The comparison of intra-uterine injection of autologous lymphocyte and platelet-rich plasma on the pregnancy rate in women with recurrent implantation failure
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Protocol summary
A clinical trial with 3 groups including control and platelet-rich plasma and mononuclear cells isolated from peripheral blood intervention groups, double-blind, randomized using a box of colored cards, will be conducted in phase 3 and on 90 patients.
A clinical trial with 3 groups including control and platelet-rich plasma and mononuclear cells isolated from peripheral blood intervention groups, double-blind, randomized using a box of colored cards, will be conducted in phase 3 and on 96 patients.
A clinical trial with 3 groups including control and platelet-rich plasma and mononuclear cells isolated from peripheral blood intervention groups, double-blind, randomized using a box of colored cards, will be conducted in phase 3 and on 9096 patients.
کارآزمایی بالینی دارای 3 گروه شامل کنترل و گروه های مداخله پلاسمای غنی از پلاکت و سلول های تک هسته ای جدا شده از خون محیطی، دوسویه کور، تصادفی شده با استفاده از جعبه کارت های رنگی، در فاز 3 و بر روی 90 بیمار انجام خواهد گرفت.
کارآزمایی بالینی دارای 3 گروه شامل کنترل و گروه های مداخله پلاسمای غنی از پلاکت و سلول های تک هسته ای جدا شده از خون محیطی، دوسویه کور، تصادفی شده با استفاده از جعبه کارت های رنگی، در فاز 3 و بر روی 96 بیمار انجام خواهد گرفت.
کارآزمایی بالینی دارای 3 گروه شامل کنترل و گروه های مداخله پلاسمای غنی از پلاکت و سلول های تک هسته ای جدا شده از خون محیطی، دوسویه کور، تصادفی شده با استفاده از جعبه کارت های رنگی، در فاز 3 و بر روی 9096 بیمار انجام خواهد گرفت.
This double-blinded study is conducted on patients with recurrent implantation failure referred to the Qom Jihad daneshgahi Infertility Treatment Center. Two days before embryo transfer, patients receive platelet-rich plasma or mononuclear cells isolated from peripheral blood intervention in order to compare their effect on embryo implantation rate. In this study, patients and doctors are not aware of the type of received intervention.
This Triple-blinded study is conducted on patients with recurrent implantation failure referred to the Qom Jihad daneshgahi Infertility Treatment Center. Two days before embryo transfer, patients receive platelet-rich plasma or mononuclear cells isolated from peripheral blood intervention in order to compare their effect on embryo implantation rate. In this study, patients and doctors are not aware of the type of received intervention.
This doubleTriple-blinded study is conducted on patients with recurrent implantation failure referred to the Qom Jihad daneshgahi Infertility Treatment Center. Two days before embryo transfer, patients receive platelet-rich plasma or mononuclear cells isolated from peripheral blood intervention in order to compare their effect on embryo implantation rate. In this study, patients and doctors are not aware of the type of received intervention.
این مطالعه دو سویه کور بر روی بیماران مبتلا به شکست مکرر لانه گزینی مراجعه کننده به مرکز درمان ناباروری جهاد دانشگاهی قم انجام می شود. بیماران دو روز پیش از انتقال جنین مداخله پلاسمای غنی از پلاکت یا سلول های تک هسته ای جدا شده از خون محیطی را به منظور مقایسه تاثیر آن ها در میزان لانه گزینی جنین دریافت میکنند. در این مطالعه بیماران و پزشکان از نوع مداخله دریافتی آگاه نیستند.
این مطالعه سه سویه کور بر روی بیماران مبتلا به شکست مکرر لانه گزینی مراجعه کننده به مرکز درمان ناباروری جهاد دانشگاهی قم انجام می شود. بیماران دو روز پیش از انتقال جنین مداخله پلاسمای غنی از پلاکت یا سلول های تک هسته ای جدا شده از خون محیطی را به منظور مقایسه تاثیر آن ها در میزان لانه گزینی جنین دریافت میکنند. در این مطالعه بیماران و پزشکان از نوع مداخله دریافتی آگاه نیستند.
این مطالعه دوسه سویه کور بر روی بیماران مبتلا به شکست مکرر لانه گزینی مراجعه کننده به مرکز درمان ناباروری جهاد دانشگاهی قم انجام می شود. بیماران دو روز پیش از انتقال جنین مداخله پلاسمای غنی از پلاکت یا سلول های تک هسته ای جدا شده از خون محیطی را به منظور مقایسه تاثیر آن ها در میزان لانه گزینی جنین دریافت میکنند. در این مطالعه بیماران و پزشکان از نوع مداخله دریافتی آگاه نیستند.
Biochemical pregnancy: through a quantitative beta-human chorionic gonadotropin pregnancy test assessed 9 days after 3-day embryo transfer and 7 days after blastocyst transfer.
Biochemical pregnancy: through a quantitative beta-human chorionic gonadotropin pregnancy test.
Biochemical pregnancy: through a quantitative beta-human chorionic gonadotropin pregnancy test assessed 9 days after 3-day embryo transfer and 7 days after blastocyst transfer.
حاملگی بیوشیمیایی: از طریق یک تست کمی حاملگی کوریونیک گنادوتروپین انسانی بتا که 9 روز پس از انتقال جنین 3 روزه و 7 روز پس از انتقال بلاستوسیست ارزیابی می شود.
حاملگی بیوشیمیایی: از طریق یک تست کمی حاملگی کوریونیک گنادوتروپین انسانی بتا
حاملگی بیوشیمیایی: از طریق یک تست کمی حاملگی کوریونیک گنادوتروپین انسانی بتا که 9 روز پس از انتقال جنین 3 روزه و 7 روز پس از انتقال بلاستوسیست ارزیابی می شود.
9 days after 3-day embryo transfer and 7 days after blastocyst transfer
2 weeks after embryo transfer
9 days2 weeks after 3-day embryo transfer and 7 days after blastocyst transfer
9 روز پس از انتقال جنین 3 روزه و 7 روز پس از انتقال بلاستوسیست
2 هفته پس از انتقال جنین
9 روز2 هفته پس از انتقال جنین 3 روزه و 7 روز پس از انتقال بلاستوسیست
quantitative beta-human chorionic gonadotropin pregnancy test
Quantitative beta-human chorionic gonadotropin pregnancy test
quantitativeQuantitative beta-human chorionic gonadotropin pregnancy test
#2
Four to five weeks after embryo transfer
Three to five weeks after embryo transfer
FourThree to five weeks after embryo transfer
چهار تا پنج هفته پس از انتقال جنین
سه تا پنج هفته پس از انتقال جنین
چهارسه تا پنج هفته پس از انتقال جنین
#3
Implantation rate: calculated as the number of gestational sacs/the number of transferred embryos, where gestational sacs is the number of gestational sacs observed at vaginal ultrasound 3–5 weeks after transfer and the number of transferred embryos is the number of transferred embryos.
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Implantation rate: calculated as the number of gestational sacs/the number of transferred embryos, where gestational sacs is the number of gestational sacs observed at vaginal ultrasound 3–5 weeks after transfer and the number of transferred embryos is the number of transferred embryos.
میزان لانه گزینی: به عنوان تعداد ساک های حاملگی/تعداد جنین های منتقل شده محاسبه می شود، که در آن ساک های حاملگی تعداد کیسه های بارداری مشاهده شده در سونوگرافی واژینال 3-5 هفته پس از انتقال و تعداد جنین های منتقل شده تعداد جنین های منتقل شده است.
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میزان لانه گزینی: به عنوان تعداد ساک های حاملگی/تعداد جنین های منتقل شده محاسبه می شود، که در آن ساک های حاملگی تعداد کیسه های بارداری مشاهده شده در سونوگرافی واژینال 3-5 هفته پس از انتقال و تعداد جنین های منتقل شده تعداد جنین های منتقل شده است.
Four to five weeks after embryo transfer
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Four to five weeks after embryo transfer
چهار تا پنج هفته پس از انتقال جنین
empty
چهار تا پنج هفته پس از انتقال جنین
calculating the number of gestational sacs/the number of transferred embryos
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calculating the number of gestational sacs/the number of transferred embryos
محاسبه تعداد ساک های حاملگی/تعداد جنین های منتقل شده
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محاسبه تعداد ساک های حاملگی/تعداد جنین های منتقل شده
Intervention groups
#1
Intervention group: in this group of patients with recurrent implantation failure, intrauterine platelet-rich plasma PRP is injected two days before embryo transfer. On the day of injection, about 20 ml of peripheral venous blood is drawn into a syringe containing 2.5 ml of citric acid anticoagulant solution and immediately centrifuged for 10-12 minutes at 1700 rpm to separate red blood cells. Then the plasma is centrifuged again at 3800 rpm for 7 minutes to obtain PRP, which contains 4-5 times more platelets than peripheral blood. 0.5 ml of the resulting PRP is injected into the uterine cavity with a transfer catheter.
Intervention group 1: in this group of patients with recurrent implantation failure, intrauterine platelet-rich plasma PRP is injected two days before embryo transfer. On the day of injection, about 30 ml of peripheral venous blood is drawn into a syringe containing 2.5 ml of citric acid anticoagulant solution and immediately centrifuged for 10-12 minutes at 1700 rpm to separate red blood cells. Then the plasma is centrifuged again at 3800 rpm for 7 minutes to obtain PRP, which contains 4-5 times more platelets than peripheral blood. 1 ml of the resulting PRP is injected into the uterine cavity with a transfer catheter.
Intervention group 1: in this group of patients with recurrent implantation failure, intrauterine platelet-rich plasma PRP is injected two days before embryo transfer. On the day of injection, about 2030 ml of peripheral venous blood is drawn into a syringe containing 2.5 ml of citric acid anticoagulant solution and immediately centrifuged for 10-12 minutes at 1700 rpm to separate red blood cells. Then the plasma is centrifuged again at 3800 rpm for 7 minutes to obtain PRP, which contains 4-5 times more platelets than peripheral blood. 0.51 ml of the resulting PRP is injected into the uterine cavity with a transfer catheter.
گروه مداخله: در این گروه بیماران مبتلا به شکست مکرر لانه گزینی دو روز پیش از انتقال جنین پلاسمای غنی از پلاکت (پی آر پی) داخل رحمی تزریق می شود. در روز تزریق حدود 20 میلی لیتر خون وریدی محیطی داخل سرنگی حاوی 2.5 میلی لیتر محلول ضد انعقاد اسید سیترات کشیده می شود و بلافاصله به مدت 12-10 دقیقه با دور 1700 سانتریفیوژ می شود تا گلبول های قرمز جدا گردد. سپس پلاسما دوباره با دور 3800 برای 7 دقیقه سانتریفیوژ می شود تا پی آر پی حاصل گردد که شامل 5-4 برابر پلاکت بیشتر نسبت به خون محیطی است. 0.5 میلی لیتر از پی آر پی حاصله با کاتتر انتقال به داخل حفره رحمی تزریق می شود.
گروه مداخله 1: در این گروه بیماران مبتلا به شکست مکرر لانه گزینی دو روز پیش از انتقال جنین پلاسمای غنی از پلاکت (پی آر پی) داخل رحمی تزریق می شود. در روز تزریق حدود 30 میلی لیتر خون وریدی محیطی داخل سرنگی حاوی 2.5 میلی لیتر محلول ضد انعقاد اسید سیترات کشیده می شود و بلافاصله به مدت 12-10 دقیقه با دور 1700 سانتریفیوژ می شود تا گلبول های قرمز جدا گردد. سپس پلاسما دوباره با دور 3800 برای 7 دقیقه سانتریفیوژ می شود تا پی آر پی حاصل گردد که شامل 5-4 برابر پلاکت بیشتر نسبت به خون محیطی است. 1 میلی لیتر از پی آر پی حاصله با کاتتر انتقال به داخل حفره رحمی تزریق می شود.
گروه مداخله 1: در این گروه بیماران مبتلا به شکست مکرر لانه گزینی دو روز پیش از انتقال جنین پلاسمای غنی از پلاکت (پی آر پی) داخل رحمی تزریق می شود. در روز تزریق حدود 2030 میلی لیتر خون وریدی محیطی داخل سرنگی حاوی 2.5 میلی لیتر محلول ضد انعقاد اسید سیترات کشیده می شود و بلافاصله به مدت 12-10 دقیقه با دور 1700 سانتریفیوژ می شود تا گلبول های قرمز جدا گردد. سپس پلاسما دوباره با دور 3800 برای 7 دقیقه سانتریفیوژ می شود تا پی آر پی حاصل گردد که شامل 5-4 برابر پلاکت بیشتر نسبت به خون محیطی است. 0.51 میلی لیتر از پی آر پی حاصله با کاتتر انتقال به داخل حفره رحمی تزریق می شود.
#2
Intervention group: in this group of patients with recurrent implantation failure, mononuclear cells isolated from peripheral blood (PBMC) are intra-uterine injected two days before embryo transfer. Blood samples are taken from patients on the day of ovulation induction and collected in citrate tubes in a volume of 3 ml for separation with Ficol solution. After centrifugation at 400 g for 30-40 min at 18-20 °C, a distinct layer of PBMC is obtained under the plasma medium. The PBMC layer was transferred to another tube and 3 volumes of phosphate buffer saline (PBS) were added to it, and then centrifuged at 60-100 g for 10 minutes at 18-20°C to obtain a cell pellet. The lymphocyte pellet was washed 2 times with PBS, and then cultured at 37°C. 72 hours after incubation and 2 days before embryo transfer, one million cells in 0.5 ml culture medium are transferred to the endometrial cavity.
Intervention group 2: A 3 ml blood sample is collected from RIF patients undergoing ART cycles on the day of ovulation induction and placed in citrated tubes to perform a separation based on the Ficoll solution. A separate layer of PBMC will appear under the median plasma after centrifugation at 18–20°C for 30–40 minutes at 400 g. The PBMC milky layer was transferred to another tube and washed twice with phosphate-buffered saline through centrifugation at 60–100 g for 10 minutes. The pellet was then resuspended in RPMI culture media with 75 IU of human menopausal gonadotropin (hMG) at 37°C. Two days before embryo transfer which coincided with 72 hours of incubation of PBMCs resulted in the development of cell clusters, 1–1.5× 10^6 cells in 0.5 ml medium were transferred into the endometrial cavity.
Intervention group 2: in this group ofA 3 ml blood sample is collected from RIF patients with recurrent implantation failure, mononuclear cells isolated from peripheral blood (PBMC) are intra-uterine injected two days before embryo transfer. Blood samples are taken from patientsundergoing ART cycles on the day of ovulation induction and collectedplaced in citratecitrated tubes into perform a volume of 3 ml for separation with Ficolbased on the Ficoll solution. After centrifugation at 400 g for 30-40 min at 18-20 °C, a distinctA separate layer of PBMC is obtainedwill appear under the median plasma mediumafter centrifugation at 18–20°C for 30–40 minutes at 400 g. The PBMC milky layer was transferred to another tube and 3 volumes ofwashed twice with phosphate buffer-buffered saline (PBS) were added to it, and then centrifugedthrough centrifugation at 60-–100 g for 10 minutes at 18-20°C to obtain a cell pellet. The lymphocyte pellet was washed 2 timesthen resuspended in RPMI culture media with PBS, and then cultured75 IU of human menopausal gonadotropin (hMG) at 37°C. 72 hours after incubation and 2Two days before embryo transfer which coincided with 72 hours of incubation of PBMCs resulted in the development of cell clusters, one million1–1.5× 10^6 cells in 0.5 ml culture medium arewere transferred tointo the endometrial cavity.
گروه مداخله: در این گروه بیماران مبتلا به شکست مکرر لانه گزینی دو روز پیش از انتقال جنین سلول های تک هسته ای جدا شده از خون محیطی (پی بی ام سی) بصورت داخل رحمی تزریق می شود. نمونه خون از بیماران در روز القای تخمک گذاری گرفته و برای جداسازی با محلول فایکول، به حجم 3 میلی لیتر در لوله های سیتراته جمع آوری می گردد. پس از سانتریفیوژ در g 400 برای 40-30 دقیقه در 20-18 درجه سانتیگراد، یک لایه مشخص از پی بی ام سی در زیر پلاسمای میانی بدست می آید. لایه پی بی ام سی به یک لوله دیگر منتقل و 3 حجم از فسفات بافر سالین (پی بی اس) به آن اضافه شده، و سپس سانتریفیوژ در g 100-60 برای 10 دقیقه 20-18 درجه سانتیگراد برای حصول پلت سلولی صورت می گیرد. پلت لنفوسیت 2 بار با پی بی اس شسته، و سپس در دمای 37 درجه سانتیگراد کشت داده میشود. 72 ساعت پس از انکوباسیون و 2 روز قبل از انتقال جنین، یک میلیون سلول در 0.5 میلی لیتر محیط کشت به حفره اندومتر منتقل می گردد.
گروه مداخله 2: یک نمونه 3 میلی لیتری خون از زنان RIF تحت سیکل ART در روز القای تخمک گذاری گرفته شده و در لوله سیتراته به منظور جداسازی با محلول فایکول قرار داده میشود. پس از سانتریفیوژ در g 400 برای 40-30 دقیقه در 20-18 درجه سانتیگراد، یک لایه مشخص از پی بی ام سی در زیر پلاسمای میانی بدست می آید. لایه شیری رنگ پی بی ام سی به یک لوله دیگر منتقل و دو بار با فسفات بافر سالین (پی بی اس) از طریق سانتریفیوژ در g 100-60 برای 10 دقیقه شستشو داده شد. سپس پلت مجددا در محیط کشت RPMI با IU 75 گنادوتروپین منوپوزال انسانی (hMG) و در دمای 37 درجه سانتیگراد کشت داده میشود. 2 روز قبل از انتقال جنین که مصادف است با 72 ساعت پس از انکوباسیون پی بی ام سی ها که باعث ایجاد کلاسترهای سلولی میشود، یک تا یک و نیم میلیون سلول در 0.5 میلی لیتر محیط کشت به حفره اندومتر منتقل می گردد.
گروه مداخله 2: در این گروه بیماران مبتلا به شکست مکرر لانه گزینی دو روز پیش از انتقال جنین سلول های تک هسته ای جدا شده از خون محیطی (پی بی ام سی) بصورت داخل رحمی تزریق می شود.یک نمونه 3 میلی لیتری خون از بیمارانزنان RIF تحت سیکل ART در روز القای تخمک گذاری گرفته شده و برایدر لوله سیتراته به منظور جداسازی با محلول فایکول، به حجم 3 میلی لیتر در لوله های سیتراته جمع آوری می گردد قرار داده میشود. پس از سانتریفیوژ در g 400 برای 40-30 دقیقه در 20-18 درجه سانتیگراد، یک لایه مشخص از پی بی ام سی در زیر پلاسمای میانی بدست می آید. لایه شیری رنگ پی بی ام سی به یک لوله دیگر منتقل و 3 حجم ازدو بار با فسفات بافر سالین (پی بی اس) به آن اضافه شده، و سپساز طریق سانتریفیوژ در g 100-60 برای 10 دقیقه 20-18 درجه سانتیگراد برای حصولشستشو داده شد. سپس پلت سلولی صورت می گیرد. پلت لنفوسیت 2 بارمجددا در محیط کشت RPMI با پی بی اس شسته،IU 75 گنادوتروپین منوپوزال انسانی (hMG) و سپس در دمای 37 درجه سانتیگراد کشت داده میشود. 72 ساعت پس از انکوباسیون و 2 روز قبل از انتقال جنین که مصادف است با 72 ساعت پس از انکوباسیون پی بی ام سی ها که باعث ایجاد کلاسترهای سلولی میشود، یک تا یک و نیم میلیون سلول در 0.5 میلی لیتر محیط کشت به حفره اندومتر منتقل می گردد.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Leila Naserpour
Full name of responsible person - Persian: لیلا ناصرپور
Position - English: Instructor
Position - Persian: مربی
Latest degree: phd
Area of specialty/work: 22
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St.
Street address - Persian: خیابان صفاشهر - کوچه جهاد دانشگاهی - ساختمان مرکزی جهاد دانشگاهی واحد استان قم
City - English: Qom
City - Persian: قم
Province: Ghoum
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3716986466
Phone: +98 25 3285 9856
Mobile: +98 912 346 3922
Fax:
Email: leilanasery48@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Leila Naserpour
Full name of responsible person - Persian: لیلا ناصرپور
Position - English: Instructor
Position - Persian: مربی
Latest degree: phd
Area of specialty/work: 22
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St.
Street address - Persian: خیابان صفاشهر، کوچه جهاد دانشگاهی، ساختمان مرکزی جهاد دانشگاهی واحد استان قم
City - English: Qom
City - Persian: قم
Province: Ghoum
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3716986466
Phone: +98 25 3285 9856
Mobile: +98 912 346 3922
Fax:
Email: leilanasery48@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Leila Naserpour Full name of responsible person - Persian: لیلا ناصرپور Position - English: Instructor Position - Persian: مربی Latest degree: phd Area of specialty/work: 22 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St. Street address - Persian: خیابان صفاشهر -، کوچه جهاد دانشگاهی -، ساختمان مرکزی جهاد دانشگاهی واحد استان قم City - English: Qom City - Persian: قم Province: Ghoum Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3716986466 Phone: +98 25 3285 9856 Mobile: +98 912 346 3922 Fax: Email: leilanasery48@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Azar Sheikholeslami
Full name of responsible person - Persian: آذر شیخ الاسلامی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St.
Street address - Persian: خیابان صفاشهر - کوچه جهاد دانشگاهی - ساختمان مرکزی جهاد دانشگاهی واحد استان قم
City - English: Qom
City - Persian: قم
Province: Ghoum
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3716986466
Phone: +98 25 3285 9856
Mobile: +98 912 750 6863
Fax:
Email: azareslami10@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Azar Sheikholeslami
Full name of responsible person - Persian: آذر شیخ الاسلامی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St.
Street address - Persian: خیابان صفاشهر، کوچه جهاد دانشگاهی، ساختمان مرکزی جهاد دانشگاهی واحد استان قم
City - English: Qom
City - Persian: قم
Province: Ghoum
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3716986466
Phone: +98 25 3285 9856
Mobile: +98 912 750 6863
Fax:
Email: azareslami10@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Azar Sheikholeslami Full name of responsible person - Persian: آذر شیخ الاسلامی Position - English: Assistant professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 49 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St. Street address - Persian: خیابان صفاشهر -، کوچه جهاد دانشگاهی -، ساختمان مرکزی جهاد دانشگاهی واحد استان قم City - English: Qom City - Persian: قم Province: Ghoum Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3716986466 Phone: +98 25 3285 9856 Mobile: +98 912 750 6863 Fax: Email: azareslami10@gmail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hoda Fazaeli
Full name of responsible person - Persian: هدی فضائلی
Position - English: Instructor
Position - Persian: مربی
Latest degree: phd
Area of specialty/work: 22
Area of specialty/work title - English: Developmental biology
Area of specialty/work title - Persian: زیست شناسی تکوینی
Street address - English: Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St.
Street address - Persian: خیابان صفاشهر - کوچه جهاد دانشگاهی - ساختمان مرکزی جهاد دانشگاهی واحد استان قم
City - English: Qom
City - Persian: قم
Province: Ghoum
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3716986466
Phone: +98 25 3285 9856
Mobile: +98 910 961 5049
Fax:
Email: hodafazaely@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hoda Fazaeli
Full name of responsible person - Persian: هدی فضائلی
Position - English: Instructor
Position - Persian: مربی
Latest degree: phd
Area of specialty/work: 22
Area of specialty/work title - English: Developmental biology
Area of specialty/work title - Persian: زیست شناسی تکوینی
Street address - English: Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St.
Street address - Persian: خیابان صفاشهر، کوچه جهاد دانشگاهی، ساختمان مرکزی جهاد دانشگاهی واحد استان قم
City - English: Qom
City - Persian: قم
Province: Ghoum
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3716986466
Phone: +98 25 3285 9856
Mobile: +98 910 961 5049
Fax:
Email: hodafazaely@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hoda Fazaeli Full name of responsible person - Persian: هدی فضائلی Position - English: Instructor Position - Persian: مربی Latest degree: phd Area of specialty/work: 22 Area of specialty/work title - English: Developmental biology Area of specialty/work title - Persian: زیست شناسی تکوینی Street address - English: Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St. Street address - Persian: خیابان صفاشهر -، کوچه جهاد دانشگاهی -، ساختمان مرکزی جهاد دانشگاهی واحد استان قم City - English: Qom City - Persian: قم Province: Ghoum Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3716986466 Phone: +98 25 3285 9856 Mobile: +98 910 961 5049 Fax: Email: hodafazaely@yahoo.com Web page address:
Sharing plan
E-mail the project manager and get permission
The data can only be used to inspire related studies for researchers, and the method of access is to send a request through an email address.
E-mailThe data can only be used to inspire related studies for researchers, and the project manager and get permissionmethod of access is to send a request through an email address.
ایمیل به مجری طرح و کسب اجازه
داده ها فقط به منظور الهام بخشی در مطالعات مرتبط برای محققین قابل استفاده است و روش دسترسی، ارسال درخواست از طریق آدرس ایمیل است.
ایمیلداده ها فقط به مجری طرحمنظور الهام بخشی در مطالعات مرتبط برای محققین قابل استفاده است و کسب اجازهروش دسترسی، ارسال درخواست از طریق آدرس ایمیل است.
Qom Jihad Daneshgahi
The responsible person will be the project manager at the email address leilanasery48@gmail.com.
Qom Jihad DaneshgahiThe responsible person will be the project manager at the email address leilanasery48@gmail.com.
جهاد دانشگاهی قم
فرد پاسخگو، مجری طرح به آدرس ایمیل leilanasery48@gmail.com خواهد بود.
جهاد دانشگاهی قمفرد پاسخگو، مجری طرح به آدرس ایمیل leilanasery48@gmail.com خواهد بود.
Protocol summary
Study aim
Providing a new treatment for patients with repeated implantation failure
Design
A clinical trial with 3 groups including control and platelet-rich plasma and mononuclear cells isolated from peripheral blood intervention groups, double-blind, randomized using a box of colored cards, will be conducted in phase 3 and on 96 patients.
Settings and conduct
This Triple-blinded study is conducted on patients with recurrent implantation failure referred to the Qom Jihad daneshgahi Infertility Treatment Center. Two days before embryo transfer, patients receive platelet-rich plasma or mononuclear cells isolated from peripheral blood intervention in order to compare their effect on embryo implantation rate. In this study, patients and doctors are not aware of the type of received intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: at least 2 implantation failures in IVF/ICSI; primary infertility; endometrial thickness less than 6 mm at the time of ovulation induction; age less than 40 years; regular menstrual cycles; body mass index <30; absence of uterine pathology and infection; unexplained infertility; tubular infertility
Exclusion criteria: polycystic ovary syndrome, uterine pathology, referring due to male infertility, presence of hydrosalpinx, presence of endometriosis.
Intervention groups
Patients are divided into 3 groups control, PRP, and mononuclear cells from peripheral blood intervention. The control group receives no treatment before embryo transfer, while 2 days before embryo transfer in the other two groups, PRP and mononuclear cells from peripheral blood will be injected into the uterine cavity by catheter.
Main outcome variables
Biochemical pregnancy; clinical pregnancy
General information
Reason for update
Corrections
Acronym
IRCT registration information
IRCT registration number:IRCT20221010056132N1
Registration date:2022-10-31, 1401/08/09
Registration timing:prospective
Last update:2024-07-11, 1403/04/21
Update count:3
Registration date
2022-10-31, 1401/08/09
Registrant information
Name
Hoda Fazaeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3270 0152
Email address
hodafazaely@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2024-01-05, 1402/10/15
Actual recruitment start date
2022-11-11, 1401/08/20
Actual recruitment end date
2023-12-06, 1402/09/15
Trial completion date
2024-03-05, 1402/12/15
Scientific title
The comparison of intra-uterine injection of autologous lymphocyte and platelet-rich plasma on the pregnancy rate in women with recurrent implantation failure
Public title
The effect of intra-uterine injection of autologous lymphocyte and platelet-rich plasma on the pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Experience at least 2 implantation failures in IVF/ICSI
Primary infertility
Endometrial thickness less than 6 mm at the time of ovulation induction
Age less than 40 years
Regular menstrual cycles
Body mass index<30
Absence of uterine pathology and infection
unexplained infertility
Infertility with tubal causes
Exclusion criteria:
Polycystic ovary syndrome
Uterine pathology
Referring due to male infertility
Presence of hydrosalpinx
Presence of endometriosis.
Age
To 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
96
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The way of randomization is that 96 colored cards with white, blue, and red colors - 32 of each - are placed in a box. After accepting each patient and obtaining informed consent, the specialist randomly takes one of the colored cards inside the box (without seeing the contents of the box) and in this way, they are classified into different groups. So the white color will represent the control group, the blue color will represent the lymphocyte therapy group, and the red color will represent the PRP therapy group. The control group receives the embryos formed after IVF/ICSI treatment without any other special treatment. The red and blue groups receive PRP and PBMC intervention as an intra-uterine injection 2 days before embryo transfer, respectively, in order to investigate the effect of PRP and PBMC on embryo implantation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The method of blinding will be in such a way that the patient is unaware of the type of treatment she will receive and since the doctor who puts the patient in the cycle, the doctor who performs lymphocyte therapy or PRP therapy, and finally, the doctor who carries out the embryo transfer are different people, the embryo transfer is done without knowing about the treatment that the patient has done two days before the transfer so that knowing this issue does not affect the way of their embryo transfer. It should be noted that none of the mentioned doctors will do the statistical analysis of the obtained data and the statistical analysis will be done by another researcher who is unaware of the type of treatment received by the different groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iranian academic center for education, culture and research
Street address
Secretariat of Ethics in Academic Jihad Research, Research and Technology Vice-Chancellor, No. 1270, In front of the main door of Tehran University, Enghelab st, Tehran
City
Tehran
Province
Tehran
Postal code
1314744513
Approval date
2019-11-17, 1398/08/26
Ethics committee reference number
IR.ACECR.REC.1398.002
Health conditions studied
1
Description of health condition studied
Recurrent implantation failure
ICD-10 code
Z35.0
ICD-10 code description
Supervision of pregnancy with history of infertility
Primary outcomes
1
Description
Biochemical pregnancy: through a quantitative beta-human chorionic gonadotropin pregnancy test.
Timepoint
2 weeks after embryo transfer
Method of measurement
Quantitative beta-human chorionic gonadotropin pregnancy test
2
Description
Clinical pregnancy: pregnancy confirmed by high levels of human chorionic gonadotropin-beta and ultrasound confirmation of pregnancy sac or heartbeat.
Timepoint
Three to five weeks after embryo transfer
Method of measurement
Vaginal ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Control group: transfer of embryos in this group of patients with recurrent implantation failure after being placed in the cycle of ovarian induction, is done without any intervention.
Category
Treatment - Other
2
Description
Intervention group 1: in this group of patients with recurrent implantation failure, intrauterine platelet-rich plasma PRP is injected two days before embryo transfer. On the day of injection, about 30 ml of peripheral venous blood is drawn into a syringe containing 2.5 ml of citric acid anticoagulant solution and immediately centrifuged for 10-12 minutes at 1700 rpm to separate red blood cells. Then the plasma is centrifuged again at 3800 rpm for 7 minutes to obtain PRP, which contains 4-5 times more platelets than peripheral blood. 1 ml of the resulting PRP is injected into the uterine cavity with a transfer catheter.
Category
Treatment - Other
3
Description
Intervention group 2: A 3 ml blood sample is collected from RIF patients undergoing ART cycles on the day of ovulation induction and placed in citrated tubes to perform a separation based on the Ficoll solution. A separate layer of PBMC will appear under the median plasma after centrifugation at 18–20°C for 30–40 minutes at 400 g. The PBMC milky layer was transferred to another tube and washed twice with phosphate-buffered saline through centrifugation at 60–100 g for 10 minutes. The pellet was then resuspended in RPMI culture media with 75 IU of human menopausal gonadotropin (hMG) at 37°C. Two days before embryo transfer which coincided with 72 hours of incubation of PBMCs resulted in the development of cell clusters, 1–1.5× 10^6 cells in 0.5 ml medium were transferred into the endometrial cavity.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Highly Specialized Infertility Treatment Center of Qom Jihad Daneshgahi
Full name of responsible person
Leila Naserpour
Street address
Highly Specialized Infertility Treatment Center of Qom Jihad Daneshgahi, Shabnam st, Isar Sq, Shahid Karimi Blvd
City
Qom
Province
Ghoum
Postal code
3713189934
Phone
+98 25 3270 0155
Fax
+98 25 3270 0154
Email
leilanasery48@gmail.com
Web page address
https://www.rooyaivf.ir/fa/?page_id=1849
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Leila Naserpour
Street address
Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St.
City
Qom
Province
Ghoum
Postal code
3716986466
Phone
+98 25 3285 9856
Email
leilanasery48@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
100
Public or private sector
Private
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
Iranian academic center for education culture and research
Full name of responsible person
Leila Naserpour
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St.
City
Qom
Province
Ghoum
Postal code
3716986466
Phone
+98 25 3285 9856
Email
leilanasery48@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Azar Sheikholeslami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St.
City
Qom
Province
Ghoum
Postal code
3716986466
Phone
+98 25 3285 9856
Email
azareslami10@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Hoda Fazaeli
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Developmental biology
Street address
Central Building of Jihad Academic Qom Province Branch, Jihad Academic Alley, Safashehr St.
City
Qom
Province
Ghoum
Postal code
3716986466
Phone
+98 25 3285 9856
Email
hodafazaely@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Only part of the data, such as the main outcome information, can be published
When the data will become available and for how long
The access period starts after the publication of the results
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can only be used to inspire related studies for researchers, and the method of access is to send a request through an email address.
From where data/document is obtainable
The responsible person will be the project manager at the email address leilanasery48@gmail.com.
What processes are involved for a request to access data/document