteria for entering the study. After obtaining informed consent to participate in the research, they will be subjected to intratesticular injection of PRP. The PRP kit ( BD Vacutainer® Specialty Tubes, SKU:364606) will be used to prepare PRP. The duration of PRP preparation will be less than 45 minutes. Prepared PRP is injected into the spermatic cord or the interstitial space using a 5 mL syringe. In the third month after testicular PRP, gonadotropin stimulation in the patient's wife begins on days 2 to 4 of the menstrual cycle. Sperm extraction with the mTESE method will be performed at the same time as the egg retrieval day to use fresh sperm cells. In the first stage, 3 months after PRP injection into the testicles, sperm analysis will be checked in patients. The second stage will be 6 months after the injection. According to the obtained results, the sperm is injected into the cytoplasm of the egg by assisted reproductive techniques (ICSI) and fertilization takes place.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Royan Lotus Charity Found
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Grant code / Reference number
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NA
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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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Royan Institute
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Proportion provided by this source
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75
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Public or private sector
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Private
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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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Other
2
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Sponsor
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Grant name
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Royan Institute for Reproductive Biomedicine Fundation
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Grant code / Reference number
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NA
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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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Royan Institute
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Proportion provided by this source
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25
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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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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not 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