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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General information
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2024-06-16, 1403/03/27
2024-06-16 00:00:00
empty
2025-10-13, 1404/07/21
2025-10-13 00:00:00
empty
2026-02-19, 1404/11/30
2026-02-19 00:00:00
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.
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was replaced in this study (from alpha PPR kit to BD) to maintain assay consistency; the previous kit data should be superseded for accurate documentation.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.
ChangeDear 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 phase (from NAalpha PPR kit to 1. Add "Safety" asBD) to maintain assay consistency; the study's aim (the research work procedures will not change)previous kit data should be superseded for accurate documentation. Remove the word "pilot" from the study planThank you for your support. Add the word "autologous" to the title of the study.
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.
مدیر محترم درگاه کارآزمایی بالینی ایران (IRCT)،
به روزرسانی پرونده کارآزمایی ما ضروری است زیرا مرحلهٔ ثبتنام و خود کارآزمایی به ترتیب در تاریخهای ۲۰۲۵-۱۰-۱۳ (۱۴۰۴/۰۷/۲۱) برای پایان ثبتنام و ۲۰۲۶-۰۲-۱۹ (۱۴۰۴/۱۱/۳۰) برای پایان کارآزمایی خاتمه یافتهاند. همچنین به این دلیل که نوع کیت مشخصشده در ابتدای مطالعه با کیت دیگری جایگزین شده است (از کیت آلفا PPR به کیت BD) بنابراین دادههای پیشین مربوط به کیت باید برای مستندسازی دقیق کنار گذاشته شوند.
با سپاس از همکاری شما.
فازمدیر محترم درگاه کارآزمایی بالینی ایران (IRCT)، به روزرسانی پرونده کارآزمایی ما ضروری است زیرا مرحلهٔ ثبتنام و خود کارآزمایی به ترتیب در تاریخهای ۲۰۲۵-۱۰-۱۳ (۱۴۰۴/۰۷/۲۱) برای پایان ثبتنام و ۲۰۲۶-۰۲-۱۹ (۱۴۰۴/۱۱/۳۰) برای پایان کارآزمایی خاتمه یافتهاند. همچنین به این دلیل که نوع کیت مشخصشده در ابتدای مطالعه با کیت دیگری جایگزین شده است (از NAکیت آلفا PPR به 1 تغییر یابد. بررسی Safetyکیت BD) بنابراین دادههای پیشین مربوط به اهداف طرح اضافه شود (مراحل انجام کار تغییری نمی یابد)کیت باید برای مستندسازی دقیق کنار گذاشته شوند. واژه پایلوتبا سپاس از طرح حذف شودهمکاری شما. واژه اتولوگ به عنوان طرح اضافه شود.
Primary outcomes
#1
Semen Analysis before PRP injection and 3 months after PRP injection. Also, if sperm is not observed, 6 months after PRP injection
Semen Analysis before PRP injection and ≥3 months after PRP injection.
Semen Analysis before PRP injection and ≥3 months after PRP injection. Also, if sperm is not observed, 6 months after PRP injection
بررسی آنالیز اسپرم قبل از تزریق PRP و 3 ماه بعد از تزریق PRP. همچنین در صورت مشاده نشدن اسپرم، 6 ماه پس از تزریق PRP
بررسی آنالیز اسپرم قبل از تزریق PRP و ≥3 ماه بعد از تزریق PRP.
بررسی آنالیز اسپرم قبل از تزریق PRP و ≥3 ماه بعد از تزریق PRP. همچنین در صورت مشاده نشدن اسپرم، 6 ماه پس از تزریق PRP
Intervention groups
#1
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.
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.
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 BiogenesisBD Vacutainer® Specialty Tubes, IranSKU: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 mlmL 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.
گروه مداخله: بیماران با آزواسپرمی غیر انسدادی با سابقه حداقل یک شکست در mTESE.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.جهت تهیه PRP، از کیت PRP (α-PRP - Celltech Biogenesis, Iran) استفاده خواهد شد. مدت زمان تهیه PRP کمتر از 45 دقیقه خواهد بود.PRP تهیه شده، با استفاده از سرنگ 5 ml به داخل لوله اسپرم ساز یا به فضای بینابینی تزریق میشود. در ماه سوم پس از عمل PRP بیضه، تحریک گنادوتروپین در همسر بیمار در روزهای 2 تا 4 سیکل قاعدگی آغاز میشود. استخراج اسپرم با روش mTESE همزمان با روز بازیابی تخمک به منظور استفاده از سلول های اسپرم تازه انجام خواهد شد. در مرحله اول، 3 ماه پس از تزریق PRP به بیضه، آنالیز اسپرم در بیماران بررسی خواهد شد. مرحله دوم 6 ماه پس از تزریق خواهد بود. با توجه به نتایج به دست آمده، اسپرم توسط روشهای کمک باروری( ICSI) به سیتوپلاسم تخمک تزریق میشود و لقاح صورت میگیرد.
گروه مداخله: بیماران با آزواسپرمی غیر انسدادی با سابقه حداقل یک شکست در mTESE.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.جهت تهیه PRP، از کیت PRP (BD Vacutainer® Specialty Tubes, SKU:364606) استفاده خواهد شد. مدت زمان تهیه PRP کمتر از 45 دقیقه خواهد بود.PRP تهیه شده، با استفاده از سرنگ 5mL به داخل لوله اسپرم ساز یا به فضای بینابینی تزریق میشود. در ماه سوم پس از عمل PRP بیضه، تحریک گنادوتروپین در همسر بیمار در روزهای 2 تا 4 سیکل قاعدگی آغاز میشود. استخراج اسپرم با روش mTESE همزمان با روز بازیابی تخمک به منظور استفاده از سلول های اسپرم تازه انجام خواهد شد. در مرحله اول، 3 ماه پس از تزریق PRP به بیضه، آنالیز اسپرم در بیماران بررسی خواهد شد. مرحله دوم 6 ماه پس از تزریق خواهد بود. با توجه به نتایج به دست آمده، اسپرم توسط روشهای کمک باروری( ICSI) به سیتوپلاسم تخمک تزریق میشود و لقاح صورت میگیرد.
گروه مداخله: بیماران با آزواسپرمی غیر انسدادی با سابقه حداقل یک شکست در mTESE.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.جهت تهیه PRP، از کیت PRP (α-PRP - Celltech BiogenesisBD Vacutainer® Specialty Tubes, IranSKU:364606) استفاده خواهد شد. مدت زمان تهیه PRP کمتر از 45 دقیقه خواهد بود.PRP تهیه شده، با استفاده از سرنگ 5 ml5mL به داخل لوله اسپرم ساز یا به فضای بینابینی تزریق میشود. در ماه سوم پس از عمل PRP بیضه، تحریک گنادوتروپین در همسر بیمار در روزهای 2 تا 4 سیکل قاعدگی آغاز میشود. استخراج اسپرم با روش mTESE همزمان با روز بازیابی تخمک به منظور استفاده از سلول های اسپرم تازه انجام خواهد شد. در مرحله اول، 3 ماه پس از تزریق PRP به بیضه، آنالیز اسپرم در بیماران بررسی خواهد شد. مرحله دوم 6 ماه پس از تزریق خواهد بود. با توجه به نتایج به دست آمده، اسپرم توسط روشهای کمک باروری( ICSI) به سیتوپلاسم تخمک تزریق میشود و لقاح صورت میگیرد.
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Royan Institute
Name of organization / entity - Persian: پژوهشگاه رویان
Full name of responsible person - English: Marjan Sabbaghian
Full name of responsible person - Persian: مرجان صباغیان
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 25
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 12, Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran, Iran
Street address - Persian: بزرگراه شهید سلیمانی (رسالت)، انتهای خیابان بنیهاشم شمالی، خیابان حافظ شرقی، کوی رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1665659911
Phone: +98 21 2356 2000
Mobile: +98 912 835 2248
Fax:
Email: marjan.sabbaghian@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Royan Institute
Name of organization / entity - Persian: پژوهشگاه رویان
Full name of responsible person - English: Marjan Sabbaghian
Full name of responsible person - Persian: مرجان صباغیان
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 25
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran
Street address - Persian: بزرگراه شهید سلیمانی (رسالت)، انتهای خیابان بنیهاشم شمالی، خیابان حافظ شرقی، کوی رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1665659911
Phone: +98 21 2356 2000
Mobile: +98 912 835 2248
Fax:
Email: marjan.sabbaghian@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Royan Institute Name of organization / entity - Persian: پژوهشگاه رویان Full name of responsible person - English: Marjan Sabbaghian Full name of responsible person - Persian: مرجان صباغیان Position - English: Associate Professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 25 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 12, Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran, Iran Street address - Persian: بزرگراه شهید سلیمانی (رسالت)، انتهای خیابان بنیهاشم شمالی، خیابان حافظ شرقی، کوی رویان City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1665659911 Phone: +98 21 2356 2000 Mobile: +98 912 835 2248 Fax: Email: marjan.sabbaghian@gmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Royan Institute
Name of organization / entity - Persian: پژوهشگاه رویان
Full name of responsible person - English: Marjan Sabbaghian
Full name of responsible person - Persian: دکتر مرجان صباغیان
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 25
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 12, Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran, Iran
Street address - Persian: بزرگراه شهید سلیمانی (رسالت)، انتهای خیابان بنیهاشم شمالی، خیابان حافظ شرقی، کوی رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1665659911
Phone: +98 21 2356 2000
Mobile: +98 912 835 2248
Fax:
Email: marjan.sabbaghian@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Royan Institute
Name of organization / entity - Persian: پژوهشگاه رویان
Full name of responsible person - English: Marjan Sabbaghian
Full name of responsible person - Persian: دکتر مرجان صباغیان
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 25
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran
Street address - Persian: بزرگراه شهید سلیمانی (رسالت)، انتهای خیابان بنیهاشم شمالی، خیابان حافظ شرقی، کوی رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1665659911
Phone: +98 21 2356 2000
Mobile: +98 912 835 2248
Fax:
Email: marjan.sabbaghian@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Royan Institute Name of organization / entity - Persian: پژوهشگاه رویان Full name of responsible person - English: Marjan Sabbaghian Full name of responsible person - Persian: دکتر مرجان صباغیان Position - English: Associate professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 25 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 12, Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran, Iran Street address - Persian: بزرگراه شهید سلیمانی (رسالت)، انتهای خیابان بنیهاشم شمالی، خیابان حافظ شرقی، کوی رویان City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1665659911 Phone: +98 21 2356 2000 Mobile: +98 912 835 2248 Fax: Email: marjan.sabbaghian@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Royan Institute
Name of organization / entity - Persian: پژوهشگاه رویان
Full name of responsible person - English: Dr Marjan Sabbaghian
Full name of responsible person - Persian: دکتر مرجان صباغیان
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 25
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 12, Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran, Iran
Street address - Persian: بزرگراه شهید سلیمانی (رسالت)، انتهای خیابان بنیهاشم شمالی، خیابان حافظ شرقی، کوی رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1665659911
Phone: +98 21 2356 2000
Mobile: +98 912 835 2248
Fax:
Email: marjan.sabbaghian@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Royan Institute
Name of organization / entity - Persian: پژوهشگاه رویان
Full name of responsible person - English: Dr Marjan Sabbaghian
Full name of responsible person - Persian: دکتر مرجان صباغیان
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 25
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran
Street address - Persian: بزرگراه شهید سلیمانی (رسالت)، انتهای خیابان بنیهاشم شمالی، خیابان حافظ شرقی، کوی رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1665659911
Phone: +98 21 2356 2000
Mobile: +98 912 835 2248
Fax:
Email: marjan.sabbaghian@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Royan Institute Name of organization / entity - Persian: پژوهشگاه رویان Full name of responsible person - English: Dr Marjan Sabbaghian Full name of responsible person - Persian: دکتر مرجان صباغیان Position - English: Associate professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 25 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 12, Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran, Iran Street address - Persian: بزرگراه شهید سلیمانی (رسالت)، انتهای خیابان بنیهاشم شمالی، خیابان حافظ شرقی، کوی رویان City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1665659911 Phone: +98 21 2356 2000 Mobile: +98 912 835 2248 Fax: Email: marjan.sabbaghian@gmail.com Web page address:
Sharing plan
undecided
no
undecidedno
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
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.
Acronym
IRCT registration information
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
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
2024-06-16, 1403/03/27
Actual recruitment end date
2025-10-13, 1404/07/21
Trial completion date
2026-02-19, 1404/11/30
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
Actual sample size reached:
15
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.
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 ( 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.