The effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile patients: A randomized clinical trial
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Protocol summary
The aim of this study will be to investigate the value of intrauterine HCG injection before embryos transfer in improvement of implantation and pregnancy rates in cycles of
IVF/ ICSI. From April 2012 through March 2014 we will evaluated 159 patients undergoing IVF/ICSI at our center for treatment of infertility .
Patients will be divided into three groups using a random numbers table. In all patients in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Embryo transfer (ET) will be performed48-72 hours after. In the study groups, two groups of injecting HCG intrauterine, Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(1000 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS, 40 microliter of tissue culture medium containing 1000 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. In the control group, ET will performed without the intrauterine hCG injection.In control group between 2-3 embryo through of Cook catheter embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
primary outcomes: Chemical pregnancy, Clinical pregnancy , Implantation rates.
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The aim of this study will be to investigate the value of intrauterine HCG injection before embryos transfer in improvement of implantation and pregnancy rates in cycles of IVF/ ICSI. From April 2012 through March 2014 we will evaluated 159 patients undergoing IVF/ICSI at our center for treatment of infertility . Patients will be divided into three groups using a random numbers table. In all patients in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Embryo transfer (ET) will be performed48-72 hours after. In the study groups, two groups of injecting HCG intrauterine, Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(1000 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS, 40 microliter of tissue culture medium containing 1000 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. In the control group, ET will performed without the intrauterine hCG injection.In control group between 2-3 embryo through of Cook catheter embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used . primary outcomes: Chemical pregnancy, Clinical pregnancy , Implantation rates.
هدف از این مطالعه بررسی تاثیر تزریق HCG داخل رجمی قبل از انتقال جنین در بهبود میزان حاملگی و لانه گزینی در سیکل های IVF/ICSI می باشد. از فروردین 1391 تا اسفند 1392 ما تعداد159 بیماراز مراجعین به مرکز تحت IVF/ ICSI جهت درمان ناباروری را مورد بررسی قرار خواهیم داد.
بیماران با استفاده از جدول اعداد تصادفی به سه گروه تقسیم خواهند شد. در تمام بیماران در زمان مانیتورینگ زماني كه حداقل 3 فوليكول 18≤ ميليمتري در نماي سونوگرافي ديده شود ،10000 واحد HCG عضلاني تزريق خواهد شد . 36 ساعت بعد از پونكسيون اووسيت ،IVF یا ICSI انجام خواهد شد و 72-48 ساعت بعد انتقال جنین انجام خواهد شد . دردو گروه مورد مطالعه جهت تزریق HCG داخل رحمی, محیط کشت به یک ویال HCG 5000واحد، اضافه شده و رقت های مورد نیاز بدست خواهد آمد. در روز دوم یا سوم بعد از برداشت اووسیت، بعداز گذاشتن اسپکولوم و مشاهده سرویکس در وضعیت لیتوتومی ،انتقال جنین از طریق یک کاتتر نرم ( Cook) انجام خوا هد شد. بعد از عبور از مجرای داخلی سرویکس, مقدار 40 میکرولیتر از محیط کشت آماده شده متشکل از 500 واحد یا 1000 واحد HCG قبل از انتقال جنین به صورت داخل رحمی تزریق خواهد شد.بعد از گذشت حدود هفت دقیقه بین 3-2 جنین از طریق کاتتر دیگری ( cook) منتقل خواهد شد . در گروه کنترل بین 3-2 جنین از طریق کاتتر ( Cook) بدون تزریق داخل رحمی HCG منتقل خواهد شد.براي ساپورت فاز لوتئال از پروژسترون تزريقي 100 ميليگرم عضلاني استفاده خواهد شد.
پیامد های اولیه: حاملگی شیمیایی ،حاملگی کلینیکی ،میزان لانه گزینی
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هدف از این مطالعه بررسی تاثیر تزریق HCG داخل رجمی قبل از انتقال جنین در بهبود میزان حاملگی و لانه گزینی در سیکل های IVF/ICSI می باشد. از فروردین 1391 تا اسفند 1392 ما تعداد159 بیماراز مراجعین به مرکز تحت IVF/ ICSI جهت درمان ناباروری را مورد بررسی قرار خواهیم داد. بیماران با استفاده از جدول اعداد تصادفی به سه گروه تقسیم خواهند شد. در تمام بیماران در زمان مانیتورینگ زماني كه حداقل 3 فوليكول 18≤ ميليمتري در نماي سونوگرافي ديده شود ،10000 واحد HCG عضلاني تزريق خواهد شد . 36 ساعت بعد از پونكسيون اووسيت ،IVF یا ICSI انجام خواهد شد و 72-48 ساعت بعد انتقال جنین انجام خواهد شد . دردو گروه مورد مطالعه جهت تزریق HCG داخل رحمی, محیط کشت به یک ویال HCG 5000واحد، اضافه شده و رقت های مورد نیاز بدست خواهد آمد. در روز دوم یا سوم بعد از برداشت اووسیت، بعداز گذاشتن اسپکولوم و مشاهده سرویکس در وضعیت لیتوتومی ،انتقال جنین از طریق یک کاتتر نرم ( Cook) انجام خوا هد شد. بعد از عبور از مجرای داخلی سرویکس, مقدار 40 میکرولیتر از محیط کشت آماده شده متشکل از 500 واحد یا 1000 واحد HCG قبل از انتقال جنین به صورت داخل رحمی تزریق خواهد شد.بعد از گذشت حدود هفت دقیقه بین 3-2 جنین از طریق کاتتر دیگری ( cook) منتقل خواهد شد . در گروه کنترل بین 3-2 جنین از طریق کاتتر ( Cook) بدون تزریق داخل رحمی HCG منتقل خواهد شد.براي ساپورت فاز لوتئال از پروژسترون تزريقي 100 ميليگرم عضلاني استفاده خواهد شد. پیامد های اولیه: حاملگی شیمیایی ،حاملگی کلینیکی ،میزان لانه گزینی
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This study aims to investigate the effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile women.
This study aims to investigate the effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile women.
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هدف از این مطالعه بررسی تاثیر تزریق گونادوتروپین کوریونی انسانی داخل رحمی قبل از انتقال جنین در میزان حاملگی و لانه گزینی در زنان نابارور می باشد.
هدف از این مطالعه بررسی تاثیر تزریق گونادوتروپین کوریونی انسانی داخل رحمی قبل از انتقال جنین در میزان حاملگی و لانه گزینی در زنان نابارور می باشد.
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Clinical trial with control group, parallel, phase 2 on 159 patients (n=53/each group), random number table was used for randomization.
Clinical trial with control group, parallel, phase 2 on 159 patients (n=53/each group), random number table was used for randomization.
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کارآزمایی بالینی دارای با گروه کنترل، موازی، تصادفی شده، فاز 2 بر روی 159بیمار(3 گروه 53 نفره)، برای تصادفی سازی از جدول اعداد تصادفی استفاده شد.
کارآزمایی بالینی دارای با گروه کنترل، موازی، تصادفی شده، فاز 2 بر روی 159بیمار(3 گروه 53 نفره)، برای تصادفی سازی از جدول اعداد تصادفی استفاده شد.
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159 participants undergoing In vitro Fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI) with an antagonist protocol referring to Yazd Research and Clinical Center for infertility will be evaluated from April 2012 to March 2013 will be evaluated. Patients will be divided into 3 groups (n=53) by using computer-generated random numbers. Randomization was simple, individual using a random number table and the ratio of 1:1. In this study, Blinding was not done.
159 participants undergoing In vitro Fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI) with an antagonist protocol referring to Yazd Research and Clinical Center for infertility will be evaluated from April 2012 to March 2013 will be evaluated. Patients will be divided into 3 groups (n=53) by using computer-generated random numbers. Randomization was simple, individual using a random number table and the ratio of 1:1. In this study, Blinding was not done.
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159 شرکت کننده تحت لقاح آزمایشگاهی/ تزریق داخل سیتوپلاسمی اسپرم با پروتکل آنتاگونیست مراجعه کننده به مرکز تحقیقات ناباروری یزد از فروردین 1391 تا اسفند 1392 مورد ارزیابی قرار خواهند گرفت. بیماران با استفاده از اعداد تصادفی تولید شده توسط کامپیوتر به 3 گروه (n=53) تقسیم خواهند شد. تصادفی سازی ساده، فردی با استفاده از جدول اعداد تصادفی و نسبت 1:1 بود. در این مطالعه کورسازی انجام نخواهد شد.
159 شرکت کننده تحت لقاح آزمایشگاهی/ تزریق داخل سیتوپلاسمی اسپرم با پروتکل آنتاگونیست مراجعه کننده به مرکز تحقیقات ناباروری یزد از فروردین 1391 تا اسفند 1392 مورد ارزیابی قرار خواهند گرفت. بیماران با استفاده از اعداد تصادفی تولید شده توسط کامپیوتر به 3 گروه (n=53) تقسیم خواهند شد. تصادفی سازی ساده، فردی با استفاده از جدول اعداد تصادفی و نسبت 1:1 بود. در این مطالعه کورسازی انجام نخواهد شد.
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Inclusion criteria: Women aged 20-40 years with male factor or unexplained infertility and basal FSH less than 12.
Inclusion criteria: Women aged 20-40 years with male factor or unexplained infertility and basal FSH less than 12.
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شرایط ورود: زنان با سن 40-20 سال با عامل مردانه یا ناباروری با عامل نا مشخص و FSH پایه کمتر از 12.
شرایط ورود: زنان با سن 40-20 سال با عامل مردانه یا ناباروری با عامل نا مشخص و FSH پایه کمتر از 12.
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Group 1 will receive 500 IU of human chorionic gonadotropin (hCG), group 2 will receive 1000 IU of hCG intrauterine injection before embryo transfer, and the control group will undergo embryo transfer (2-3 embryos) without hCG preceding intrauterine injection. Approximately 7 minutes after intrauterine HCG injection, 2-3 embryos will be transferred via another soft catheter (Cook). For luteal phase support, intramuscular injection of 100 mg progesterone will be used.
Group 1 will receive 500 IU of human chorionic gonadotropin (hCG), group 2 will receive 1000 IU of hCG intrauterine injection before embryo transfer, and the control group will undergo embryo transfer (2-3 embryos) without hCG preceding intrauterine injection. Approximately 7 minutes after intrauterine HCG injection, 2-3 embryos will be transferred via another soft catheter (Cook). For luteal phase support, intramuscular injection of 100 mg progesterone will be used.
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گروه یک تحت تزریق 500 واحد گنادوتروپین جفتی انسانی(hCG) داخل رحمی، گروه دو تحت تزریق 1000 واحد hCG داخل رحمی قبل از انتقال جنین و گروه کنترل بدون تزریق داخل رحمی hCG قبل از انتقال جنین قرار خواهند گرفت. بعد از گذشت حدود هفت دقیقه بین 3-2 جنین از طریق کاتتر دیگری ( cook) منتقل خواهد شد. در گروه کنترل بین 3-2 جنین از طریق کاتتر ( Cook) بدون تزریق داخل رحمی HCG منتقل خواهد شد. براي ساپورت فاز لوتئال از پروژسترون تزريقي 100 ميليگرم عضلاني استفاده خواهد شد.
گروه یک تحت تزریق 500 واحد گنادوتروپین جفتی انسانی(hCG) داخل رحمی، گروه دو تحت تزریق 1000 واحد hCG داخل رحمی قبل از انتقال جنین و گروه کنترل بدون تزریق داخل رحمی hCG قبل از انتقال جنین قرار خواهند گرفت. بعد از گذشت حدود هفت دقیقه بین 3-2 جنین از طریق کاتتر دیگری ( cook) منتقل خواهد شد. در گروه کنترل بین 3-2 جنین از طریق کاتتر ( Cook) بدون تزریق داخل رحمی HCG منتقل خواهد شد. براي ساپورت فاز لوتئال از پروژسترون تزريقي 100 ميليگرم عضلاني استفاده خواهد شد.
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primary outcomes: Chemical and Clinical pregnancy rates, Implantation rate. secondary outcome: abortion rate
primary outcomes: Chemical and Clinical pregnancy rates, Implantation rate. secondary outcome: abortion rate
Updating the date of sampling and the end of the clinical trial and things such as the exact mention of randomization, inclusion/exclusion criteria and study outcomes.
Updating the date of sampling and the end of the clinical trial and things such as the exact mention of randomization, inclusion/exclusion criteria and study outcomes.
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بروزرسانی تاریخ نمونه گیری و پایان کارآزمایی بالینی و مواردی مانند ذکر دقیق نحوه تصادفی سازی، معیار های ورود و خروج و پیامد های مطالعه.
بروزرسانی تاریخ نمونه گیری و پایان کارآزمایی بالینی و مواردی مانند ذکر دقیق نحوه تصادفی سازی، معیار های ورود و خروج و پیامد های مطالعه.
Evaluation effect of human chorionic gonadotropin on pregnancy outcome in infertile patients
The effect of intrauterine human chorionic gonadotropin injection on pregnancy outcomes in infertile patients
EvaluationThe effect of intrauterine human chorionic gonadotropin injection on pregnancy outcomeoutcomes in infertile patients
بررسی اثر هورمون جفتی انسانی بر نتایج حاملگی در بیماران نابارور
تاثیر تزریق داخل رحمی هورمون جفتی انسانی بر نتایج حاملگی در بیماران نابارور
بررسی اثرتاثیر تزریق داخل رحمی هورمون جفتی انسانی بر نتایج حاملگی در بیماران نابارور
Evaluation effect of intrauterine human chorionic gonadotropin injection before embryo transfer in implantation and pregnancy rate in infertile patients and comparison with conventional embryo transfer in IVF/ICSI/ET cycles
The effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile patients: A randomized clinical trial
EvaluationThe effect of intrauterine human chorionic gonadotropin injection before embryo transfer inon the implantation and pregnancy rate in infertile patients and comparison with conventional embryo transfer in IVF/ICSI/ET cycles: A randomized clinical trial
بررسی تاثیر تزریق داخل رحمی HCG قبل از انتقال جنین در میزان لانه گزینی وحاملگی در بیماران نابارور و مقایسه آن با روش مرسوم انتقال جنین در سیکل های IVF/ICSI/ET
تاثیر تزریق داخل رحمی HCG قبل از انتقال جنین بر میزان لانه گزینی و حاملگی در بیماران نابارور : یک کار آزمایی بالینی تصادفی
بررسی تاثیر تزریق داخل رحمی HCG قبل از انتقال جنین دربر میزان لانه گزینی وحاملگیو حاملگی در بیماران نابارور و مقایسه آن با روش مرسوم انتقال جنین در سیکل های IVF/ICSI/ET: یک کار آزمایی بالینی تصادفی
female
age in the range of 20-40 years
male factor infertility
unexplained infertility
basal FSH less than 12.
female age in the range of 20-40 years male factor infertility unexplained infertility basal FSH less than 12.
زن
20 تا 40 سال
ناباروری با عامل مردانه
ناباروری با علت نامشخص
FSH پایه کمتر از 12
زن 20 تا 40 سال ناباروری با عامل مردانه ناباروری با علت نامشخص FSH پایه کمتر از 12
azoospermia,
presence of uterine myoma
endometriosis
hydrosalpinges
previous IVF/ICSI trials (successful or unsuccessful)
history of endocrine diseases such as diabetes and thyroid dysfunction
previous history of hysterocopic operation due to submoucosal myoma, and intrauterine synechia.
azoospermia, presence of uterine myoma endometriosis hydrosalpinges previous IVF/ICSI trials (successful or unsuccessful) history of endocrine diseases such as diabetes and thyroid dysfunction previous history of hysterocopic operation due to submoucosal myoma, and intrauterine synechia.
آزوسپرمی
وجود میوم رحمی
اندومتریوز
هیدروسالپینکس
سابقه هر گونه IVF قبلی(موفق یا نا موفق)
سابقه بیماری های اندوکرین مثل دیابت یا اختلالات تیروئید
بیمارانی که به علت ضایعات داخل رحمی مثل میوم ساب موکوز یا چسپندگیهای داخل رحمی تحت عمل جراحی با هیستروسکوپ قرار گرفته اند.
آزوسپرمی وجود میوم رحمی اندومتریوز هیدروسالپینکس سابقه هر گونه IVF قبلی(موفق یا نا موفق) سابقه بیماری های اندوکرین مثل دیابت یا اختلالات تیروئید بیمارانی که به علت ضایعات داخل رحمی مثل میوم ساب موکوز یا چسپندگیهای داخل رحمی تحت عمل جراحی با هیستروسکوپ قرار گرفته اند.
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Women who met the inclusion criteria were numbered from 1 to 159 in order of referral. After being explained about the study method and obtaining informed consent two columns of 53 random numbers from 1-159 were produced using statistical soft version Minitab 14 software (Minitab. LLC, 2014. Minitab, Available at: http://www.minitab.com); numbers that were not in these columns were considered as third group. Each lists was randomly assigned to one of the intervention groups A, B and C (control). The simple randomization method was used. Envelopes and codes were assigned for all participants. Group one was marked with A, group two with B and group three with C. A code has been assigned to each envelope and this code was recorded for each participant.
Women who met the inclusion criteria were numbered from 1 to 159 in order of referral. After being explained about the study method and obtaining informed consent two columns of 53 random numbers from 1-159 were produced using statistical soft version Minitab 14 software (Minitab. LLC, 2014. Minitab, Available at: http://www.minitab.com); numbers that were not in these columns were considered as third group. Each lists was randomly assigned to one of the intervention groups A, B and C (control). The simple randomization method was used. Envelopes and codes were assigned for all participants. Group one was marked with A, group two with B and group three with C. A code has been assigned to each envelope and this code was recorded for each participant.
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زنانی که معیارهای ورود به مطالعه را دارا بودند از شماره 1 تا 159 به ترتیب مراجعه شماره گذاری شدند. پس از توجیه شدن در مورد روش مطالعه و اخذ رضایت آگاهانه با استفاده از نرم افزارstatistical soft version 14 (Minitab. LLC, 2014. Minitab, Available at: http://www.minitab.com) Minitab دو ستون 53 تایی اعداد تصادفی از بین 1 تا 159 تولید شده و اعدادی که در این ستون نبودند به عنوان نمونه های گروه سوم در نظر گرفته شد. هر کدام از این سه لیست اعداد تصادفی به تصادف به یکی از گروه های مداخله A،B و C (کنترل) تخصیص داده شدند. روش تصادفی سازی نمونه ها در گروه ها به صورت Simple Randomization بوده است. به منظور پنهان سازی به تعداد کل بیماران پاکت و کد تهیه می شود. در هر پاکت گروه یک با A، گروه دو با B و گروه سه با C مشخص شده است. روی هر پاکت یک کد تخصیص داده شده است. کد پاکت ها برای هر بیمار ثبت می شود.
زنانی که معیارهای ورود به مطالعه را دارا بودند از شماره 1 تا 159 به ترتیب مراجعه شماره گذاری شدند. پس از توجیه شدن در مورد روش مطالعه و اخذ رضایت آگاهانه با استفاده از نرم افزارstatistical soft version 14 (Minitab. LLC, 2014. Minitab, Available at: http://www.minitab.com) Minitab دو ستون 53 تایی اعداد تصادفی از بین 1 تا 159 تولید شده و اعدادی که در این ستون نبودند به عنوان نمونه های گروه سوم در نظر گرفته شد. هر کدام از این سه لیست اعداد تصادفی به تصادف به یکی از گروه های مداخله A،B و C (کنترل) تخصیص داده شدند. روش تصادفی سازی نمونه ها در گروه ها به صورت Simple Randomization بوده است. به منظور پنهان سازی به تعداد کل بیماران پاکت و کد تهیه می شود. در هر پاکت گروه یک با A، گروه دو با B و گروه سه با C مشخص شده است. روی هر پاکت یک کد تخصیص داده شده است. کد پاکت ها برای هر بیمار ثبت می شود.
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Primary outcomes
#1
4 weeks after embryo transfer
Identified through vaginal or abdominal ultrasound 4-5 wks after the embryo transfer.
Identified through vaginal or abdominal ultrasound 4 weeks-5 wks after the embryo transfer.
چهار هفته بعد از انتقال جنین
از طریق سونوگرافی واژینال یا شکمی 4-5 هفته پس از انتقال جنین شناسایی می شود.
چهاراز طریق سونوگرافی واژینال یا شکمی 4-5 هفته بعدپس از انتقال جنین شناسایی می شود.
#2
observation of fetal heart activity by transvaginal ultrasonography
observation of fetal heart activity by trans vaginal or abdominal ultrasound
observation of fetal heart activity by transvaginal ultrasonographytrans vaginal or abdominal ultrasound
مشاهده ضربان قلب جنين بوسيله سونوگرافي واژینال
مشاهده ضربان قلب جنين توسط سونوگرافي ترانس واژینال یا شکمی
مشاهده ضربان قلب جنين بوسيلهتوسط سونوگرافي ترانس واژینال یا شکمی
Secondary outcomes
#1
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Abortion
Abortion
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سقط
سقط
empty
Before the 20th week of pregnancy
Before the 20th week of pregnancy
empty
قبل از هفته 20 بارداری
قبل از هفته 20 بارداری
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Abortion product observation (placenta and fetus residual)
Abortion product observation (placenta and fetus residual)
empty
مشاهده ی محصولات سقط (بقایای جفت و جنین)
مشاهده ی محصولات سقط (بقایای جفت و جنین)
Recruitment centers
#1
Name of recruitment center - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science ,Yazd
Name of recruitment center - Persian: مركز تحقيقاتي درماني ناباروري, دانشگاه علوم پزشكي شهيد صدوقي يزد
Full name of responsible person - English: Dr.Sima Janati
Full name of responsible person - Persian: دکتر سیما جنتی
Street address - English: Boali Ave, Safayeh , Research and Clinical Center for Infertility,Yazd
Street address - Persian: یزد، صفائيه، خیابان بوعلی ، مرکزتحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science ,Yazd
Name of recruitment center - Persian: مركز تحقيقاتي درماني ناباروري, دانشگاه علوم پزشكي شهيد صدوقي يزد
Full name of responsible person - English: Dr.Sima Janati
Full name of responsible person - Persian: دکتر سیما جنتی
Street address - English: Boali Ave, Safayeh , Research and Clinical Center for Infertility,Yazd
Street address - Persian: یزد، صفائيه، خیابان بوعلی ، مرکزتحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۸۷۷۳۹۱
Phone: +98 35 3824 7085
Fax:
Email: yazd-rsi@ssu.ac.ir
Web page address:
Name of recruitment center - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science ,Yazd Name of recruitment center - Persian: مركز تحقيقاتي درماني ناباروري, دانشگاه علوم پزشكي شهيد صدوقي يزد Full name of responsible person - English: Dr.Sima Janati Full name of responsible person - Persian: دکتر سیما جنتی Street address - English: Boali Ave, Safayeh , Research and Clinical Center for Infertility,Yazd Street address - Persian: یزد، صفائيه، خیابان بوعلی ، مرکزتحقیقاتی و درمانی ناباروری City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: ۸۹۱۶۸۷۷۳۹۱ Phone: +98 35 3824 7085 Fax: Email: yazd-rsi@ssu.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente
Name of organization / entity - Persian: معاونت پژو هشی دانشگاه علوم پزشکی شهید صدوقی یزد، مرکزتحقیقاتی و درمانی ناباروری
Full name of responsible person - English: Dr. Razieh Dehghani Firouzabadi
Full name of responsible person - Persian: دکتر راضیه دهقانی فیروز آبادی
Street address - English: Bouali Ave,Safayeh, Research and Clinical Center for Infertility, Yazd
Street address - Persian: یزد، صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente
Name of organization / entity - Persian: معاونت پژو هشی دانشگاه علوم پزشکی شهید صدوقی یزد، مرکزتحقیقاتی و درمانی ناباروری
Full name of responsible person - English: Dr. Razieh Dehghani Firouzabadi
Full name of responsible person - Persian: دکتر راضیه دهقانی فیروز آبادی
Street address - English: Bouali Ave,Safayeh, Research and Clinical Center for Infertility, Yazd
Street address - Persian: یزد، صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۸۷۷۳۹۱
Phone: +98 35 3824 7085
Fax:
Email: yazd-rsi@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente Name of organization / entity - Persian: معاونت پژو هشی دانشگاه علوم پزشکی شهید صدوقی یزد، مرکزتحقیقاتی و درمانی ناباروری Full name of responsible person - English: Dr. Razieh Dehghani Firouzabadi Full name of responsible person - Persian: دکتر راضیه دهقانی فیروز آبادی Street address - English: Bouali Ave,Safayeh, Research and Clinical Center for Infertility, Yazd Street address - Persian: یزد، صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: ۸۹۱۶۸۷۷۳۹۱ Phone: +98 35 3824 7085 Fax: Email: yazd-rsi@ssu.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Name of organization / entity - Persian: مركز تحقيقاتي ودرماني ناباروري، دانشگاه علوم پزشكي شهيد صدوقي يزد
Full name of responsible person - English: Dr.Sima Janati
Full name of responsible person - Persian: دکتر سیما جنتی
Position - English: Assisted Professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Position - Persian: استاد یار زنان، فلو شیپ نازایی در حال تحصیل
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Yazd
Street address - Persian: یزد، صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 35 1824 7085
Mobile: +98 916 140 7211
Fax: +98 35 1824 7087
Email: janati@dums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Name of organization / entity - Persian: مركز تحقيقاتي ودرماني ناباروري، دانشگاه علوم پزشكي شهيد صدوقي يزد
Full name of responsible person - English: Dr.Sima Janati
Full name of responsible person - Persian: دکتر سیما جنتی
Position - English: Assisted Professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Position - Persian: استاد یار زنان، فلو شیپ نازایی در حال تحصیل
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Research and Clinical Center for Infertility, Bouali Ave, Safayeh,Yazd
Street address - Persian: یزد، صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۸۷۷۳۹۱
Phone: +98 35 1824 7085
Mobile: +98 916 140 7211
Fax: +98 35 1824 7087
Email: janati@dums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd Name of organization / entity - Persian: مركز تحقيقاتي ودرماني ناباروري، دانشگاه علوم پزشكي شهيد صدوقي يزد Full name of responsible person - English: Dr.Sima Janati Full name of responsible person - Persian: دکتر سیما جنتی Position - English: Assisted Professor of Obstetrics and Gynecology, fellowship of infertility in state of training Position - Persian: استاد یار زنان، فلو شیپ نازایی در حال تحصیل Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Bouali Ave, Safayeh, Research and Clinical Center for Infertility, YazdBouali Ave, Safayeh,Yazd Street address - Persian: یزد، صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری City - English: Yazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۸۹۱۶۸۷۷۳۹۱ Phone: +98 35 1824 7085 Mobile: +98 916 140 7211 Fax: +98 35 1824 7087 Email: janati@dums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd
Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی يزد
Full name of responsible person - English: Dr.Razieh Dehghani Firouzabadi
Full name of responsible person - Persian: دکتر راضیه دهقانی فیروز آبادی
Position - English: Associate professor of Obstetrics and Gynecology, fellow ship of infertility
Position - Persian: دانشیار زنان، فلو شیپ نازایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bouali Ave, Safayeh، Research and Clinical Center for Infertility, Yazd
Street address - Persian: یزد، صفائيه، خیابان بوعلی، مركز تحقيقاتي و درماني ناباروري
City - English: Yazd
City - Persian: یزد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 35 1824 7085
Mobile: +98 913 151 4236
Fax: +98 35 1824 7087
Email: dr-firouzabadi@ssu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd
Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی يزد
Full name of responsible person - English: Dr.Razieh Dehghani Firouzabadi
Full name of responsible person - Persian: دکتر راضیه دهقانی فیروز آبادی
Position - English: Associate professor of Obstetrics and Gynecology, fellow ship of infertility
Position - Persian: دانشیار زنان، فلو شیپ نازایی
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Research and Clinical Center for Infertility, Bouali Ave, Safayeh، Yazd
Street address - Persian: یزد، صفائيه، خیابان بوعلی، مركز تحقيقاتي و درماني ناباروري
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۸۷۷۳۹۱
Phone: +98 35 1824 7085
Mobile: 098 913 151 4236
Fax: +98 35 1824 7087
Email: dr-firouzabadi@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی يزد Full name of responsible person - English: Dr.Razieh Dehghani Firouzabadi Full name of responsible person - Persian: دکتر راضیه دهقانی فیروز آبادی Position - English: Associate professor of Obstetrics and Gynecology, fellow ship of infertility Position - Persian: دانشیار زنان، فلو شیپ نازایی Latest degree: sub_specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Bouali Ave, Safayeh، Research and Clinical Center for Infertility, Bouali Ave, Safayeh، Yazd Street address - Persian: یزد، صفائيه، خیابان بوعلی، مركز تحقيقاتي و درماني ناباروري City - English: Yazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۸۹۱۶۸۷۷۳۹۱ Phone: +98 35 1824 7085 Mobile: +98098 913 151 4236 Fax: +98 35 1824 7087 Email: dr-firouzabadi@ssu.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr. Sima Janati
Full name of responsible person - Persian: دکتر سیما جنتی
Position - English: Assisted professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Position - Persian: استادیار زنان، فلوشیپ نازایی در حال تحصیل
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Yazd
Street address - Persian: يزد، صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 35 1824 7085
Mobile: +98 916 140 7211
Fax: +98 35 1824 7087
Email: janati@dums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr. Sima Janati
Full name of responsible person - Persian: دکتر سیما جنتی
Position - English: Assisted professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Position - Persian: استادیار زنان، فلوشیپ نازایی در حال تحصیل
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Research and Clinical Center for Infertility, Bouali Ave, Safayeh, Yazd
Street address - Persian: يزد، صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۸۷۷۳۹۱
Phone: +98 35 1824 7085
Mobile: +98 916 140 7211
Fax: +98 35 1824 7087
Email: janati@dums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد Full name of responsible person - English: Dr. Sima Janati Full name of responsible person - Persian: دکتر سیما جنتی Position - English: Assisted professor of Obstetrics and Gynecology, fellowship of infertility in state of training Position - Persian: استادیار زنان، فلوشیپ نازایی در حال تحصیل Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Bouali Ave, Safayeh, Yazd Street address - Persian: يزد، صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی ناباروری City - English: Yazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۸۹۱۶۸۷۷۳۹۱ Phone: +98 35 1824 7085 Mobile: +98 916 140 7211 Fax: +98 35 1824 7087 Email: janati@dums.ac.ir Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
empty
All participant data sets are to be shared
All participant data sets are to be shared
empty
کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
empty
2 months after the result publication
2 months after the result publication
empty
2 ماه بعد از چاپ نتایج
2 ماه بعد از چاپ نتایج
empty
Researchers working in academic and scientific institutes, Journal editors and Reviewers
Researchers working in academic and scientific institutes, Journal editors and Reviewers
empty
محققین شاغل در موسسات دانشگاهی و علمی، مسئول مجله و داوران
محققین شاغل در موسسات دانشگاهی و علمی، مسئول مجله و داوران
empty
Submission of an official application via the agent that is legally in charge
Submission of an official application via the agent that is legally in charge
empty
درخواست رسمی از طریق مرجع قانونی
درخواست رسمی از طریق مرجع قانونی
empty
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085
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پژوهشکده علوم تولید مثل یزد، خیابان بوعلی، یزد، ایران. 983538247085
پژوهشکده علوم تولید مثل یزد، خیابان بوعلی، یزد، ایران. 983538247085
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Immediately after the Submission of an official application via the agent that is legally in charge (About a month) by sending an email to janati@dums.ac.ir.
Immediately after the Submission of an official application via the agent that is legally in charge (About a month) by sending an email to janati@dums.ac.ir.
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بلافاصله بعد از درخواست رسمی از طریق مرجع قانونی (حدود یک ماه) با ارسال ایمیل به janati@dums.ac.ir.
بلافاصله بعد از درخواست رسمی از طریق مرجع قانونی (حدود یک ماه) با ارسال ایمیل به janati@dums.ac.ir.
Protocol summary
Study aim
This study aims to investigate the effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile women.
Design
Clinical trial with control group, parallel, phase 2 on 159 patients (n=53/each group), random number table was used for randomization.
Settings and conduct
159 participants undergoing In vitro Fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI) with an antagonist protocol referring to Yazd Research and Clinical Center for infertility will be evaluated from April 2012 to March 2013 will be evaluated. Patients will be divided into 3 groups (n=53) by using computer-generated random numbers. Randomization was simple, individual using a random number table and the ratio of 1:1. In this study, Blinding was not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 20-40 years with male factor or unexplained infertility and basal FSH less than 12.
Intervention groups
Group 1 will receive 500 IU of human chorionic gonadotropin (hCG), group 2 will receive 1000 IU of hCG intrauterine injection before embryo transfer, and the control group will undergo embryo transfer (2-3 embryos) without hCG preceding intrauterine injection. Approximately 7 minutes after intrauterine HCG injection, 2-3 embryos will be transferred via another soft catheter (Cook). For luteal phase support, intramuscular injection of 100 mg progesterone will be used.
Main outcome variables
primary outcomes: Chemical and Clinical pregnancy rates, Implantation rate. secondary outcome: abortion rate
General information
Reason for update
Updating the date of sampling and the end of the clinical trial and things such as the exact mention of randomization, inclusion/exclusion criteria and study outcomes.
Acronym
IRCT registration information
IRCT registration number:IRCT2012091310328N3
Registration date:2013-01-12, 1391/10/23
Registration timing:registered_while_recruiting
Last update:2022-11-07, 1401/08/16
Update count:2
Registration date
2013-01-12, 1391/10/23
Registrant information
Name
Sima Janati
Name of organization / entity
Research and Clinical Center for Infertility, Dezful University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 9781
Email address
janati@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Clinical Center for Infertility, Shahid sadoughi university of medical sciences, Yazd
Expected recruitment start date
2012-04-05, 1391/01/17
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
2012-04-05, 1391/01/17
Actual recruitment end date
2013-03-19, 1391/12/29
Trial completion date
2013-09-20, 1392/06/29
Scientific title
The effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile patients: A randomized clinical trial
Public title
The effect of intrauterine human chorionic gonadotropin injection on pregnancy outcomes in infertile patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female
age in the range of 20-40 years
male factor infertility
unexplained infertility
basal FSH less than 12.
Exclusion criteria:
azoospermia,
presence of uterine myoma
endometriosis
hydrosalpinges
previous IVF/ICSI trials (successful or unsuccessful)
history of endocrine diseases such as diabetes and thyroid dysfunction
previous history of hysterocopic operation due to submoucosal myoma, and intrauterine synechia.
Age
From 20 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
159
Actual sample size reached:
159
Randomization (investigator's opinion)
Randomized
Randomization description
Women who met the inclusion criteria were numbered from 1 to 159 in order of referral. After being explained about the study method and obtaining informed consent two columns of 53 random numbers from 1-159 were produced using statistical soft version Minitab 14 software (Minitab. LLC, 2014. Minitab, Available at: http://www.minitab.com); numbers that were not in these columns were considered as third group. Each lists was randomly assigned to one of the intervention groups A, B and C (control). The simple randomization method was used. Envelopes and codes were assigned for all participants. Group one was marked with A, group two with B and group three with C. A code has been assigned to each envelope and this code was recorded for each participant.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd
Street address
Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Approval date
2012-03-15, 1390/12/25
Ethics committee reference number
3771
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 transfe
Primary outcomes
1
Description
Implantation rate
Timepoint
Identified through vaginal or abdominal ultrasound 4-5 wks after the embryo transfer.
Method of measurement
Observation of number of gestational sacs by transvaginal ultrasonography per 100 embryo transfer
2
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
BHCG test
3
Description
Clinical pregnancy
Timepoint
4 -5 weeks after embryo transfer
Method of measurement
observation of fetal heart activity by trans vaginal or abdominal ultrasound
Secondary outcomes
1
Description
Abortion
Timepoint
Before the 20th week of pregnancy
Method of measurement
Abortion product observation (placenta and fetus residual)
Intervention groups
1
Description
In control group (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed and 48-72 hours after between 2-3 embryo through of Cook catheter embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
Category
Treatment - Drugs
2
Description
In group 1 intervention (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(500 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS , 40 microliter of tissue culture medium containing 500 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
Category
Treatment - Drugs
3
Description
In group 2 intervention (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(1000 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS, 40 microliter of tissue culture medium containing 1000 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science ,Yazd
Full name of responsible person
Dr.Sima Janati
Street address
Boali Ave, Safayeh , Research and Clinical Center for Infertility,Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
yazd-rsi@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente
Full name of responsible person
Dr. Razieh Dehghani Firouzabadi
Street address
Bouali Ave,Safayeh, Research and Clinical Center for Infertility, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
yazd-rsi@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente
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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Full name of responsible person
Dr.Sima Janati
Position
Assisted Professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh,Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
janati@dums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd
Full name of responsible person
Dr.Razieh Dehghani Firouzabadi
Position
Associate professor of Obstetrics and Gynecology, fellow ship of infertility
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh، Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
dr-firouzabadi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Full name of responsible person
Dr. Sima Janati
Position
Assisted professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
janati@dums.ac.ir
Web page address
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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participant data sets are to be shared
When the data will become available and for how long
2 months after the result publication
To whom data/document is available
Researchers working in academic and scientific institutes, Journal editors and Reviewers
Under which criteria data/document could be used
Submission of an official application via the agent that is legally in charge
From where data/document is obtainable
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085
What processes are involved for a request to access data/document
Immediately after the Submission of an official application via the agent that is legally in charge (About a month) by sending an email to janati@dums.ac.ir.