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Protocol summary
Implantation is considered to be successful when the sac can be detected by ultrasound. Platelet-rich plasma (PRP) has been able to stimulate endometrial growth and improve the outcome of pregnancy in patients with repeated implantation failure.
This research team carry out a randomized double blind controlled trial, with 50 cases in two intervention and control groups, with the aim of determining the effect of platelet-rich plasma on the improvement of pregnancy outcomes in patients with repeated implantation failure.
Study Population: Patients referred to the ACECR Center for Infertility Therapy, who had repeated implantation failure.
Intervention: Intrauterine injection of autologous platelet-rich plasma.
After obtaining informed consent, patients will undergo standardized fertility treatment. Endometrial thickness is measured by trans vaginal ultrasound. In the intervention group, intrauterine injections of PRP are performed. PRP is prepared from autologous blood by centrifugation, and 0.5-1 ml of PRP is injected into the uterine cavity. After 48 hours of PRP injection, the embryos are transferred to the uterine cavity in the blastocyst stage. In the control group, the standard treatment will done to transfer the embryo to the uterine cavity without intrauterine infusion of PRP. After 4 weeks, the level of hormones βHCG is measured in the blood sample of patients and pregnancy is confirmed by ultrasound examination. The patient is followed for 3 weeks to observe the embryonic heart rate and continue to monitor the pregnancy process.
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Implantation is considered to be successful when the sac can be detected by ultrasound. Platelet-rich plasma (PRP) has been able to stimulate endometrial growth and improve the outcome of pregnancy in patients with repeated implantation failure. This research team carry out a randomized double blind controlled trial, with 50 cases in two intervention and control groups, with the aim of determining the effect of platelet-rich plasma on the improvement of pregnancy outcomes in patients with repeated implantation failure. Study Population: Patients referred to the ACECR Center for Infertility Therapy, who had repeated implantation failure. Intervention: Intrauterine injection of autologous platelet-rich plasma. After obtaining informed consent, patients will undergo standardized fertility treatment. Endometrial thickness is measured by trans vaginal ultrasound. In the intervention group, intrauterine injections of PRP are performed. PRP is prepared from autologous blood by centrifugation, and 0.5-1 ml of PRP is injected into the uterine cavity. After 48 hours of PRP injection, the embryos are transferred to the uterine cavity in the blastocyst stage. In the control group, the standard treatment will done to transfer the embryo to the uterine cavity without intrauterine infusion of PRP. After 4 weeks, the level of hormones βHCG is measured in the blood sample of patients and pregnancy is confirmed by ultrasound examination. The patient is followed for 3 weeks to observe the embryonic heart rate and continue to monitor the pregnancy process.
لانه گزینی زمانی موفق در نظر گرفته می شود که ساک حاملگی توسط سونوگرافی تشخیص داده شود. پلاسمای غنی از پلاکت (PRP) قادر به تحریک رشد آندومتر و بهبود پیامد بارداری در بیماران دچار شکست مکرر لانه گزینی بوده است.
این تیم درمانی تحقیقاتی در نظر دارد مطالعه کارازمایی بالینی شاهد دار تصادفی شده دوسو کور با حجم نمونه 50 مورد در دو گروه مداخله و کنترل با هدف تعیین تاثیر پلاسمای غنی از پلاکت در بهبود نتایج بارداری دربیماران دچار شکست مکرر لانه گزینی
انجام دهد.
جمعیت مورد مطالعه: :مراجعین مرکز درمان ناباروری جهاددانشگاهی که طی درمان کمک باروری دچار شکست مکرر در لانه گزینی شده اند.
مداخله :تزریق داخل رحمی پلاسمای غنی از پلاکت اتولوگ
پس از اخذ رضایت نامه کتبی ،بیماران تحت درمان استاندارد کمک باروری قرار خواهند گرفت.ضخامت اندومتر توسط سونوگرافی ترانس واژینال اندازه گیری میشود. در بیماران گروه مداخله ،تزریق داخل رحمی PRP اتولوگ انجام می شود. PRP از خون اتولوگ توسط سانتریفوژ، آماده شده و 0.5-1 میلی لیتر از PRP به داخل حفره رحم تزریق میشود. بعد از 48 ساعت از تزریق PRP؛ جنین ها در مرحله بلاستوسیست به داخل حفره رحم منتقل می شوند.در بیماران گروه کنترل درمان استاندارد انتقال جنین به حفره رحم بدون تزریق داخل رحمی PRP صورت میگیرد.پس از گذشت 4 هفته از این درمان سطح هورمون βHCG در خون بیماران اندازه گیری شده و با سونوگرافی رویت ساک حاملگی تایید میگردد.پیگیری بیمار بعد از 3 هفته جهت رویت ضربان قلب جنین و ادامه پایش روند بارداری صورت می پذیرد.
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لانه گزینی زمانی موفق در نظر گرفته می شود که ساک حاملگی توسط سونوگرافی تشخیص داده شود. پلاسمای غنی از پلاکت (PRP) قادر به تحریک رشد آندومتر و بهبود پیامد بارداری در بیماران دچار شکست مکرر لانه گزینی بوده است. این تیم درمانی تحقیقاتی در نظر دارد مطالعه کارازمایی بالینی شاهد دار تصادفی شده دوسو کور با حجم نمونه 50 مورد در دو گروه مداخله و کنترل با هدف تعیین تاثیر پلاسمای غنی از پلاکت در بهبود نتایج بارداری دربیماران دچار شکست مکرر لانه گزینی انجام دهد. جمعیت مورد مطالعه: :مراجعین مرکز درمان ناباروری جهاددانشگاهی که طی درمان کمک باروری دچار شکست مکرر در لانه گزینی شده اند. مداخله :تزریق داخل رحمی پلاسمای غنی از پلاکت اتولوگ پس از اخذ رضایت نامه کتبی ،بیماران تحت درمان استاندارد کمک باروری قرار خواهند گرفت.ضخامت اندومتر توسط سونوگرافی ترانس واژینال اندازه گیری میشود. در بیماران گروه مداخله ،تزریق داخل رحمی PRP اتولوگ انجام می شود. PRP از خون اتولوگ توسط سانتریفوژ، آماده شده و 0.5-1 میلی لیتر از PRP به داخل حفره رحم تزریق میشود. بعد از 48 ساعت از تزریق PRP؛ جنین ها در مرحله بلاستوسیست به داخل حفره رحم منتقل می شوند.در بیماران گروه کنترل درمان استاندارد انتقال جنین به حفره رحم بدون تزریق داخل رحمی PRP صورت میگیرد.پس از گذشت 4 هفته از این درمان سطح هورمون βHCG در خون بیماران اندازه گیری شده و با سونوگرافی رویت ساک حاملگی تایید میگردد.پیگیری بیمار بعد از 3 هفته جهت رویت ضربان قلب جنین و ادامه پایش روند بارداری صورت می پذیرد.
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determining the effect of platelet rich plasma on the improvement of pregnancy outcomes in repeated implantation failure
determining the effect of platelet rich plasma on the improvement of pregnancy outcomes in repeated implantation failure
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تعیین تاثیر پلاسمای غنی از پلاکت دربهبود نتایج بارداری در شکست مکرر لانه گزینی
تعیین تاثیر پلاسمای غنی از پلاکت دربهبود نتایج بارداری در شکست مکرر لانه گزینی
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A randomized; double-blind; controlled trial, with 118 cases in two intervention or control groups, parallel-group, phase 3, randomization with use of sealed envelopes.
A randomized; double-blind; controlled trial, with 118 cases in two intervention or control groups, parallel-group, phase 3, randomization with use of sealed envelopes.
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مطالعه کارازمایی بالینی شاهد دار تصادفی شده دوسو کور با حجم نمونه 118 مورد در دو گروه مداخله و کنترل،با گروههای موازی ،دو سویه کور فاز 3، برای تصادفی سازی از پاکت های مهروموم شده استفاده شد.
مطالعه کارازمایی بالینی شاهد دار تصادفی شده دوسو کور با حجم نمونه 118 مورد در دو گروه مداخله و کنترل،با گروههای موازی ،دو سویه کور فاز 3، برای تصادفی سازی از پاکت های مهروموم شده استفاده شد.
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Tabriz jihad daneshgahi ART center, Endometrial thickness is measured by trans vaginal ultrasound. In the intervention group, intrauterine injections of PRP are performed. PRP is prepared from autologous blood by centrifugation, and 0.5 to1 ml of PRP is injected into the uterine cavity. After 48 hours of PRP injection, the embryos are transferred to the uterine cavity in the blastocyst stage. In the control group, the standard treatment will done to transfer the embryo to the uterine cavity without intrauterine infusion of PRP.
Tabriz jihad daneshgahi ART center, Endometrial thickness is measured by trans vaginal ultrasound. In the intervention group, intrauterine injections of PRP are performed. PRP is prepared from autologous blood by centrifugation, and 0.5 to1 ml of PRP is injected into the uterine cavity. After 48 hours of PRP injection, the embryos are transferred to the uterine cavity in the blastocyst stage. In the control group, the standard treatment will done to transfer the embryo to the uterine cavity without intrauterine infusion of PRP.
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مرکز درمان ناباروری جهاددانشگاهی تبریز-ضخامت اندومتر توسط سونوگرافی ترانس واژینال اندازه گیری میشود. در بیماران گروه مداخله ،تزریق داخل رحمی PRP اتولوگ انجام می شود. PRP از خون اتولوگ توسط سانتریفوژ، آماده شده و 0.5تا 1 میلی لیتر از PRP به داخل حفره رحم تزریق میشود. بعد از 48 ساعت از تزریق PRP؛ جنین ها در مرحله بلاستوسیست به داخل حفره رحم منتقل می شوند.در بیماران گروه کنترل درمان استاندارد انتقال جنین به حفره رحم بدون تزریق داخل رحمی PRP صورت میگیرد
مرکز درمان ناباروری جهاددانشگاهی تبریز-ضخامت اندومتر توسط سونوگرافی ترانس واژینال اندازه گیری میشود. در بیماران گروه مداخله ،تزریق داخل رحمی PRP اتولوگ انجام می شود. PRP از خون اتولوگ توسط سانتریفوژ، آماده شده و 0.5تا 1 میلی لیتر از PRP به داخل حفره رحم تزریق میشود. بعد از 48 ساعت از تزریق PRP؛ جنین ها در مرحله بلاستوسیست به داخل حفره رحم منتقل می شوند.در بیماران گروه کنترل درمان استاندارد انتقال جنین به حفره رحم بدون تزریق داخل رحمی PRP صورت میگیرد
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Inclusion criteria: women 18-45 years old; with a history of RIF during ART treatments. Exclusion criteria: pregnancy, diagnosed cancers, hemoglobin less than 11 gr per decilitre, platelets less than 150,000 per cc, use of anticoagulants, use of NSAID up to 10 days before the procedure, any physical or mental illness that affects the participant's immunity and admission.
Inclusion criteria: women 18-45 years old; with a history of RIF during ART treatments. Exclusion criteria: pregnancy, diagnosed cancers, hemoglobin less than 11 gr per decilitre, platelets less than 150,000 per cc, use of anticoagulants, use of NSAID up to 10 days before the procedure, any physical or mental illness that affects the participant's immunity and admission.
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معیارهای ورود خانم های در سن باروری (18-45 سال)با سابقه شکست مکرر لانه گزینی طی روند درمان های ART میباشد. معیارهای خروج از مطالعه شامل حاملگی ،کانسر تشخیص داده شده،هموگلوبین کمتر از 11گرم بر دسی لیتر،پلاکت کمتر از 150000در سی سی ، مصرف داروهای ضد انعقاد، مصرف NSAID تا 10 روز قبل از پروسیجر، هرنوع بیماری جسمانی یا روانی که ایمنی و پذیرش بیمار را تحت تاثیر قرار دهد و در روند اجرای طرح و پیگیری بیمار اختلال ایجاد کند، می باشد.
معیارهای ورود خانم های در سن باروری (18-45 سال)با سابقه شکست مکرر لانه گزینی طی روند درمان های ART میباشد. معیارهای خروج از مطالعه شامل حاملگی ،کانسر تشخیص داده شده،هموگلوبین کمتر از 11گرم بر دسی لیتر،پلاکت کمتر از 150000در سی سی ، مصرف داروهای ضد انعقاد، مصرف NSAID تا 10 روز قبل از پروسیجر، هرنوع بیماری جسمانی یا روانی که ایمنی و پذیرش بیمار را تحت تاثیر قرار دهد و در روند اجرای طرح و پیگیری بیمار اختلال ایجاد کند، می باشد.
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Intervention group: Intrauterine injection of autologous platelet rich plasma;
control group: standardized fertility treatment
Intervention group: Intrauterine injection of autologous platelet rich plasma; control group: standardized fertility treatment
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گروه مداخله :تزریق داخل رحمی پلاسمای غنی از پلاکت اتولوگ ؛ ،گروه کنترل تحت درمان استاندارد کمک باروری قرار خواهند گرفت.
گروه مداخله :تزریق داخل رحمی پلاسمای غنی از پلاکت اتولوگ ؛ ،گروه کنترل تحت درمان استاندارد کمک باروری قرار خواهند گرفت.
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Blood βHCG hormone; pregnancy sac and fetus heart rate in sonography
Blood βHCG hormone; pregnancy sac and fetus heart rate in sonography
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سطح هورمون βHCG خون؛ رویت ساک حاملگی با سونوگرافی؛ رویت ضربان قلب جنین با سونوگرافی
سطح هورمون βHCG خون؛ رویت ساک حاملگی با سونوگرافی؛ رویت ضربان قلب جنین با سونوگرافی
General information
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50
118
50118
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94
94
2017-10-07, 1396/07/15
2017-05-01, 1396/02/11
2017-1005-0701 00:00:00
2018-03-06, 1396/12/15
2018-02-01, 1396/11/12
2018-0302-0601 00:00:00
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2017-05-01, 1396/02/11
2017-05-01 00:00:00
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2018-02-01, 1396/11/12
2018-02-01 00:00:00
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2018-02-01, 1396/11/12
2018-02-01 00:00:00
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data correction about sample size and IRCT update
data correction about sample size and IRCT update
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اصلاح اطلاعات در مورد حجم نمونه و بروز رسانی سایت کارازمایی بالینی
اصلاح اطلاعات در مورد حجم نمونه و بروز رسانی سایت کارازمایی بالینی
Women of childbearing age (18-45 yrs)
A history of RIF (repeated implantation failure) during ART(Assisted reproductive technology ) treatments
Women of childbearing age (18-45 yrs) A history of RIF (repeated implantation failure) during ART(Assisted reproductive technology ) treatments
خانم های در سن باروری بین 18 تا 45 ساله
سابقه شکست مکرر لانه گزینی با درمانهای کمک باروری
خانم های در سن باروری بین 18 تا 45 ساله سابقه شکست مکرر لانه گزینی با درمانهای کمک باروری
pregnancy,
Diagnosed cancers,
Hemoglobin less than 11 gr per deciliter,
Patelets less than 150,000/ cc,
Use of anticoagulants,
Use of Non-steroidal anti-inflammatory drugs up to 10 days before the procedure,
Any physical or mental illness that affects the patient's immunity and admission and disrupts the process of project implementation and patient follow-up.
pregnancy, Diagnosed cancers, Hemoglobin less than 11 gr per deciliter, Patelets less than 150,000/ cc, Use of anticoagulants, Use of Non-steroidal anti-inflammatory drugs up to 10 days before the procedure, Any physical or mental illness that affects the patient's immunity and admission and disrupts the process of project implementation and patient follow-up.
بارداری
ابتلا به کانسر تشخیص داده شده،
هموگلوبین کمتر از 11 گرم در دسی لیتر،
مصرف داروهای ضد انعقاد،
مصرف داروهای ضدالتهاب غیراستروئیدی ده روز قبل از انجام پروسیجر،
وجود هرگونه بیماری جسمی و روحی که سیستم ایمنی و پذیرش یا رد بیمار را نسبت به روند مطالعه و پیگیری مختل کند.
بارداری ابتلا به کانسر تشخیص داده شده، هموگلوبین کمتر از 11 گرم در دسی لیتر، مصرف داروهای ضد انعقاد، مصرف داروهای ضدالتهاب غیراستروئیدی ده روز قبل از انجام پروسیجر، وجود هرگونه بیماری جسمی و روحی که سیستم ایمنی و پذیرش یا رد بیمار را نسبت به روند مطالعه و پیگیری مختل کند.
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The method is simple randomization and using the tool of sealed envelopes. Participants select one of the envelopes and deliver it to the relevant observer. The letters A and B are written inside the envelope and the participants are divided into two groups.
The method is simple randomization and using the tool of sealed envelopes. Participants select one of the envelopes and deliver it to the relevant observer. The letters A and B are written inside the envelope and the participants are divided into two groups.
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روش تصادفی سازی ساده و استفاده از ابزار پاکت های مهرو موم شده می باشد. بیماران یکی از پاکت ها را انتخاب کرده و به مسئول مربوطه تحویل می دهند. داخل پاکت حروف A,B نوشته شده و بیماران به دو گروه تخصیص می یابند.
روش تصادفی سازی ساده و استفاده از ابزار پاکت های مهرو موم شده می باشد. بیماران یکی از پاکت ها را انتخاب کرده و به مسئول مربوطه تحویل می دهند. داخل پاکت حروف A,B نوشته شده و بیماران به دو گروه تخصیص می یابند.
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Patients are unaware of the assignment to the groups. The examining physician and sonographer are unaware of the assignment of the patient to the groups. The analyzer is only aware of groups A and B and is not aware of the control and intervention group.
Patients are unaware of the assignment to the groups. The examining physician and sonographer are unaware of the assignment of the patient to the groups. The analyzer is only aware of groups A and B and is not aware of the control and intervention group.
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بیماران از تخصیص به گروه ها بی اطلاع هستند.پزشک معاینه کننده و سونوگرافی کننده از تخصیص بیمار به گروه ها بی اطلاع است.انالیز کننده فقط از گروه A,B مطلع است و از گروه کنترل و مداخله آگاه نیست.
بیماران از تخصیص به گروه ها بی اطلاع هستند.پزشک معاینه کننده و سونوگرافی کننده از تخصیص بیمار به گروه ها بی اطلاع است.انالیز کننده فقط از گروه A,B مطلع است و از گروه کنترل و مداخله آگاه نیست.
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Primary outcomes
#1
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check the fetus heart rate ,
check the fetus heart rate ,
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رویت ضربان قلب جنین
رویت ضربان قلب جنین
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3 weeks after the check of positive HCG
3 weeks after the check of positive HCG
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,سه هفته بعد از مثبت شدن HCG
,سه هفته بعد از مثبت شدن HCG
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sonography
sonography
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سونوگرافی
سونوگرافی
Intervention groups
#1
Intervention group: Intrauterine injection of autologous platelet-rich plasma. After 48 hours, the embryo is transferred to the uterine cavity.
intervention group: Injection of autologous platelet-rich plasma into the uterine cavity before embryos are transferred into the uterine cavity
Interventionintervention group: Intrauterine injectionInjection of autologous platelet-rich plasma. After 48 hours, the embryo is transferred to into the uterine cavity. before embryos are transferred into the uterine cavity
گروه مداخله: تزریق داخل رحمی پلاسمای غنی از پلاکت اتولوگ بعد از 48 ساعت جنین هابه داخل حفره رحم منتقل می شوند.
گروه مداخله: تزریق پلاسمای غنی از پلاکت اتولوگ به داخل حفره رحم قبل از انتقال جنین ها به داخل حفره رحم
گروه مداخله: تزریق داخل رحمی پلاسمای غنی از پلاکت اتولوگ بعد از 48 ساعت جنین هابهبه داخل حفره رحم منتقل می شوند.قبل از انتقال جنین ها به داخل حفره رحم
Recruitment centers
#1
Name of recruitment center - English: East Azarbaijan ACECR infertility treatment center
Name of recruitment center - Persian: مرکز درمان ناباروری جهاد دانشگاهی آذربایجان شرقی
Full name of responsible person - English: Dr Elaheh Baybordi
Full name of responsible person - Persian: دکتر الهه بایبوردی
Street address - English: East Azarbaijan ACECR infertility treatment center, Jaam e Jam AVE
Street address - Persian: تبریز،خیابان جام جم،مرکز درمان ناباروری جهاد دانشگاهی آذربایجان شرقی
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: East Azarbaijan ACECR infertility treatment center
Name of recruitment center - Persian: مرکز درمان ناباروری جهاد دانشگاهی آذربایجان شرقی
Full name of responsible person - English: Dr Elaheh Baybordi
Full name of responsible person - Persian: دکتر الهه بایبوردی
Street address - English: East Azarbaijan ACECR infertility treatment center, Jaam e Jam AVE
Street address - Persian: تبریز،خیابان جام جم،مرکز درمان ناباروری جهاد دانشگاهی آذربایجان شرقی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5163963173
Phone: +98 41 3332 5730
Fax:
Email: baybordi@acecr.ac.ir
Web page address:
Name of recruitment center - English: East Azarbaijan ACECR infertility treatment center Name of recruitment center - Persian: مرکز درمان ناباروری جهاد دانشگاهی آذربایجان شرقی Full name of responsible person - English: Dr Elaheh Baybordi Full name of responsible person - Persian: دکتر الهه بایبوردی Street address - English: East Azarbaijan ACECR infertility treatment center, Jaam e Jam AVE Street address - Persian: تبریز،خیابان جام جم،مرکز درمان ناباروری جهاد دانشگاهی آذربایجان شرقی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5163963173 Phone: +98 41 3332 5730 Fax: Email: baybordi@acecr.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: East Azarbaijan ACECR
Name of organization / entity - Persian: سازمان جهاد دانشگاهی آذربایجان شرقی
Full name of responsible person - English: Dr. Jafar Mohseni
Full name of responsible person - Persian: دکتر جعفر محسنی
Street address - English: ACECR Research center, Do Kamal Ave.
Street address - Persian: خیابان دوکمال، مرکز تحقیقات جهاد دانشگاهی
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Jafar Mohseni
Full name of responsible person - Persian: دکتر جعفر محسنی
Street address - English: ACECR Research center, Do Kamal Ave.
Street address - Persian: خیابان دوکمال، مرکز تحقیقات جهاد دانشگاهی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5163963173
Phone: +98 41 3658 8229
Fax:
Email: baybordi@acecr.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: East Azarbaijan ACECR Name of organization / entity - Persian: سازمان جهاد دانشگاهی آذربایجان شرقی Full name of responsible person - English: Dr. Jafar Mohseni Full name of responsible person - Persian: دکتر جعفر محسنی Street address - English: ACECR Research center, Do Kamal Ave. Street address - Persian: خیابان دوکمال، مرکز تحقیقات جهاد دانشگاهی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5163963173 Phone: +98 41 3658 8229 Fax: Email: baybordi@acecr.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
East Azarbaijan ACECR
Iranian academic center for education culture and research
East Azarbaijan ACECRIranian academic center for education culture and research
سازمان جهاد دانشگاهی آذربایجان شرقی
جهاد دانشگاهی
سازمان جهاد دانشگاهی آذربایجان شرقی
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: ACECR
Name of organization / entity - Persian: سازمان جهاد دانشگاهی
Full name of responsible person - English: Dr Jafar zadeh
Full name of responsible person - Persian: دکتر جعفر زاده
Position - English: ACECR Infertility treatment center managment
Position - Persian: مدیر مرکز درمان ناباروری جهاد دانشگاهی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: ACECR Infertility treatment center,Jame Jam AVE
Street address - Persian: خیابان جام جم،مرکز درمان ناباروری جهاد دانشگاهی
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3329 5730
Mobile: +98 914 107 5338
Fax:
Email: s.jaafarzade@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: ACECR
Name of organization / entity - Persian: سازمان جهاد دانشگاهی
Full name of responsible person - English: Dr Jafarzadeh
Full name of responsible person - Persian: دکتر جعفر زاده
Position - English: ACECR Infertility treatment center managment
Position - Persian: مدیر مرکز درمان ناباروری جهاد دانشگاهی
Latest degree: phd
Area of specialty/work: 22
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: ACECR Infertility treatment center,Jame Jam AVE
Street address - Persian: خیابان جام جم،مرکز درمان ناباروری جهاد دانشگاهی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5163963173
Phone: +98 41 3329 5730
Mobile: +98 914 107 5338
Fax:
Email: sjafarzadeh@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: ACECR Name of organization / entity - Persian: سازمان جهاد دانشگاهی Full name of responsible person - English: Dr Jafar zadehJafarzadeh Full name of responsible person - Persian: دکتر جعفر زاده Position - English: ACECR Infertility treatment center managment Position - Persian: مدیر مرکز درمان ناباروری جهاد دانشگاهی Latest degree: phd Area of specialty/work: 022 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: ACECR Infertility treatment center,Jame Jam AVE Street address - Persian: خیابان جام جم،مرکز درمان ناباروری جهاد دانشگاهی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5163963173 Phone: +98 41 3329 5730 Mobile: +98 914 107 5338 Fax: Email: s.jaafarzadesjafarzadeh@yahoo.comgmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: ACECR
Name of organization / entity - Persian: جهاددانشگاهی
Full name of responsible person - English: Dr Elaheh Baybordi
Full name of responsible person - Persian: دکتر الهه بایبوردی
Position - English: community medicine specialist
Position - Persian: متخصص پزشکی اجتماعی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: ACECR Infertility treatment center,Jaame jam Ave
Street address - Persian: مرکز درمان ناباروری جهاددانشگاهی
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3337 5188
Mobile: +98 914 412 3419
Fax:
Email: baybordi@acecr.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: ACECR
Name of organization / entity - Persian: جهاددانشگاهی
Full name of responsible person - English: Dr Elaheh Baybordi
Full name of responsible person - Persian: دکتر الهه بایبوردی
Position - English: assistant professor of community medicine
Position - Persian: استادیار پزشکی اجتماعی
Latest degree: specialist
Area of specialty/work: 29
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: ACECR Infertility treatment center,Jaame jam Ave
Street address - Persian: مرکز درمان ناباروری جهاددانشگاهی
City - English: تبریز
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5163963173
Phone: +98 41 3337 5188
Mobile: +98 914 412 3419
Fax:
Email: baybordi@acecr.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: ACECR Name of organization / entity - Persian: جهاددانشگاهی Full name of responsible person - English: Dr Elaheh Baybordi Full name of responsible person - Persian: دکتر الهه بایبوردی Position - English: assistant professor of community medicine specialist Position - Persian: متخصصاستادیار پزشکی اجتماعی Latest degree: specialist Area of specialty/work: 029 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: ACECR Infertility treatment center,Jaame jam Ave Street address - Persian: مرکز درمان ناباروری جهاددانشگاهی City - English: Tabrizتبریز City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5163963173 Phone: +98 41 3337 5188 Mobile: +98 914 412 3419 Fax: Email: baybordi@acecr.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: ACECR
Name of organization / entity - Persian: جهاددانشگاهی
Full name of responsible person - English: Dr Elaheh Baybordi
Full name of responsible person - Persian: دکتر الهه بایبوردی
Position - English: community medicine specialist
Position - Persian: متخصص پزشکی اجتماعی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: ACECR Infertility treatment center
Street address - Persian: مرکز درمان ناباروری جهاددانشگاهی
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3337 5188
Mobile: +98 914 412 3419
Fax:
Email: baybordi@acecr.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: ACECR
Name of organization / entity - Persian: جهاددانشگاهی
Full name of responsible person - English: Dr Elaheh Baybordi
Full name of responsible person - Persian: دکتر الهه بایبوردی
Position - English: community medicine specialist
Position - Persian: متخصص پزشکی اجتماعی
Latest degree: specialist
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: ACECR Infertility treatment center
Street address - Persian: مرکز درمان ناباروری جهاددانشگاهی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5163963173
Phone: +98 41 3337 5188
Mobile: +98 914 412 3419
Fax:
Email: baybordi@acecr.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: ACECR Name of organization / entity - Persian: جهاددانشگاهی Full name of responsible person - English: Dr Elaheh Baybordi Full name of responsible person - Persian: دکتر الهه بایبوردی Position - English: community medicine specialist Position - Persian: متخصص پزشکی اجتماعی Latest degree: specialist Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: ACECR Infertility treatment center Street address - Persian: مرکز درمان ناباروری جهاددانشگاهی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5163963173 Phone: +98 41 3337 5188 Mobile: +98 914 412 3419 Fax: Email: baybordi@acecr.ac.ir Web page address:
Sharing plan
undecided
undecided
yes
yes
yes
yes
yes
yes
yes
yes
undecided
undecided
undecided
undecided
empty
misuse
misuse
empty
سواستفاده افراد
سواستفاده افراد
empty
he completed questionnaire can be used
he completed questionnaire can be used
empty
پرسشنامه تکمیل شده میتواند مورد استفاده قرار گیرد
پرسشنامه تکمیل شده میتواند مورد استفاده قرار گیرد
empty
3 months after publication
3 months after publication
empty
3 ماه بعد از چاپ
3 ماه بعد از چاپ
empty
infertility researchers
infertility researchers
empty
محققین نازایی
محققین نازایی
empty
research
research
empty
محققان
محققان
empty
Elaheh Baybordi,
baybordi@acecr.ac.ir
Elaheh Baybordi, baybordi@acecr.ac.ir
empty
الهه بایبوردی
baybordi@acecr.ac.ir
الهه بایبوردی baybordi@acecr.ac.ir
empty
after receiving the email
after receiving the email
empty
بعد از دریافت ایمیل
بعد از دریافت ایمیل
Protocol summary
Study aim
determining the effect of platelet rich plasma on the improvement of pregnancy outcomes in repeated implantation failure
Design
A randomized; double-blind; controlled trial, with 118 cases in two intervention or control groups, parallel-group, phase 3, randomization with use of sealed envelopes.
Settings and conduct
Tabriz jihad daneshgahi ART center, Endometrial thickness is measured by trans vaginal ultrasound. In the intervention group, intrauterine injections of PRP are performed. PRP is prepared from autologous blood by centrifugation, and 0.5 to1 ml of PRP is injected into the uterine cavity. After 48 hours of PRP injection, the embryos are transferred to the uterine cavity in the blastocyst stage. In the control group, the standard treatment will done to transfer the embryo to the uterine cavity without intrauterine infusion of PRP.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women 18-45 years old; with a history of RIF during ART treatments. Exclusion criteria: pregnancy, diagnosed cancers, hemoglobin less than 11 gr per decilitre, platelets less than 150,000 per cc, use of anticoagulants, use of NSAID up to 10 days before the procedure, any physical or mental illness that affects the participant's immunity and admission.
Intervention groups
Intervention group: Intrauterine injection of autologous platelet rich plasma;
control group: standardized fertility treatment
Main outcome variables
Blood βHCG hormone; pregnancy sac and fetus heart rate in sonography
General information
Reason for update
data correction about sample size and IRCT update
Acronym
IRCT registration information
IRCT registration number:IRCT2017061434525N1
Registration date:2017-10-07, 1396/07/15
Registration timing:registered_while_recruiting
Last update:2022-03-07, 1400/12/16
Update count:2
Registration date
2017-10-07, 1396/07/15
Registrant information
Name
Elaheh Baybordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7924
Email address
baybordi@acecr.ac.ir
Recruitment status
Recruitment complete
Funding source
All costs are the responsibility of East Azarbaijan ACECR Organization.
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2018-02-01, 1396/11/12
Actual recruitment start date
2017-05-01, 1396/02/11
Actual recruitment end date
2018-02-01, 1396/11/12
Trial completion date
2018-02-01, 1396/11/12
Scientific title
Effect of autologous platelet-rich plasma on improving pregnancy outcomes in repeated implantation failure: A randomized controlled trial
Public title
Effect of autologous platelet-rich plasma on improving pregnancy outcomes in repeated implantation failure :A randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women of childbearing age (18-45 yrs)
A history of RIF (repeated implantation failure) during ART(Assisted reproductive technology ) treatments
Exclusion criteria:
pregnancy,
Diagnosed cancers,
Hemoglobin less than 11 gr per deciliter,
Patelets less than 150,000/ cc,
Use of anticoagulants,
Use of Non-steroidal anti-inflammatory drugs up to 10 days before the procedure,
Any physical or mental illness that affects the patient's immunity and admission and disrupts the process of project implementation and patient follow-up.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
118
Actual sample size reached:
94
Randomization (investigator's opinion)
Randomized
Randomization description
The method is simple randomization and using the tool of sealed envelopes. Participants select one of the envelopes and deliver it to the relevant observer. The letters A and B are written inside the envelope and the participants are divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of the assignment to the groups. The examining physician and sonographer are unaware of the assignment of the patient to the groups. The analyzer is only aware of groups A and B and is not aware of the control and intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Institute of Royanَ , ACECR
Street address
Hafez Alley,North Bani Hashem ST,Resalat High Way
City
Tehran
Province
Tehran
Postal code
148- 16635
Approval date
2017-08-15, 1396/05/24
Ethics committee reference number
IR.ACECR.ROYAN.REC.1396.183
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfer
Primary outcomes
1
Description
Positive pregnancy report with βHCG laboratory confirmed
Timepoint
4 weeks after intervention
Method of measurement
Measurement of βHCG hormone (mg / dl) by the Laboratory
2
Description
check the fetus heart rate ,
Timepoint
3 weeks after the check of positive HCG
Method of measurement
sonography
Secondary outcomes
1
Description
Intrauterine pregnancy diagnosis
Timepoint
4 weeks after intervention
Method of measurement
By ultrasound
Intervention groups
1
Description
intervention group: Injection of autologous platelet-rich plasma into the uterine cavity before embryos are transferred into the uterine cavity
Category
Treatment - Other
2
Description
Control group: the standard procedure and without autologous platelet-rich plasma injection, the embryos are transferred into the uterine cavity
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
East Azarbaijan ACECR infertility treatment center
Full name of responsible person
Dr Elaheh Baybordi
Street address
East Azarbaijan ACECR infertility treatment center, Jaam e Jam AVE
City
Tabriz
Province
East Azarbaijan
Postal code
5163963173
Phone
+98 41 3332 5730
Email
baybordi@acecr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Jafar Mohseni
Street address
ACECR Research center, Do Kamal Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163963173
Phone
+98 41 3658 8229
Email
baybordi@acecr.ac.ir
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
Public
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
ACECR
Full name of responsible person
Dr Jafarzadeh
Position
ACECR Infertility treatment center managment
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
ACECR Infertility treatment center,Jame Jam AVE
City
Tabriz
Province
East Azarbaijan
Postal code
5163963173
Phone
+98 41 3329 5730
Fax
Email
sjafarzadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ACECR
Full name of responsible person
Dr Elaheh Baybordi
Position
assistant professor of community medicine
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
ACECR Infertility treatment center,Jaame jam Ave
City
تبریز
Province
East Azarbaijan
Postal code
5163963173
Phone
+98 41 3337 5188
Fax
Email
baybordi@acecr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
ACECR
Full name of responsible person
Dr Elaheh Baybordi
Position
community medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Street address
ACECR Infertility treatment center
City
Tabriz
Province
East Azarbaijan
Postal code
5163963173
Phone
+98 41 3337 5188
Fax
Email
baybordi@acecr.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
he completed questionnaire can be used
When the data will become available and for how long
3 months after publication
To whom data/document is available
infertility researchers
Under which criteria data/document could be used
research
From where data/document is obtainable
Elaheh Baybordi,
baybordi@acecr.ac.ir
What processes are involved for a request to access data/document