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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Protocol summary
Determining the effect of PRP on the process of spermatogenesis in azoospermic patients
Determining the safety and effect of PRP on the process of spermatogenesis in azoospermic patients
Determining the safety and effect of PRP on the process of spermatogenesis in azoospermic patients
تعیین اثر PRP بر روند اسپرماتوژنز در بیماران آزواسپرمی
تعیین بی خطری و اثر PRP بر روند اسپرماتوژنز در بیماران آزواسپرمی
تعیین بی خطری و اثر PRP بر روند اسپرماتوژنز در بیماران آزواسپرمی
This study will be conducted only on a group of 20 NOA patients referred to Royan Institute with negative mTESE history.
There is no control group and blinding will not be done. Also, in the first phase, the study will be conducted as a pilot, and after the data analysis, if the clinical analysis is significant - taking into account the primary goal of observing the treatment in these patients - the next phase of the study will be conducted.
After receiving the permission of the ethics committee in the research, the research samples will be selected based on the study entry criteria and after obtaining informed consent to participate in the research, they will be subjected to intratesticular PRP injection.
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.
This study will be conducted only on a group of 20 NOA patients referred to Royan Institute with negative mTESE history. There is no control group and blinding will not be done. Also, in the first phase, the study will be conducted as a pilot, and after the data analysis, if the clinical analysis is significant - taking into account the primary goal of observing the treatment in these patients - the next phase of the study will be conducted. After receiving the permission of the ethics committee infor the research, the research samples will be selected based on the study entry criteria and after. After obtaining informed consent to participate in the research, they will be subjected to intratesticular PRP injection.
این مطالعه تنها روی یک گروه 20 نفری از بیماران NOA مراجعه کننده به پژوهشگاه رویان با سابقه mTESE منفی انجام خواهد شد.
گروه کنترل ندارد و در آن کور سازی انجام نخواهد شد. همچنین در مرحله اول، مطالعه به صورت پایلوت صورت خواهد گرفت و پس از آنالیز داده ها، در صورت معنی دار بودن بررسی های بالینی- با احتساب هدف اولیه مشاهده درمان در این بیماران- فاز بعدی مطالعه انجام خواهد شد.
پس از دریافت مجوز کمیته اخلاق در پژوهش، نمونههای پژوهش بر اساس معیارهای ورود به مطالعه گزینش شده و پس از اخذ رضایت آگاهانه جهت شرکت در پژوهش، تحت اقدامات جهت تزریق داخل بیضه ای PRP قرار خواهند گرفت.
این مطالعه تنها روی یک گروه 20 نفری از بیماران NOA مراجعه کننده به پژوهشگاه رویان با سابقه mTESE منفی انجام خواهد شد. گروه کنترل ندارد و در آن کور سازی انجام نخواهد شد. پس از دریافت مجوز کمیته اخلاق در پژوهش، نمونههای پژوهش بر اساس معیارهای ورود به مطالعه گزینش شده و پس از اخذ رضایت آگاهانه جهت شرکت در پژوهش، تحت اقدامات جهت تزریق داخل بیضه ای PRP قرار خواهند گرفت.
این مطالعه تنها روی یک گروه 20 نفری از بیماران NOA مراجعه کننده به پژوهشگاه رویان با سابقه mTESE منفی انجام خواهد شد. گروه کنترل ندارد و در آن کور سازی انجام نخواهد شد. همچنین در مرحله اول، مطالعه به صورت پایلوت صورت خواهد گرفت و پس از آنالیز داده ها، در صورت معنی دار بودن بررسی های بالینی- با احتساب هدف اولیه مشاهده درمان در این بیماران- فاز بعدی مطالعه انجام خواهد شد. پس از دریافت مجوز کمیته اخلاق در پژوهش، نمونههای پژوهش بر اساس معیارهای ورود به مطالعه گزینش شده و پس از اخذ رضایت آگاهانه جهت شرکت در پژوهش، تحت اقدامات جهت تزریق داخل بیضه ای PRP قرار خواهند گرفت.
General information
N/A
1
na1
To address some of the inconsistencies in the input date.
Change the study phase from NA to 1.
Add "Safety" as the study's aim (the research work procedures will not change).
Remove the word "pilot" from the study plan.
Add the word "autologous" to the title of the study.
To address someChange the study phase from NA to 1. Add "Safety" as the study's aim (the research work procedures will not change). Remove the word "pilot" from the study plan. Add the word "autologous" to the title of the inconsistencies in the input datestudy.
یک عدم هماهنگی در تعداد بیمارانی که در این طرح قرار است وارد مطالعه شوند وجود دارد. این به روز رسانی به منظور رفع این ناهماهنگی ها است.
فاز مطالعه از NA به 1 تغییر یابد.
بررسی Safety به اهداف طرح اضافه شود (مراحل انجام کار تغییری نمی یابد).
واژه پایلوت از طرح حذف شود.
واژه اتولوگ به عنوان طرح اضافه شود.
یک عدم هماهنگی در تعداد بیمارانی که در اینفاز مطالعه از NA به 1 تغییر یابد. بررسی Safety به اهداف طرح قرار است وارد مطالعه شوند وجود دارداضافه شود (مراحل انجام کار تغییری نمی یابد). اینواژه پایلوت از طرح حذف شود. واژه اتولوگ به روز رسانی به منظور رفع این ناهماهنگی ها استعنوان طرح اضافه شود.
The Efficacy of testicular Platelet Rich Plasma (PRP) for patients with history of Microdissection Testicular Sperm Extraction (mTESE) failure: Clinical Trial
The Efficacy of Autologous Testicular Platelet Rich Plasma (PRP) for Patients with a History of Microdissection Testicular Sperm Extraction (mTESE) Failure: Clinical Trial
The Efficacy of testicularAutologous Testicular Platelet Rich Plasma (PRP) for patientsPatients with historya History of Microdissection Testicular Sperm Extraction (mTESE) failureFailure: Clinical Trial
اثربخشی تزریق درون بیضه ای پلاسمای غنی از پلاکت (PRP) در مردان با سابقه استخراج اسپرم از بیضه ناموفق: کارآزمایی بالینی
اثربخشی تزریق درون بیضه ای پلاسمای غنی از پلاکت (PRP) اتولوگ در مردان با سابقه استخراج اسپرم از بیضه ناموفق: کارآزمایی بالینی
اثربخشی تزریق درون بیضه ای پلاسمای غنی از پلاکت (PRP) اتولوگ در مردان با سابقه استخراج اسپرم از بیضه ناموفق: کارآزمایی بالینی
Protocol summary
Study aim
Determining the safety and effect of PRP on the process of spermatogenesis in azoospermic patients
Design
Clinical trial without control group, before and after, without blinding, randomized, on 20 patients
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Men over 18 years with a history of non-obstructive azoospermia and at least one failed mTESE will be included in the study.
Intervention groups
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.
Main outcome variables
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
Reason for update
Change the study phase from NA to 1.
Add "Safety" as the study's aim (the research work procedures will not change).
Remove the word "pilot" from the study plan.
Add the word "autologous" to the title of the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20221128056644N1
Registration date:2023-06-03, 1402/03/13
Registration timing:prospective
Last update:2024-02-19, 1402/11/30
Update count:3
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Marjan Sabbaghian
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2730
Email address
Marjan.sabbaghian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Autologous Testicular Platelet Rich Plasma (PRP) for Patients with a History of Microdissection Testicular Sperm Extraction (mTESE) Failure: Clinical Trial
Public title
The Efficacy of testicular PRP for patients with history of mTESE failure
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Male
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Royan Institute- Academic Center for Education, Culture and Research
Spermatogenesis in non-obstructive azoospermia patients
Timepoint
Semen Analysis before PRP injection and 3 months after PRP injection. Also, if sperm is not observed, 6 months after PRP injection
Method of measurement
Semen Analysis and Microdissection Testicular Sperm Extraction
Secondary outcomes
1
Description
Determination of fertilization rate
Timepoint
After PRP injection
Method of measurement
Microscopic observations
Intervention groups
1
Description
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 ( α-PRP - Celltech Biogenesis, Iran) 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.