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The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure: A multicenter clinical randomized study.

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History
# Registration date Revision Id
2 2021-06-30, 1400/04/09 194903
1 2020-12-21, 1399/10/01 163963
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  • Protocol summary

    To evaluate the effect of the growth hormone on the uterine respectivity of the patients with recurrent implantation failure Qualitative evaluation of the uterus after the intervention by help of vaginal sonography, two- dimensional and three-dimensional Doppler vaginal ultrasound
    To evaluate the effect of the growth hormone on the pregnancy outcomes of the patients with unexplained recurrent implantation failure Qualitative evaluation of the uterus after the intervention by help of vaginal sonography, two- dimensional and three-dimensional Doppler vaginal ultrasound
    بررسی اثر هورمون رشد در پذیرش رحمی بیماران با شکست مکرر لانه گزینی ارزیابی کیفی رحم بعد از پایان مداخله از لانه گزینی باکمک سونوگرافی واژینال وداپلر دوبعدی وسه بعدی
    بررسی اثر هورمون رشد در نتایج حاملگی شکست مکرر لانه گزینی ارزیابی کیفی رحم بعد از پایان مداخله از لانه گزینی باکمک سونوگرافی واژینال وداپلر دوبعدی وسه بعدی
    single-blind randomized two-arm clinical trial study in two groups of growth hormone-receiving and non-growth-hormone patients in patients with recurrent implantation failure
    non-blind randomized two-arm clinical trial study in two groups of growth hormone-receiving and non-growth-hormone patients in patients with recurrent implantation failure
    مطالعه کارازمایی بالینی دوبازویی تصادفی سازی شده یک سو کور در دوگروه دریافت کننده هورمون رشد وبدون هورمون رشد در بیماران باشکست مکرر لانه گزینی
    مطالعه کارازمایی بالینی دوبازویی تصادفی سازی شده بدون کورسازی در دوگروه دریافت کننده هورمون رشد وبدون هورمون رشد در بیماران باشکست مکرر لانه گزینی
    In this prospective study which will be done by clinical trial, the patients with recurrent implantation failure were divided into an intervention group (receiving 8 units of the growth hormone from the beginning of the daily subcutaneous injection of estradiol valerate to the beginning of progesterone injection) and a control group through blocked randomization. It will be a single-blind trial for the researchers. The researchers responsible for data collection and those who assess outcomes will not have access to patients’ medical records and clinical report forms. They will simply collect patients’ outcomes based on the initial list for participation in the research.
    In this clinical trial, the patients were divided into an intervention group (receiving daily subcutaneous 8 units of the growth hormone from the beginning of the daily of estradiol valerate to the beginning of progesterone injection) and a control group. The researchers responsible for data collection and those who assess outcomes will not have access to patients’ medical records and clinical report forms. They will simply collect patients’ outcomes based on the initial list for participation in the research.
    در این مطالعه آینده نگر به روش کارازمایی بالینی بیماران شکست مکرر لانه گزینی به صورت تصادفی سازی غیر طبقه بندی blocked Randomization دردو گروه کیس دریافت کننده هورمون رشد ۸ واحد از روز شروع استرادیول روزانه زیرجلدی تا روز شروع پروژسترون وکنترل بدون دریافت هورمون رشد تقسیم بندی میشوند. کور سازی یک سو یک سو کوردر سطح پژوهشگران اجرای مطالعه میباشد مسئولین جمع آوری داده ها و کسانی که پیامد را ارزیابی می کنند دسترسی به اطلاعات پرونده بیماران ویا فرمهای گزارش بالینی بیماران ندارند و صرفا برمبنای لیست اولیه شرکت در مطالعه با بیماران اطلاعات پیامد بیماران را جمع آوری خواهند کرد.
    در این مطالعه کارازمایی با'لینی بیماران به صورت تصادفی سازی شده بر اساس مرکز دردو گروه کیس دریافت کننده هورمون رشد روزانه زیرجلدی ۸ واحد از روز شروع استرادیول روزانه تا روز شروع پروژسترون وکنترل بدون دریافت هورمون رشد تقسیم بندی میشوند. مسئولین جمع آوری داده ها و کسانی که پیامد را ارزیابی می کنند دسترسی به اطلاعات پرونده بیماران ویا فرمهای گزارش بالینی بیماران ندارند و صرفا برمبنای لیست اولیه شرکت در مطالعه با بیماران اطلاعات پیامد بیماران را جمع آوری خواهند کرد.
    Inclusion criteria: Women between the ages of 22 and 38, recurrent Implantation Failure between 3 to 6 times , BMI≤ 30 Exclusion criteria: Underlying disease such as: diabetes, Hypertension, Congenital uterine anomalies Endometrial adhesions , submucosal myomas
    Inclusion criteria: Women between the ages of 22 and 39, unexplained recurrent Implantation Failure ≥3 in Fet cycle Exclusion criteria: known cause of implantation failure such as Underlying disease such as: diabetes, Hypertension, Congenital uterine anomalies Endometrial adhesions , submucosal myomas
    شرایط ورود: زنان سنین 22 تا 38 سال شکست مکرر لانه گزینی بین 3 تا 6، BMI≤ 30 شرایط عدم ورود: بیماری زمینه ای مثل دیابت و فشارخون آنومالی رحمی چسبندگی اندومتر ,میوم ساب موکوز
    شرایط ورود: زنان سنین 22 تا 39 سال و شکست مکرر لانه گزینی بدون توضیح ≥3 در سیکل فریز شرایط عدم ورود: علت شناخته شده شکست مکرر نظیر بیماری زمینه ای مثل دیابت و فشارخون آنومالی رحمی چسبندگی اندومتر ,میوم ساب موکوز
    The intervention group includes the patients with recurrent implantation failure who will receive the intervention of the growth hormone. The control group includes the patients with recurrent implantation failure who will not receive the intervention of the growth hormone.
    The intervention group includes the patients with RIF who will receive the intervention of the growth hormone in FET cycle . The control group includes the patients with RIF who will not receive the intervention of the growth hormone in FET cycle.
    گروه مداخله شامل بیماران با شکست مکرر لانه گزینی است که مداخله هورمون رشد را دریافت می کنند. گروه کنترل شامل بیماران با شکست مکرر لانه گزینی است که مداخله هورمون رشد را دریافت نمی کنند.
    گروه مداخله شامل بیماران با شکست مکرر لانه گزینی است که مداخله هورمون رشد را در سیکل فریز دریافت می کنند. گروه کنترل شامل بیماران با شکست مکرر لانه گزینی است که مداخله هورمون رشد را در سیکل فریز دریافت نمی کنند.
    Clinical pregnancy by defining the observation of pregnancy sac on transvaginal ultrasound in the 5th week of pregnancy
    Clinical pregnancy: the observation of pregnancy sac on transvaginal ultrasound in the 5th week ; Ongoing pregnancy:12 week gestation Live birth rate
    بارداری بالینی با تعریف مشاهده ساک حاملگی در سونوگرافی ترانس واژینال در هفنه 5 حاملگی
    بارداری بالینی:مشاهده ساک حاملگی در سونوگرافی ترانس واژینال در هفنه 5 ؛ حاملگی ادامه دار : 12هفته حاملگی تولد زنده

  • General information

    20
    22
    40
    39
    Single blinded
    Not blinded
    1
    70
    356
    empty
    Sponsor change Increase of sample size Some centers was added to the study Since the intervention, inclusion and exclusion criteria and assessed outcomes were not changed and also the sample sized is increased only due to change the study to a multi-center one , there is no ethical consideration related to the trial. Then a new ethical code was not requested.
    empty
    تغییر اسپانسر مطالعه. افزوده شدن حجم نمونه. افزایش مراکز بیمارگیری. با توجه به عدم تغییر در مداخله ، معیارهای ورود و خروج مطالعه و نیز پیامدهای مورد ارزیابی ، و افزایش حجم نمونه بعلت چند مرکز شدن مطالعه ، ملاحظه اخلاقی خاصی در مطالعه بنظر نمی رسد . لذا برای صدور کد اخلاق جدید درخواستی صورت نگرفته است.
    The effect of growth hormone on endometrial acceptance and increasing pregnancy success in women with recurrent implantation failure
    The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure: A multicenter clinical randomized study.
    تاثیر هورمون رشد بر پذیرش اندومتر وافزایش موفقیت حاملگی در زنان با شکست مکرر لانه گزینی
    تاثیر هورمون رشد برافزایش موفقیت حاملگی در زنان با شکست مکرر لانه گزینی بدون توضیح : یک مطالعه تصادفی شده چندمرکزی.
    The effect of growth hormone on endometrial acceptance and increasing pregnancy success in women with recurrent implantation failure
    The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure: A multicenter clinical randomized study.
    تاثیر هورمون رشد بر پذیرش اندومتر وافزایش موفقیت حاملگی در زنان با شکست مکرر لانه گزینی
    تاثیر هورمون رشد برافزایش موفقیت حاملگی در زنان با شکست مکرر لانه گزینی بدون توضیح : یک مطالعه تصادفی شده چندمرکزی.
    Having Grade A good fetal inclusion criteria, blastocysts with sufficient number, have a history of more than two previous failures despite good fetal transfer, no previous hormone growth cycle, no other interventions in this cycle, no donation cycle, no hormone contraindications, not having hydrosalpinx.
    have a history of more than two previous unexplained IVF failures (3≤)(despite transfer of minimum one good grade A blastocyst embryo) , no previous hormone growth cycle, no other interventions in this cycle(hystroscopy and Imunomodolator drugs ), no donation cycle, no hormone contraindications, not having hydrosalpinx, , having at least one good grade A blastocyst freezed embryo for transfer , FSH≤10, AMH≥1.8
    کریتریای ورود جنین خوب گرید A بلاستوسیت با تعداد خوب وجود داشته باشد ،سابقه بیش از دوشکست قبلی علی رغم انتقال جنین خوب داشته باشد ، سیکل قبلی هورمون رشد نگرفته باشد ،در این سیکل اینترونشن دیگرنداشته باشد ،سیکلهای اهدا نباشد ،منع مصرف هورمون نداشته باشد ،هیدروسالپنکس نداشته باشد.
    کریتریای ورود ،سابقه بیش از دوشکست قبلی(3≤) ای وی اف بدون توضیح ( حداقل یک جنین خوب گرید A بلاستوسیت منتقل شده باشد ) ، سیکل قبلی هورمون رشد نگرفته باشد ،در این سیکل اینترونشن دیگرنداشته باشد (هیستروسکوپی و داروهای ایمونومدولاتور)،سیکلهای اهدا نباشد ،منع مصرف هورمون نداشته باشد و داشتن حداقل یک جنین فریز خوب با گرید A بلاستوسیست و FSH≤10, AMH≥1.8
    Age over 40 years, endometriosis, severe oligospermia, (morphology count <1%), patients with hydrosalpinx, kidney and liver diseases, diabetes and thyroid and autoimmune diseases and local allergic reactions and benign increase in intracranial pressure
    Age≥ 40 years, BMI≥30, endometriosis, severe oligospermia, (Sperm count <5 ×106 /mL ,Normal morphology <2% in the sperm analysis test ) DFI ≤30% , patients with hydrosalpinx, kidney and liver diseases, diabetes,hypertention and thyroid( anti-Tpo>500) and autoimmune diseases and local allergic reactions and benign increase in intracranial pressure, submucosal myoma, metabolic syndrome, sex selection , karyotype disorder, uterian anomalis, Synechsia, Hx of thin enodmetrium(endometrial line<7mm) , no patient consent
    سن بالای 40سال ،بیماری اندومتریوز ،الیگواسپرمی شدید (morphology count<1درصد) ،بیماران با هیدروسالپنکس ،بیماری کلیوی وکبدی و دیابت و تیروییدواتوایمیون وواکنش های موضعی آلرژیک وافزایش خوش خیم فشار داخل جمجمه ای
    سن ≥40سال ، BMI≥30 ,بیماری اندومتریوز ،الیگوتراتواسپرمی شدید ( Sperm count <5 ×106 /mL . Normal morphology <2% in the sperm analysis test ) DFI > 30%، بیماران با هیدروسالپنکس ،بیماری کلیوی وکبدی و دیابت، فشارخون و تیرویید(anti-Tpo>500) و اتوایمیون وواکنش های موضعی آلرژیک وافزایش خوش خیم فشار داخل جمجمه ای،میوم ساب موکوز،سندرم متابولیک ، انتخاب جنسیت ، اختلال کاریوتیپ ، آنومالیهای مادرزادی , چسبندگی‌های رحمی ، سابقه ضخامت اندومترنازک( ضخامت اندومتر <7میلی متر) و عدم رضایت بیمار
    Evaluation of the effect of growth hormone injection on pregnancy outcomes in patients with recurrent implantation failure
    The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure ( undergoing frozen embryo transfer): A multicenter clinical randomized study.
    بررسی اثر تزریق هورمون رشد برنتایج بارداری در بیماران با شکست مکرر لانه گزینی
    تاثیر هورمون رشد برافزایش موفقیت حاملگی در زنان با شکست مکرر لانه گزینی بدون توضیح (در سیکل انتقال فریز) : یک مطالعه تصادفی شده مولتی سنتر.
    The researchers responsible for data collection and those who assess outcomes will not have access to patients’ medical records and clinical report forms. They will simply collect patients’ outcomes based on the initial list for participation in the research. These people are not aware of the type of assignment of participants to the control and intervention group.
    مسئولین جمع آوری داده ها و کسانی که پیامد را ارزیابی می کنند دسترسی به اطلاعات پرونده بیماران ویا فرمهای گزارش بالینی بیماران ندارند وصرفا برمبنای لیست اولیه شرکت در مطالعه با بیماران اطلاعات پیامد بیماران را جمع آوری خواهند کرد. این افراد از نوع تخصیص مشارکت کنندگان به گروه کنترل و مداخله آگاهی ندارند.

  • Health conditions studied

    #1
    Spontaneou
    N98.2
    O03
    Complications of attempted introduction of fertilized ovum following in vitro fertilization
    #2
    empty
    N97.2
    empty
    Female infertility of uterine origin
    empty
    Patients with recurrent implantation failure
    empty
    بیماران با شکست مکرر لانه گزینی

  • Primary outcomes

    #1
    Three months after taking the drug
    5-6 weeks after taking the drug
    سه ماه بعد از مصرف دارو
    5 - 6 هفته بعد از مصرف دارو
    The number of patients with BHCG positive is divided by the number of patients who had fetus transfer
    The number of patients with positive gestational sac divided by the number of patients who had embryo transfer
    تعداد بیماران باBHCG مثبت تقسیم بر تعداد بیماران که انتقال جنین داشتند
    تعداد بیماران با ساک حاملگی مثبت تقسیم بر تعداد بیماران که انتقال جنین داشتند

  • Secondary outcomes

    #1
    Endometrial acceptance
    Endometrial receptivity
    Three months after taking the drug
    2 weeks after taking the drug
    سه ماه بعد از مصرف دارو
    2هفته بعد از مصرف دارو
    Definition of chemical pregnancy: Patients with a positive pregnancy test
    measurement of sub endometrial flow by power Doppler sono and endometrial volume and thickness by 3D and 2D ultrasonograghy
    تعریف حاملگی شیمیایی : بیماران با تست حاملگی مثبت
    اندازه گیری ساب اندومتریال فلو با پاور داپلر سونو و حجم وضخامت اندومتر با سونو سه بعدی و دوبعدی
    #2
    empty
    chemical pregnancy rate : the rate of positive pregnancy test 2 weeks after embryo transfer
    empty
    میزان حاملگی شیمیایی : میزان تست حاملگی مثبت 2 هفته بعد از انتقال جنین
    empty
    2 weeks after embryo transfer
    empty
    دوهفته بعد از انتقال جنین
    empty
    evaluation of positive pregnancy test after transfer of blastocyst (s) embryo(s)
    empty
    بررسی تست حاملگی مثبت بعد از انتقال جنین بلاست
    #3
    empty
    implantation rate
    empty
    میزان لانه گزینی
    empty
    measurement of number gestational sac divided by number of blastocyst embryo transfer
    empty
    بررسی تعداد ساک مثبت بعد انتقال جنین بلاستوسیست توسط سونوگرافی
    empty
    evaluation of positive and number of intrauterine gestational sac after transfer of blastocyst (s) embryo(s) by ultrasonograghy
    empty
    اندازه گیری تعداد ساک حاملگی تقسیم بر تعداد جنین های بلاستوسیت منتقل شده
    #4
    empty
    live birth rate : number of delivery of viable fetuses(more than 28 weeks) divided by number of embryo transferred.
    empty
    میزان تولد زنده : تعداد تولدهای زنده قابل حیات (بیشتر از 28 هفته ) تقسیم بر تعداد انتقال جنین
    empty
    Gestational age more than 28 weeks of pregnancy
    empty
    سن حاملگی بیشتر از 28 هفته
    empty
    Delivery of viable fetuses after 28 after pregnancy
    empty
    تولد جنین قابل حیات بعد از هفته 28 حاملگی

  • Intervention groups

    #1
    Other
    Treatment - Drugs
    Intervention group: this study attempts to explore and assess 35 infertile women with further three recurrent implantation failures. This group will receive the growth hormone produced by CinnaGen Company for the frozen embryo transfer (FET). From the third day of menstruation, the oral estradiol valerate (6 mg/day) and subcutaneous injection of 8 units of the growth hormone will be prescribed. The injection of the growth hormone will be continued until the day on which progesterone is injected. Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial color Doppler sonography, endometrial thickness, endometrium, pulsatility index, resistance index, and left and right uterine artery are measured and the embryo is transferred then.
    Intervention group: this study attempts to explore and assess 178 infertile further three recurrent implantation failures. This group will receive the growth hormone produced by CinnaGen Company for the frozen embryo transfer (FET). From the third day of menstruation, after suppression of endogenous ovarian secretion by prescribing GnRH agonist in the 21day of the previous cycle ,oral estradiol valerate (6 mg/day) and subcutaneous injection of 8 units of the growth hormone will be prescribed. ( in patients with a regular menstruation no GnRH agonist suppression is done ). The injection of the growth hormone will be continued until the day on which progesterone is injected.(having a good trilaminar ,at least 7-8 mm endometrial thickness ). Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial flow , endometrial thickness and volume , endometrium pulsatility index, resistance index of left and right uterine arteris are measured by 2 D and 3D ultrasonography and power Doppler sonography and the embryo is transferred then.For luteal phase support , oral estradiol valerate pulse vaginal progesterone, Cyclogest ,( 400 mg BD) or combination of vaginal progesterone, Cyclogest ,( 400 mg BD) with intramuscular progestrone( 50 mg, every 3 day) is prescribed. 2 weeks after embryo transfer, the blood BHCG test is requested.
    گروه مداخله: در این تحقیق به بررسی وارزیابی 35خانم نابارور با سه بار بیشتر شکست لانه گزینی مکرر در گروه دریافت هورمون رشدشرکت سیناژن در انتقال جنین فریز از روز سوم پریود روزی 6میلی گرم استرادیول والرات خوراکی به همراه 8 واحد هورمون رشد با تزریق زیر جلدی تجویز میکنیم وتا هورمون رشد را تا روز تزریق پروژسترون ادامه میدهیم پنج روز قبل از انتقال جنین بلاست آمپول پروژسترون عضلانی به همراه 6 میلی گرم استرادیول والرات خوراکی تجویز میکنیم و صبح روز انتقال جنین سونوگرافی کالر داپلر ساب اندومتریال وضخامت اندومتر و اکو اندومتر و pulsatile Index و Resistance Index شریان رحمی دوطرف چپ وراست را اندازه گیری میکنیم و جنین را انتقال میدهیم لطفا بخش راهنما ی مربوط به این فیلد را بدقت مطالعه فرموده و اصلاحات لازم را انجام دهید.
    گروه مداخله: در این تحقیق به بررسی وارزیابی 178 خانم نابارور با سه بار بیشتر شکست لانه گزینی مکرر در گروه دریافت هورمون رشدشرکت سیناژن در انتقال جنین فریز از روز سوم می پردازیم از روز سوم قاعدگی بعد از ساپرشن ترشح اندوژن تخمدان با GnRH آگونیست در روز 21 پریودسیکل قبلی روزی 6میلی گرم استرادیول والرات خوراکی به همراه 8 واحد هورمون رشد با تزریق زیر جلدی تجویز میکنیم (در بیماران با پریودهای منظم ساپرشن با GnRH آگونیست انجام نمی شود )و هورمون رشد را تا روز تزریق پروژسترون ادامه میدهیم تا زمانی که اندومتر سه خطی مناسب در سونوگرافی با حداقل ضخامت 7 تا 8 میلی متر مشاهده شود. پنج روز قبل از انتقال جنین بلاست آمپول پروژسترون عضلانی به همراه 6 میلی گرم استرادیول والرات خوراکی تجویز میکنیم و صبح روز انتقال جنین توسط سونوگرافی پاور داپلر و سونوگرافی دوبعدی و سه بعدی بررسی فلوی ساب اندومتریال وضخامت و حجم اندومتر و اکو اندومتر و pulsatile Index و Resistance Index شریان های رحمی دوطرف چپ وراست را اندازه گیری میکنیم و جنین را انتقال میدهیم ساپورت فاز لوتیال با استروژن خوراکی و پروژسترون واژینال سیکلوژست (400 میلی گرم هر12 ساعت ) و یا ترکیب پروژسترون واژینال سیکلوژست (400 میلی گرم هر 12 ساعت ) با آمپول پروژسترون داخل عضلانی (50 میلی گرم هر 3 روز ) انجام میدهیم دوهفته بعد از انتقال جنین تست خون حاملگی را در خواست می کنیم . لطفا بخش راهنما ی مربوط به این فیلد را بدقت مطالعه فرموده و اصلاحات لازم را انجام دهید.
    #2
    N/A
    Treatment - Other
    Control group: This study seeks to explore and assess 35 infertile women with further three recurrent implantation failures. This group will not receive the growth hormone for the frozen embryo transfer (FET). From the third day of menstruation, the oral estradiol valerate (6 mg/day) will be prescribed. Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial color Doppler sonography, endometrial thickness, endometrium, pulsatility index, resistance index, and left and right uterine artery are measured and the embryo is transferred then.
    Control group: this study attempts to explore and assess 178 infertile further three recurrent implantation failures. From the third day of menstruation, after suppression of endogenous ovarian secretion by prescribing GnRH agonist in the 21day of the previous cycle ,oral estradiol valerate (6 mg/day) will be prescribed. ( in patients with a regular menstruation no GnRH agonist suppression is done ). Using estradiol valerate will be continued until the day on which progesterone is injected. .(having a good trilaminar , at least 7-8 mm endometrial thickness ). Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial flow , endometrial thickness and volume , endometrium pulsatility index, resistance index of left and right uterine arteris are measured by 2 D and 3D ultrasonography and power Doppler sonography and the embryo is transferred then. For luteal phase support , oral estradiol valerate pulse vaginal progesterone, Cyclogest ,( 400 mg BD) or combination of vaginal progesterone, Cyclogest ,( 400 mg BD) with intramuscular progestrone( 50 mg, every 3 day) is prescribed. 2 weeks after embryo transfer, the blood BHCG test is requested.are measured and the embryo is transferred then.
    گروه کنترل: در این تحقیق به بررسی وارزیابی 35خانم نابارور با سه بار بیشتر شکست لانه گزینی مکرر در گروه بدون دریافت هورمون رشد در انتقال جنین فریز از روز سوم پریود روزی 6 میلی گرم استرادیول والرات خوراکی تجویز میکنیم پنج روز قبل از انتقال جنین بلاست آمپول پروژسترون عضلانی به همراه 6 میلی گرم سترادیول والرات خوراکی تجویز میکنیم و صبح روز انتقال جنین سونوگرافی کالر داپلر ساب اندومتریال وضخامت اندومتر و اکو اندومتر و pulsatile Index و Resistance Index شریان رحمی دوطرف چپ وراست را اندازه گیری میکنیم و جنین را انتقال میدهیم.
    گروه کنترل: در این تحقیق به بررسی وارزیابی 178 خانم نابارور با سه بار بیشتر شکست لانه گزینی مکرر در گروه بدون دریافت هورمون رشد در انتقال جنین فریز از روز سوم می پردازیم از روز سوم قاعدگی بعد از ساپرشن ترشح اندوژن تخمدان با GnRH آگونیست در روز 21 پریودسیکل قبلی روزی 6میلی گرم استرادیول والرات خوراکی تجویز میکنیم (در بیماران با پریودهای منظم ساپرشن با GnRH آگونیست انجام نمی شود )و تا روز تزریق پروژسترون ادامه میدهیم (زمانی که اندومتر سه خطی مناسب در سونوگرافی با حداقل ضخامت 7 تا 8 میلی متر مشاهده شود ). پنج روز قبل از انتقال جنین بلاست آمپول پروژسترون عضلانی به همراه 6 میلی گرم استرادیول والرات خوراکی تجویز میکنیم و صبح روز انتقال جنین توسط سونوگرافی پاور داپلر و سونوگرافی دوبعدی و سه بعدی بررسی فلوی ساب اندومتریال وضخامت و حجم اندومتر و اکو اندومتر و pulsatile Index و Resistance Index شریان های رحمی دوطرف چپ وراست را اندازه گیری میکنیم و جنین را انتقال میدهیم ساپورت فاز لوتیال با استروژن خوراکی و پروژسترون واژینال سیکلوژست (400 میلی گرم هر12 ساعت ) و یا ترکیب پروژسترون واژینال سیکلوژست (400 میلی گرم هر 12 ساعت ) با آمپول پروژسترون داخل عضلانی (50 میلی گرم هر 3 روز ) انجام میدهیم دوهفته بعد از انتقال جنین تست خون حاملگی را در خواست می کنیم .

  • Recruitment centers

    #1
    Name of recruitment center - English: Jihad University Research Institute, Ibn Sina Infertility Center
    Name of recruitment center - Persian: پژوهشگاه جهاد دانشگاهی مرکز ناباروری ابن سینا
    Full name of responsible person - English: Soheila Ansaripour
    Full name of responsible person - Persian: سهیلا انصاری پور
    Street address - English: Shariati St., corner of Yakhchal St., No. 97, Jihad University, Ibn Sina Infertility Center
    Street address - Persian: خیابان شریعتی، نبش خیابان یخچال، پلاک نود وهفت، جهاد دانشگاهی، مرکز ناباروری ابن سینا
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1941913118
    Phone: +98 21 2243 2020
    Fax: +98 21 2243 2022
    Email: soh.ansaripour@gmail.com
    Web page address:
    Name of recruitment center - English: Avicenna Fertility Center
    Name of recruitment center - Persian: مرکز ناباروری ابن سینا
    Full name of responsible person - English: Soheila Ansaripour
    Full name of responsible person - Persian: سهیلا انصاری پور
    Street address - English: Yackchal junction
    Street address - Persian: خیابان شریعتی، نبش خیابان یخچال
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1936773493
    Phone: +98 21 2243 2020
    Fax: +98 21 2243 2022
    Email: soh.ansaripour@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: Akbarabadi Hospital
    Name of recruitment center - Persian: بیمارستان اکبرآبادی
    Full name of responsible person - English: Dr. Mahnaz Ashrafi
    Full name of responsible person - Persian: دکتر مهناز اشرفی
    Street address - English: Molavai St. Tehran. Iran
    Street address - Persian: تهران. خیابان مولوی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 11687 43514
    Phone: +98 21 5560 6034
    Fax:
    Email: ashrafi.m@iums.ac.ir
    Web page address:
    #3
    Name of recruitment center - English: Moheb Yas Hospital
    Name of recruitment center - Persian: بیمارستان محب یاس
    Full name of responsible person - English: Dr. Firoozeh Akbari Asbagh
    Full name of responsible person - Persian: دکتر فیروزه اکبری اسبق
    Street address - English: North Ostad Nejatollahi St. Karimkhan St. Tehran, Iran
    Street address - Persian: تهران. خیابان کریمخان زند ، خیابان استاد نجات الهی شمالی
    City - English: Tehran
    City - Persian: ایران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1598718311
    Phone: +98 21 4216 0000
    Fax:
    Email: F.AsbaghM.D@yahoo.com
    Web page address:
    #4
    Name of recruitment center - English: Imam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا
    Full name of responsible person - English: Dr. Nayereh Khadem Ghaebi
    Full name of responsible person - Persian: دکتر نیره خادم غائبی
    Street address - English: Bahar St. Mashhad
    Street address - Persian: مشهد، خیابان بهار
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9137913316
    Phone: +98 51 3854 3031
    Fax:
    Email: Khademn@mums.ac.ir
    Web page address:
    #5
    Name of recruitment center - English: East Azerbaijan ACECR ART center
    Name of recruitment center - Persian: مرکز درمان ناباروری جهاد دانشگاهی آذربایجان شرقی
    Full name of responsible person - English: Sedigheh Abdollahi fard
    Full name of responsible person - Persian: صدیقه عبدالهی فرد
    Street address - English: Jam Jame St
    Street address - Persian: خیابان جام جم
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166617753
    Phone: +98 41 3329 5730
    Fax:
    Email: Dr_s_abdollahi@yahoo.com
    Web page address:
    #6
    Name of recruitment center - English: Isfahan Fertility & Infertility Center
    Name of recruitment center - Persian: مرکز باروری و ناباروری اصفهان
    Full name of responsible person - English: Mohammad Hossein Nasr Isfahani
    Full name of responsible person - Persian: محمد حسین نصر اصفهانی
    Street address - English: Salman Farsi St
    Street address - Persian: خیابان سلمان فارسی
    City - English: Isfahan
    City - Persian: Isfahan
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: ​8158858151
    Phone: +98 31 3267 0030
    Fax:
    Email: Nasr.royan@gmail.com
    Web page address:
    #7
    Name of recruitment center - English: Taleqani hospital
    Name of recruitment center - Persian: بیمارستان طالقانی
    Full name of responsible person - English: Nasrin Saharkhiz
    Full name of responsible person - Persian: نسرین سحرخیز
    Street address - English: Yemen st. Velenjak
    Street address - Persian: ولنجک. خیابان یمن
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985711151
    Phone: +98 21 2243 2560
    Fax:
    Email: Saharkhiz1377@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Ibn Sina University Jihad Infertility Center
    Name of organization / entity - Persian: مرکز ناباروری جهاد دانشگاهی ابن سینا
    Full name of responsible person - English: Dr. Mina Ataei
    Full name of responsible person - Persian: دکتر مینا عطائی
    Street address - English: Marzdaran Town, Isar St., Motamedi St., Sahel Alley, No. 2
    Street address - Persian: شهرک مرزداران، خیابان ایثار، خیابان معتمدی، کوچه ساحل، پلاک 2
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1941913114
    Phone: +98 21 2243 2020
    Fax: +98 21 2243 2020
    Email: Atlee.mina@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Avicenna Reseacrh Institute
    Name of organization / entity - Persian: پژوهشگاه ابن سینا
    Full name of responsible person - English: Mohammad Reza Sadeghi
    Full name of responsible person - Persian: محمد رضا صادقی
    Street address - English: Avincenna research institute , Daneshjou Blvrd, Evin
    Street address - Persian: اوین . بلوار دانشجو
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1941913114
    Phone: +98 21 2243 2020
    Fax: +98 21 2243 2021
    Email: Sadeghi@ari.ir
    Web page address:
    Yes
    empty
    100
    50
    Avicenna University Jihad Infertility Center Avicenna
    ACECR
    مرکز ناباروری جهاد دانشگاهی ابن سینا
    جهاد دانشگاهی
    #2
    contact.organization_id:
    Name of organization / entity - English: CinnaGen company
    Name of organization / entity - Persian: شرکت سیناژن
    Full name of responsible person - English: Dr.Haleh Hamedifar
    Full name of responsible person - Persian: دکتر هاله حامدی فر
    Street address - English: No.72,CinnaGen research and production company.Simindasht industrial park,Karaj, Alborz, Iran.
    Street address - Persian: کرج. جاده ملارد به طرف جاده شهریار. شهرک صنعتی سیمین دشت. بین خیابان 5و6 نبش میدان سوم. پ72
    City - English: Karaj
    City - Persian: کرج
    Province: Alborz
    Country: Iran (Islamic Republic of)
    Postal code: 3165933155
    Phone: +98 26 3667 0980
    Fax:
    Email: Cinnagen@Cinnagen
    Web page address:
    empty
    Yes
    empty
    50
    empty
    Private
    empty
    Domestic
    empty
    Industry
    empty
    CinnaGen company
    empty
    شرکت سیناژن

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Avicenna University Jihad Infertility Center
    Name of organization / entity - Persian: مرکز ناباروری جهاد دانشگاهی ابن سینا
    Full name of responsible person - English: Dr. Mina Ataei
    Full name of responsible person - Persian: دکتر مینا عطائی
    Position - English: Infertility Fellowship
    Position - Persian: فلوشیپ ناباروری
    Latest degree: sub_specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Marzdaran Town, Isar St., Motamedi St., Sahel Alley, No. 2
    Street address - Persian: شهرک مرزداران، خیابان ایثار، خیابان معتمدی، کوچه ساحل، پلاک 2
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1941913114
    Phone: +98 21 2243 2020
    Mobile: +98 912 667 1381
    Fax:
    Email: Atlee.mina@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Avicenna Infertility Center
    Name of organization / entity - Persian: مرکز ناباروری ابن سینا
    Full name of responsible person - English: Dr. Mina Ataei
    Full name of responsible person - Persian: دکتر مینا عطائی
    Position - English: Infertility Fellowship
    Position - Persian: فلوشیپ ناباروری
    Latest degree: sub_specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Yakhchal Junction, Shariati st.
    Street address - Persian: خیابان شریعتی، نبش یخچال
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1936773493
    Phone: +98 21 2243 2020
    Mobile: +98 912 667 1381
    Fax:
    Email: Ataee.mina@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Avicenna University Jihad Infertility Center
    Name of organization / entity - Persian: مرکز ناباروری جهاد دانشگاهی ابن سینا
    Full name of responsible person - English: Dr. Mina Ataei
    Full name of responsible person - Persian: دکتر مینا عطائی
    Position - English: Infertility Fellowship
    Position - Persian: فلوشیپ ناباروری
    Latest degree: sub_specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Marzdaran Town, Isar St., Motamedi St., Sahel Alley, No. 2
    Street address - Persian: شهرک مرزداران، خیابان ایثار، خیابان معتمدی، کوچه ساحل، پلاک 2
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1941913114
    Phone: +98 21 2243 2020
    Mobile: +98 912 667 1381
    Fax:
    Email: Atlee.mina@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Avicenna fertility Center
    Name of organization / entity - Persian: مرکز ناباروری جهاد دانشگاهی ابن سینا
    Full name of responsible person - English: ِDr Soheila Ansaripour
    Full name of responsible person - Persian: دکتر سهیلا انصاری پور
    Position - English: Infertility Fellowship
    Position - Persian: فلوشیپ ناباروری
    Latest degree: sub_specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Yakhchal junction, Shariati st.
    Street address - Persian: خیابان شریعتی نبش یخچال
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1936773493
    Phone: +98 21 2243 2020
    Mobile: +98 912 396 3751
    Fax:
    Email: soh.ansaripour@gmail.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Avicenna University Jihad Infertility Center
    Name of organization / entity - Persian: مرکز ناباروری جهاد دانشگاهی ابن سینا
    Full name of responsible person - English: Dr. Mina Ataei
    Full name of responsible person - Persian: دکتر مینا عطائی
    Position - English: Infertility Fellowship
    Position - Persian: فلوشیپ ناباروری
    Latest degree: sub_specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Marzdaran Town, Isar St., Motamedi St., Sahel Alley, No. 2
    Street address - Persian: شهرک مرزداران، خیابان ایثار، خیابان معتمدی، کوچه ساحل، پلاک 2
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1941913114
    Phone: +98 21 2243 2020
    Mobile: +98 912 667 1381
    Fax:
    Email: Atlee.mina@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Avicenna fertility Center
    Name of organization / entity - Persian: مرکز ناباروری ابن سینا
    Full name of responsible person - English: Arash Mohazab
    Full name of responsible person - Persian: آرش مهذب
    Position - English: Methodologist
    Position - Persian: مشاوره متدولوژی
    Latest degree: med_doctor
    Area of specialty/work: 2
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Yakhchal Junction, Shariati st.
    Street address - Persian: خیابان شریعتی، نبش یخچال
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1936773493
    Phone: +98 21 23519
    Mobile: +98 912 610 5325
    Fax:
    Email: amohazzab@yahoo.com
    Web page address:

  • Sharing plan

    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    empty
    Ethical concerns
    empty
    ملاحظات اخلاقی
    Effect of growth hormone in endometrial respectivity in patients with Recurrent Implantation Failure
    Undefined plan
    تاثیر هورمون رشد بر پذیرش رحمی در بیماران با شکست مکرر لانه گزینی
    برنامه انتشار آن هنوز مشخص نیست.
    Up to one year after the publication of the article
    Undefined plan
    تا یکسال بعد از چاپ مقاله
    برنامه انتشار آن هنوز مشخص نیست.
    other researchers and physicians
    Undefined plan
    سایر محققین و پزشکان
    برنامه انتشار آن هنوز مشخص نیست.
    Using in meta-analysis studies
    Undefined plan
    استفاده در مطالعات متاآنالیز
    برنامه انتشار آن هنوز مشخص نیست.
    Marzdaran Town, Isar St., Motamedi St., Sahel Alley, No. 2 Avicenna University Jihad Infertility Center Dr. Mina Ataei Tell: 00982122432020
    Dr. Mina Ataei
    شهرک مرزداران، خیابان ایثار، خیابان معتمدی، کوچه ساحل، پلاک 2 مرکز ناباروری جهاد دانشگاهی ابن سینا دکتر مینا عطائی تلفن 00982122432020
    دکتر مینا عطائی
    Email to corresponding author Dr Mina Ataei Ataee.mina@yahoo.com
    Email to corresponding Dr Mina Ataei Ataee.mina@yahoo.com
    ایمیل به نویسنده مسول دکتر مینا عطائی Ataee.mina@yahoo.com
    ایمیل به مسول کارآزمایی دکتر مینا عطائی Ataee.mina@yahoo.com

Protocol summary

Study aim
To evaluate the effect of the growth hormone on the pregnancy outcomes of the patients with unexplained recurrent implantation failure Qualitative evaluation of the uterus after the intervention by help of vaginal sonography, two- dimensional and three-dimensional Doppler vaginal ultrasound
Design
non-blind randomized two-arm clinical trial study in two groups of growth hormone-receiving and non-growth-hormone patients in patients with recurrent implantation failure
Settings and conduct
In this clinical trial, the patients were divided into an intervention group (receiving daily subcutaneous 8 units of the growth hormone from the beginning of the daily of estradiol valerate to the beginning of progesterone injection) and a control group. The researchers responsible for data collection and those who assess outcomes will not have access to patients’ medical records and clinical report forms. They will simply collect patients’ outcomes based on the initial list for participation in the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women between the ages of 22 and 39, unexplained recurrent Implantation Failure ≥3 in Fet cycle Exclusion criteria: known cause of implantation failure such as Underlying disease such as: diabetes, Hypertension, Congenital uterine anomalies Endometrial adhesions , submucosal myomas
Intervention groups
The intervention group includes the patients with RIF who will receive the intervention of the growth hormone in FET cycle . The control group includes the patients with RIF who will not receive the intervention of the growth hormone in FET cycle.
Main outcome variables
Clinical pregnancy: the observation of pregnancy sac on transvaginal ultrasound in the 5th week ; Ongoing pregnancy:12 week gestation Live birth rate

General information

Reason for update
Sponsor change Increase of sample size Some centers was added to the study Since the intervention, inclusion and exclusion criteria and assessed outcomes were not changed and also the sample sized is increased only due to change the study to a multi-center one , there is no ethical consideration related to the trial. Then a new ethical code was not requested.
Acronym
IRCT registration information
IRCT registration number: IRCT20201003048912N1
Registration date: 2020-12-21, 1399/10/01
Registration timing: registered_while_recruiting

Last update: 2021-08-23, 1400/06/01
Update count: 1
Registration date
2020-12-21, 1399/10/01
Registrant information
Name
Mina Ataei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
m.ataee@abz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure: A multicenter clinical randomized study.
Public title
The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure: A multicenter clinical randomized study.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
have a history of more than two previous unexplained IVF failures (3≤)(despite transfer of minimum one good grade A blastocyst embryo) , no previous hormone growth cycle, no other interventions in this cycle(hystroscopy and Imunomodolator drugs ), no donation cycle, no hormone contraindications, not having hydrosalpinx, , having at least one good grade A blastocyst freezed embryo for transfer , FSH≤10, AMH≥1.8
Exclusion criteria:
Age≥ 40 years, BMI≥30, endometriosis, severe oligospermia, (Sperm count <5 ×106 /mL ,Normal morphology <2% in the sperm analysis test ) DFI ≤30% , patients with hydrosalpinx, kidney and liver diseases, diabetes,hypertention and thyroid( anti-Tpo>500) and autoimmune diseases and local allergic reactions and benign increase in intracranial pressure, submucosal myoma, metabolic syndrome, sex selection , karyotype disorder, uterian anomalis, Synechsia, Hx of thin enodmetrium(endometrial line<7mm) , no patient consent
Age
From 22 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 356
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks with size 4 in www.sealedenvelope.com web site
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure ( undergoing frozen embryo transfer): A multicenter clinical randomized study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committe of Avicenna research institue
Street address
Yakhchal junction, Shariati st.
City
Tehran
Province
Tehran
Postal code
1936773493
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1399.005

Health conditions studied

1

Description of health condition studied
Patients with recurrent implantation failure
ICD-10 code
N98.2
ICD-10 code description
Complications of attempted introduction of fertilized ovum following in vitro fertilization

2

Description of health condition studied
Patients with recurrent implantation failure
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin

Primary outcomes

1

Description
Pregnancy rate
Timepoint
5-6 weeks after taking the drug
Method of measurement
The number of patients with positive gestational sac divided by the number of patients who had embryo transfer

Secondary outcomes

1

Description
Endometrial receptivity
Timepoint
2 weeks after taking the drug
Method of measurement
measurement of sub endometrial flow by power Doppler sono and endometrial volume and thickness by 3D and 2D ultrasonograghy

2

Description
chemical pregnancy rate : the rate of positive pregnancy test 2 weeks after embryo transfer
Timepoint
2 weeks after embryo transfer
Method of measurement
evaluation of positive pregnancy test after transfer of blastocyst (s) embryo(s)

3

Description
implantation rate
Timepoint
measurement of number gestational sac divided by number of blastocyst embryo transfer
Method of measurement
evaluation of positive and number of intrauterine gestational sac after transfer of blastocyst (s) embryo(s) by ultrasonograghy

4

Description
live birth rate : number of delivery of viable fetuses(more than 28 weeks) divided by number of embryo transferred.
Timepoint
Gestational age more than 28 weeks of pregnancy
Method of measurement
Delivery of viable fetuses after 28 after pregnancy

Intervention groups

1

Description
Intervention group: this study attempts to explore and assess 178 infertile further three recurrent implantation failures. This group will receive the growth hormone produced by CinnaGen Company for the frozen embryo transfer (FET). From the third day of menstruation, after suppression of endogenous ovarian secretion by prescribing GnRH agonist in the 21day of the previous cycle ,oral estradiol valerate (6 mg/day) and subcutaneous injection of 8 units of the growth hormone will be prescribed. ( in patients with a regular menstruation no GnRH agonist suppression is done ). The injection of the growth hormone will be continued until the day on which progesterone is injected.(having a good trilaminar ,at least 7-8 mm endometrial thickness ). Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial flow , endometrial thickness and volume , endometrium pulsatility index, resistance index of left and right uterine arteris are measured by 2 D and 3D ultrasonography and power Doppler sonography and the embryo is transferred then.For luteal phase support , oral estradiol valerate pulse vaginal progesterone, Cyclogest ,( 400 mg BD) or combination of vaginal progesterone, Cyclogest ,( 400 mg BD) with intramuscular progestrone( 50 mg, every 3 day) is prescribed. 2 weeks after embryo transfer, the blood BHCG test is requested.
Category
Treatment - Drugs

2

Description
Control group: this study attempts to explore and assess 178 infertile further three recurrent implantation failures. From the third day of menstruation, after suppression of endogenous ovarian secretion by prescribing GnRH agonist in the 21day of the previous cycle ,oral estradiol valerate (6 mg/day) will be prescribed. ( in patients with a regular menstruation no GnRH agonist suppression is done ). Using estradiol valerate will be continued until the day on which progesterone is injected. .(having a good trilaminar , at least 7-8 mm endometrial thickness ). Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial flow , endometrial thickness and volume , endometrium pulsatility index, resistance index of left and right uterine arteris are measured by 2 D and 3D ultrasonography and power Doppler sonography and the embryo is transferred then. For luteal phase support , oral estradiol valerate pulse vaginal progesterone, Cyclogest ,( 400 mg BD) or combination of vaginal progesterone, Cyclogest ,( 400 mg BD) with intramuscular progestrone( 50 mg, every 3 day) is prescribed. 2 weeks after embryo transfer, the blood BHCG test is requested.are measured and the embryo is transferred then.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Avicenna Fertility Center
Full name of responsible person
Soheila Ansaripour
Street address
Yackchal junction
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Fax
+98 21 2243 2022
Email
soh.ansaripour@gmail.com

2

Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Dr. Mahnaz Ashrafi
Street address
Molavai St. Tehran. Iran
City
Tehran
Province
Tehran
Postal code
11687 43514
Phone
+98 21 5560 6034
Email
ashrafi.m@iums.ac.ir

3

Recruitment center
Name of recruitment center
Moheb Yas Hospital
Full name of responsible person
Dr. Firoozeh Akbari Asbagh
Street address
North Ostad Nejatollahi St. Karimkhan St. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0000
Email
F.AsbaghM.D@yahoo.com

4

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Nayereh Khadem Ghaebi
Street address
Bahar St. Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Khademn@mums.ac.ir

5

Recruitment center
Name of recruitment center
East Azerbaijan ACECR ART center
Full name of responsible person
Sedigheh Abdollahi fard
Street address
Jam Jame St
City
Tabriz
Province
East Azarbaijan
Postal code
5166617753
Phone
+98 41 3329 5730
Email
Dr_s_abdollahi@yahoo.com

6

Recruitment center
Name of recruitment center
Isfahan Fertility & Infertility Center
Full name of responsible person
Mohammad Hossein Nasr Isfahani
Street address
Salman Farsi St
City
Isfahan
Province
Isfehan
Postal code
​8158858151
Phone
+98 31 3267 0030
Email
Nasr.royan@gmail.com

7

Recruitment center
Name of recruitment center
Taleqani hospital
Full name of responsible person
Nasrin Saharkhiz
Street address
Yemen st. Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
Saharkhiz1377@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Avicenna Reseacrh Institute
Full name of responsible person
Mohammad Reza Sadeghi
Street address
Avincenna research institute , Daneshjou Blvrd, Evin
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 2243 2020
Fax
+98 21 2243 2021
Email
Sadeghi@ari.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
ACECR
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
CinnaGen company
Full name of responsible person
Dr.Haleh Hamedifar
Street address
No.72,CinnaGen research and production company.Simindasht industrial park,Karaj, Alborz, Iran.
City
Karaj
Province
Alborz
Postal code
3165933155
Phone
+98 26 3667 0980
Email
Cinnagen@Cinnagen
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CinnaGen company
Proportion provided by this source
50
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
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Avicenna Infertility Center
Full name of responsible person
Dr. Mina Ataei
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yakhchal Junction, Shariati st.
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Email
Ataee.mina@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Avicenna fertility Center
Full name of responsible person
ِDr Soheila Ansaripour
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yakhchal junction, Shariati st.
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Email
soh.ansaripour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Avicenna fertility Center
Full name of responsible person
Arash Mohazab
Position
Methodologist
Latest degree
Medical doctor
Other areas of specialty/work
Epidemiology
Street address
Yakhchal Junction, Shariati st.
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 23519
Email
amohazzab@yahoo.com

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
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undefined plan
When the data will become available and for how long
Undefined plan
To whom data/document is available
Undefined plan
Under which criteria data/document could be used
Undefined plan
From where data/document is obtainable
Dr. Mina Ataei
What processes are involved for a request to access data/document
Email to corresponding Dr Mina Ataei Ataee.mina@yahoo.com
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