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Protocol summary
This prospective controlled trial was designed to determine whether an additional GnRH agonist administered at the time of implantation for luteal phase support in FET cycles improves the pregnancy outcome in frozen-thawed embryo transfer cycles (FET) cycles. Inclision criteria was:frozen-thawed embryo transfer cycles;age 17 to 42 years.Exclusion criteria:history of endocrine or systemic diseases; endometriosis; cogenital uterine anomaly or aquired uterine diseases with or without operation; age below 17 years or above 42 years. In 200 FET cycles,Patients were administered estradiol valerate 6 milligrams daily and ASA 80 mg from day 2 of the cycle.vaginal sonography eas done on day ; since the endometrial thickness reached 8 mm,daily vaginal progesterone suppositories(total dose 800 mg daily) was administered . Randomization was done on the day of embryo transfer by a computer-generated table.Blindness was done for researchers.Patients were divided to group 1(n=100) to whom a single dose of GnRH agonist( 0.1 mg triptorelin) was administered three days after transfer and group 2 (n=100) ,who did not receive agonist.Both groups received daily vaginal progesterone suppositories(800 mg daily) plus estradiol valerate( 6 mg dai-ly).primary outcome measure was clinical pregnancy rate.secondary outcome measures were implantation rate,chemical ,ongoing pregnancy rate and abortion rate ..
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This prospective controlled trial was designed to determine whether an additional GnRH agonist administered at the time of implantation for luteal phase support in FET cycles improves the pregnancy outcome in frozen-thawed embryo transfer cycles (FET) cycles. Inclision criteria was:frozen-thawed embryo transfer cycles;age 17 to 42 years.Exclusion criteria:history of endocrine or systemic diseases; endometriosis; cogenital uterine anomaly or aquired uterine diseases with or without operation; age below 17 years or above 42 years. In 200 FET cycles,Patients were administered estradiol valerate 6 milligrams daily and ASA 80 mg from day 2 of the cycle.vaginal sonography eas done on day ; since the endometrial thickness reached 8 mm,daily vaginal progesterone suppositories(total dose 800 mg daily) was administered . Randomization was done on the day of embryo transfer by a computer-generated table.Blindness was done for researchers.Patients were divided to group 1(n=100) to whom a single dose of GnRH agonist( 0.1 mg triptorelin) was administered three days after transfer and group 2 (n=100) ,who did not receive agonist.Both groups received daily vaginal progesterone suppositories(800 mg daily) plus estradiol valerate( 6 mg dai-ly).primary outcome measure was clinical pregnancy rate.secondary outcome measures were implantation rate,chemical ,ongoing pregnancy rate and abortion rate ..
این مطالعه که از نوع کارازمایی بالینی موازی، تصادفی و یک سو کور شده می باشد، جهت بررسی اثر اضافه کردن آگونیست GnRH به درمان استاندارد بیماران در سیکلهای انتقال جنین برگشت از فریز، طراحی شده است .شرایط ورود به مطالعه: بیماران دارای جنین فریز شده در سیکل های قبلی یا به علت خطر OHSS وشرایط یا به علت وجود جنین های اضافی؛ سن بین 17 تا 40 سال.شرایط خروج از مطالعه:دریافت کنندگان اووسیت اهدایی؛ سابقه بیماری های سیستمیک یا اندوکرین ؛ اندومتریوز ؛ ضایعات اکتسابی یا مادرزادی داخل رحمی با یا بدون عمل جراحی قبلی؛سن زیر 17 یا بالای 40 . بیماران در روز دوم سیکل قاعدگی تحت سونوگرافی واژینال پایه قرار میگیرند. به بیماران از روز دوم سیکل قاعدگی روزانه 6 میلی گرم استرادیول خوراکی داده می شودر روز 12 سیکل، بیماران سونوگرافی می شوند. پس از رسیدن ضخامت اندومتر به 8 میلی متر یا بیشتر پروژسترون 800 میلی گرم روزانه تجویز شده و سپس انتقال جنین برگشت از فریزدر مرحله Cleavage صورت می گیرد.در روز انتقال، بیماران به صورت تصادفی بر اساس جدول اعداد کامپیوتری به دو گروه تقسیم می شوندکورسازی برای اندازه گیری کنندگان پیامدهای مطالعه ( پژوهشگران)انجام شده،یک گروه سه روز بعد از انتقال،یک عدد آمپول دکاپپتیل 0.1 میلی گرمی(Triptorelin 0.1 (زیرجلدی دریافت خواهند کرد و گروه دیگر دارو نخواهند گرفت.به هر دو گروه شیاف پروژسترون واژینال (800 میلی گرم روزانه) و قرص استرادیول والرات(6 میلی گرم روزانه)داده می شود.پیامد اولیه میزان حاملگی شیمیایی است.پیامد ثانویه ،implantation rateو میزان حاملگی شیمیایی،ongoing pregnancy rate و میزان سقط خواهد بود.
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این مطالعه که از نوع کارازمایی بالینی موازی، تصادفی و یک سو کور شده می باشد، جهت بررسی اثر اضافه کردن آگونیست GnRH به درمان استاندارد بیماران در سیکلهای انتقال جنین برگشت از فریز، طراحی شده است .شرایط ورود به مطالعه: بیماران دارای جنین فریز شده در سیکل های قبلی یا به علت خطر OHSS وشرایط یا به علت وجود جنین های اضافی؛ سن بین 17 تا 40 سال.شرایط خروج از مطالعه:دریافت کنندگان اووسیت اهدایی؛ سابقه بیماری های سیستمیک یا اندوکرین ؛ اندومتریوز ؛ ضایعات اکتسابی یا مادرزادی داخل رحمی با یا بدون عمل جراحی قبلی؛سن زیر 17 یا بالای 40 . بیماران در روز دوم سیکل قاعدگی تحت سونوگرافی واژینال پایه قرار میگیرند. به بیماران از روز دوم سیکل قاعدگی روزانه 6 میلی گرم استرادیول خوراکی داده می شودر روز 12 سیکل، بیماران سونوگرافی می شوند. پس از رسیدن ضخامت اندومتر به 8 میلی متر یا بیشتر پروژسترون 800 میلی گرم روزانه تجویز شده و سپس انتقال جنین برگشت از فریزدر مرحله Cleavage صورت می گیرد.در روز انتقال، بیماران به صورت تصادفی بر اساس جدول اعداد کامپیوتری به دو گروه تقسیم می شوندکورسازی برای اندازه گیری کنندگان پیامدهای مطالعه ( پژوهشگران)انجام شده،یک گروه سه روز بعد از انتقال،یک عدد آمپول دکاپپتیل 0.1 میلی گرمی(Triptorelin 0.1 (زیرجلدی دریافت خواهند کرد و گروه دیگر دارو نخواهند گرفت.به هر دو گروه شیاف پروژسترون واژینال (800 میلی گرم روزانه) و قرص استرادیول والرات(6 میلی گرم روزانه)داده می شود.پیامد اولیه میزان حاملگی شیمیایی است.پیامد ثانویه ،implantation rateو میزان حاملگی شیمیایی،ongoing pregnancy rate و میزان سقط خواهد بود.
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the additional GnRH agonist administered at the time of implantation for luteal phase support in FET cycles improves the pregnancy outcome in frozen-thawed embryo transfer cycles (FET) cycles
the additional GnRH agonist administered at the time of implantation for luteal phase support in FET cycles improves the pregnancy outcome in frozen-thawed embryo transfer cycles (FET) cycles
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ررسی اثر اضافه کردن آگونیست GnRH به درمان استاندارد بیماران در سیکلهای انتقال جنین برگشت از فریز،
ررسی اثر اضافه کردن آگونیست GnRH به درمان استاندارد بیماران در سیکلهای انتقال جنین برگشت از فریز،
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prospective parallel single blind controlled trial on 200 patients.for randomization was computerized with randomization table
prospective parallel single blind controlled trial on 200 patients.for randomization was computerized with randomization table
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کارازمایی بالینی موازی، تصادفی و یک سو کور شده,برای تصادفی سازی از جدول راندومیزاسیون استفاده شد
کارازمایی بالینی موازی، تصادفی و یک سو کور شده,برای تصادفی سازی از جدول راندومیزاسیون استفاده شد
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Patients were administered estradiol valerate 6 milligrams daily and ASA 80 mg from day 2 of the cycle.vaginal sonography eas done on day ; since the endometrial thickness reached 8 mm,daily vaginal progesterone suppositories(total dose 800 mg daily) was administered . Randomization was done on the day of embryo transfer by a computer-generated table.Blindness was done for researchers.Patients were divided to group 1(n=100) to whom a single dose of GnRH agonist( 0.1 mg triptorelin) was administered three days after transfer and group 2 (n=100) ,who did not receive agonist.Both groups received daily vaginal progesterone suppositories(800 mg daily) plus estradiol valerate( 6 mg dai-ly)
Patients were administered estradiol valerate 6 milligrams daily and ASA 80 mg from day 2 of the cycle.vaginal sonography eas done on day ; since the endometrial thickness reached 8 mm,daily vaginal progesterone suppositories(total dose 800 mg daily) was administered . Randomization was done on the day of embryo transfer by a computer-generated table.Blindness was done for researchers.Patients were divided to group 1(n=100) to whom a single dose of GnRH agonist( 0.1 mg triptorelin) was administered three days after transfer and group 2 (n=100) ,who did not receive agonist.Both groups received daily vaginal progesterone suppositories(800 mg daily) plus estradiol valerate( 6 mg dai-ly)
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به بیماران از روز دوم سیکل قاعدگی روزانه 6 میلی گرم استرادیول خوراکی داده می شودر روز 12 سیکل، بیماران سونوگرافی می شوند. پس از رسیدن ضخامت اندومتر به 8 میلی متر یا بیشتر پروژسترون 800 میلی گرم روزانه تجویز شده و سپس انتقال جنین برگشت از فریزدر مرحله Cleavage صورت می گیرد.در روز انتقال، بیماران به صورت تصادفی بر اساس جدول اعداد کامپیوتری به دو گروه تقسیم می شوندکورسازی برای اندازه گیری کنندگان پیامدهای مطالعه ( پژوهشگران)انجام شده،یک گروه سه روز بعد از انتقال،یک عدد آمپول دکاپپتیل 0.1 میلی گرمی(Triptorelin 0.1 (زیرجلدی دریافت خواهند کرد و گروه دیگر دارو نخواهند گرفت.به هر دو گروه شیاف پروژسترون واژینال (800 میلی گرم روزانه) و قرص استرادیول والرات(6 میلی گرم روزانه)داده می شود
به بیماران از روز دوم سیکل قاعدگی روزانه 6 میلی گرم استرادیول خوراکی داده می شودر روز 12 سیکل، بیماران سونوگرافی می شوند. پس از رسیدن ضخامت اندومتر به 8 میلی متر یا بیشتر پروژسترون 800 میلی گرم روزانه تجویز شده و سپس انتقال جنین برگشت از فریزدر مرحله Cleavage صورت می گیرد.در روز انتقال، بیماران به صورت تصادفی بر اساس جدول اعداد کامپیوتری به دو گروه تقسیم می شوندکورسازی برای اندازه گیری کنندگان پیامدهای مطالعه ( پژوهشگران)انجام شده،یک گروه سه روز بعد از انتقال،یک عدد آمپول دکاپپتیل 0.1 میلی گرمی(Triptorelin 0.1 (زیرجلدی دریافت خواهند کرد و گروه دیگر دارو نخواهند گرفت.به هر دو گروه شیاف پروژسترون واژینال (800 میلی گرم روزانه) و قرص استرادیول والرات(6 میلی گرم روزانه)داده می شود
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Inclusion criteria:patients in frozen-thawed embryo transfer cycle who have freezed embryo due to previous OHSS or supernumerary freezed embryos
age of 18 to 40years;exclusion:patients below the age of 18 and over 40 years;oocyte recipients; patients who had systemic or endocrine disorders ; submucous fibroids or intrauterine adhesions with or without history of previous surgery
Inclusion criteria:patients in frozen-thawed embryo transfer cycle who have freezed embryo due to previous OHSS or supernumerary freezed embryos age of 18 to 40years;exclusion:patients below the age of 18 and over 40 years;oocyte recipients; patients who had systemic or endocrine disorders ; submucous fibroids or intrauterine adhesions with or without history of previous surgery
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ورود به مطالعه: بیماران دارای جنین فریز شده در سیکل های قبلی یا به علت خطر OHSS وشرایط یا به علت وجود جنین های اضافی؛ سن بین 18 تا 40 سال;
شرایط خروج از مطالعه:سن زیر 18 یا بالای 40,د؛ ؛ اندومتریوز ؛
ریافت کنندگان اووسیت اهدایی
سابقه بیماری های سیستمیک یا اندوکرین
فیبروم های ساب موکوز یا چسبندگی داخل رحمی
با یا بدون عمل جراحی قبلی
ورود به مطالعه: بیماران دارای جنین فریز شده در سیکل های قبلی یا به علت خطر OHSS وشرایط یا به علت وجود جنین های اضافی؛ سن بین 18 تا 40 سال; شرایط خروج از مطالعه:سن زیر 18 یا بالای 40,د؛ ؛ اندومتریوز ؛ ریافت کنندگان اووسیت اهدایی سابقه بیماری های سیستمیک یا اندوکرین فیبروم های ساب موکوز یا چسبندگی داخل رحمی با یا بدون عمل جراحی قبلی
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patients in frozen-thawed embryo transfer cycle
patients in frozen-thawed embryo transfer cycle
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بیماران دارای جنین فریز شده در سیکل های قبلی
بیماران دارای جنین فریز شده در سیکل های قبلی
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primary outcome measure was clinical pregnancy rate.secondary outcome measures were implantation rate,chemical ,ongoing pregnancy rate and abortion rate .
primary outcome measure was clinical pregnancy rate.secondary outcome measures were implantation rate,chemical ,ongoing pregnancy rate and abortion rate .
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پیامد اولیه میزان حاملگی شیمیایی است.پیامد ثانویه ،implantation rateو میزان حاملگی شیمیایی،ongoing pregnancy rate و میزان سقط خواهد بود.
پیامد اولیه میزان حاملگی شیمیایی است.پیامد ثانویه ،implantation rateو میزان حاملگی شیمیایی،ongoing pregnancy rate و میزان سقط خواهد بود.
General information
17
18
1718
1
1
1
1
200
221
200221
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200
200
2014-01-21, 1392/11/01
2014-04-03, 1393/01/14
2014-0104-2103 00:00:00
2015-01-21, 1393/11/01
2015-01-20, 1393/10/30
2015-01-2120 00:00:00
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2014-04-03, 1393/01/14
2014-04-03 00:00:00
empty
2015-01-01, 1393/10/11
2015-01-01 00:00:00
empty
2015-01-01, 1393/10/11
2015-01-01 00:00:00
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defect in previous data
defect in previous data
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نقص اطلاعات قبلی
نقص اطلاعات قبلی
patients in frozen-thawed embryo transfer cycle who have freezed embryo due to previous OHSS or supernumerary freezed embryos
age of 18 to 40years
patients in frozen-thawed embryo transfer cycle who have freezed embryo due to previous OHSS or supernumerary freezed embryos age of 18 to 40years
بیماران دارای جنین فریز شده در سیکل های قبلی یا به علت خطر OHSS وشرایط یا به علت وجود جنین های اضافی
سن بین ۱۸ تا ۴۰ سال
بیماران دارای جنین فریز شده در سیکل های قبلی یا به علت خطر OHSS وشرایط یا به علت وجود جنین های اضافی سن بین ۱۸ تا ۴۰ سال
patients below the age of 18 and over 40 years, , , endometriosis,
oocyte recipients
patients who had systemic or endocrine disorders such as diabetes mellitus and thyroid disorders
submucous fibroids or intrauterine adhesions
with or without history of previous surgery
patients below the age of 18 and over 40 years, , , endometriosis, oocyte recipients patients who had systemic or endocrine disorders such as diabetes mellitus and thyroid disorders submucous fibroids or intrauterine adhesions with or without history of previous surgery
شرایط خروج از مطالعه:سن زیر 18 یا بالای 40,د؛ ؛ اندومتریوز ؛
ریافت کنندگان اووسیت اهدایی
سابقه بیماری های سیستمیک یا اندوکرین
فیبروم های ساب موکوز یا چسبندگی داخل رحمی
با یا بدون عمل جراحی قبلی؛
شرایط خروج از مطالعه:سن زیر 18 یا بالای 40,د؛ ؛ اندومتریوز ؛ ریافت کنندگان اووسیت اهدایی سابقه بیماری های سیستمیک یا اندوکرین فیبروم های ساب موکوز یا چسبندگی داخل رحمی با یا بدون عمل جراحی قبلی؛
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simple, randomization table
simple, randomization table
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ساده .جدول اعداد تصادفی
ساده .جدول اعداد تصادفی
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participants, data evaluators
participants, data evaluators
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شرکت کنندگان و کسانی که پیامد را ارزیابی می کنند
شرکت کنندگان و کسانی که پیامد را ارزیابی می کنند
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Recruitment centers
#1
Name of recruitment center - English: Yazd reserch and clinical center for infertility
Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: abbas aflatoonian
Full name of responsible person - Persian: عباس افلاطونیان
Street address - English: Bouali Avenue, Safayeh
Street address - Persian: صفاییه، خیابان بو علی
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: Yazd reserch and clinical center for infertility
Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: abbas aflatoonian
Full name of responsible person - Persian: عباس افلاطونیان
Street address - English: Bouali Avenue, Safayeh
Street address - Persian: صفاییه، خیابان بو علی
City - English: yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 15898
Phone: +98 35 3824 3182
Fax:
Email: m_fmojtahedi@yahoo.com
Web page address:
Name of recruitment center - English: Yazd reserch and clinical center for infertility Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد Full name of responsible person - English: abbas aflatoonian Full name of responsible person - Persian: عباس افلاطونیان Street address - English: Bouali Avenue, Safayeh Street address - Persian: صفاییه، خیابان بو علی City - English: yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 15898 Phone: +98 35 3824 3182 Fax: Email: m_fmojtahedi@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Yazd Research and Clinical center for infertility
Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Alimohammad Abdoli
Full name of responsible person - Persian: علی محمد عبدلی
Street address - English: Bouali Avenue, Safayeh
Street address - Persian: صفاییه، خیابان بو علی
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: Yazd Research and Clinical center for infertility
Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Alimohammad Abdoli
Full name of responsible person - Persian: علی محمد عبدلی
Street address - English: Bouali Avenue, Safayeh
Street address - Persian: صفاییه، خیابان بو علی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 1824 7085
Fax: +98 35 3824 7087
Email: info@yazd-rsi.ir
Web page address: http://ssu.ac.ir/cms
contact.organization_id: Name of organization / entity - English: Yazd Research and Clinical center for infertility Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد Full name of responsible person - English: Alimohammad Abdoli Full name of responsible person - Persian: علی محمد عبدلی Street address - English: Bouali Avenue, Safayeh Street address - Persian: صفاییه، خیابان بو علی City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 1824 7085 Fax: +98 35 3824 7087 Email: info@yazd-rsi.ir Web page address: http://ssu.ac.ir/cms
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Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Yazd Reserch and Clinical center for infertility
Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Dr.Robab Davar
Full name of responsible person - Persian: دکتر رباب داور
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bouali Avenue, Safayeh
Street address - Persian: صفاییه، خیابان بو علی
City - English: Yazd
City - Persian: یزد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Mobile: +98 913 151 0762
Fax:
Email: r_davar@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Yazd Reserch and Clinical center for infertility
Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Dr.Robab Davar
Full name of responsible person - Persian: دکتر رباب داور
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bouali Avenue, Safayeh
Street address - Persian: صفاییه، خیابان بو علی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Mobile: +98 913 151 0762
Fax:
Email: r_davar@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Yazd Reserch and Clinical center for infertility Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد Full name of responsible person - English: Dr.Robab Davar Full name of responsible person - Persian: دکتر رباب داور Position - English: Associate professor Position - Persian: دانشیار 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 Avenue, Safayeh Street address - Persian: صفاییه، خیابان بو علی City - English: Yazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Mobile: +98 913 151 0762 Fax: Email: r_davar@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Yazd Reaserch and Clinical Center for infertility
Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Dr. Maryam faridMojtahedi
Full name of responsible person - Persian: دکتر مریم فرید مجتهدی
Position - English: Fellowship of infertility
Position - Persian: فلوشیپ نازایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bouali Avenue, Safayeh
Street address - Persian: صفاییه، خیابان بو علی
City - English: Yazd
City - Persian: یزد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Mobile: +98 912 123 0934
Fax:
Email: m_fmojtahedi@ssu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Yazd Reaserch and Clinical Center for infertility
Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Dr. Maryam faridMojtahedi
Full name of responsible person - Persian: دکتر مریم فرید مجتهدی
Position - English: Fellowship of infertility
Position - Persian: فلوشیپ 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: Bouali Avenue, Safayeh
Street address - Persian: صفاییه، خیابان بو علی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Mobile: +98 912 123 0934
Fax:
Email: m_fmojtahedi@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Yazd Reaserch and Clinical Center for infertility Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد Full name of responsible person - English: Dr. Maryam faridMojtahedi Full name of responsible person - Persian: دکتر مریم فرید مجتهدی Position - English: Fellowship of infertility Position - Persian: فلوشیپ 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 Avenue, Safayeh Street address - Persian: صفاییه، خیابان بو علی City - English: Yazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Mobile: +98 912 123 0934 Fax: Email: m_fmojtahedi@ssu.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Yazd Reaserch and Clinical Center for infertility
Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Dr.Robab Davar
Full name of responsible person - Persian: دکتر رباب داور
Position - English: Assoiate Professor
Position - Persian: دانشیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bouali Avenue, Safayeh
Street address - Persian: صفاییه، خیابان بوعلی
City - English: Yazd
City - Persian: یزد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Mobile: +98 913 151 0762
Fax:
Email: r_davar@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Yazd Reaserch and Clinical Center for infertility
Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Dr.Robab Davar
Full name of responsible person - Persian: دکتر رباب داور
Position - English: Assoiate Professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bouali Avenue, Safayeh
Street address - Persian: صفاییه، خیابان بوعلی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Mobile: +98 913 151 0762
Fax:
Email: r_davar@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Yazd Reaserch and Clinical Center for infertility Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد Full name of responsible person - English: Dr.Robab Davar Full name of responsible person - Persian: دکتر رباب داور Position - English: Assoiate Professor Position - Persian: دانشیار Latest degree: sub_specialist Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Bouali Avenue, Safayeh Street address - Persian: صفاییه، خیابان بوعلی City - English: Yazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Mobile: +98 913 151 0762 Fax: Email: r_davar@yahoo.com Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
empty
only some data like main outcomes can be shared.
only some data like main outcomes can be shared.
empty
فقط بخشی ازداده نظیر اطلاعات مربوط به پیامد اصلی امکان اشتراک گذاری دارد.
فقط بخشی ازداده نظیر اطلاعات مربوط به پیامد اصلی امکان اشتراک گذاری دارد.
empty
from 1395
from 1395
empty
از سال ۹۵
از سال ۹۵
empty
academic and scientific researchers
academic and scientific researchers
empty
محققین شاغل در موسسات دانشگاهی و علمی
محققین شاغل در موسسات دانشگاهی و علمی
empty
no specific circumstances
no specific circumstances
empty
شرایط خاصی ندارد
شرایط خاصی ندارد
empty
m_fmojtahedi@yahoo.com
maryam farid Mojtahedi
m_fmojtahedi@yahoo.com maryam farid Mojtahedi
empty
m_fmojtahedi@yahoo.com,مریم فرید مجتهدی
m_fmojtahedi@yahoo.com,مریم فرید مجتهدی
empty
by e-mail
by e-mail
empty
ایمیل بزنند
ایمیل بزنند
Protocol summary
Study aim
the additional GnRH agonist administered at the time of implantation for luteal phase support in FET cycles improves the pregnancy outcome in frozen-thawed embryo transfer cycles (FET) cycles
Design
prospective parallel single blind controlled trial on 200 patients.for randomization was computerized with randomization table
Settings and conduct
Patients were administered estradiol valerate 6 milligrams daily and ASA 80 mg from day 2 of the cycle.vaginal sonography eas done on day ; since the endometrial thickness reached 8 mm,daily vaginal progesterone suppositories(total dose 800 mg daily) was administered . Randomization was done on the day of embryo transfer by a computer-generated table.Blindness was done for researchers.Patients were divided to group 1(n=100) to whom a single dose of GnRH agonist( 0.1 mg triptorelin) was administered three days after transfer and group 2 (n=100) ,who did not receive agonist.Both groups received daily vaginal progesterone suppositories(800 mg daily) plus estradiol valerate( 6 mg dai-ly)
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients in frozen-thawed embryo transfer cycle who have freezed embryo due to previous OHSS or supernumerary freezed embryos
age of 18 to 40years;exclusion:patients below the age of 18 and over 40 years;oocyte recipients; patients who had systemic or endocrine disorders ; submucous fibroids or intrauterine adhesions with or without history of previous surgery
Intervention groups
patients in frozen-thawed embryo transfer cycle
Main outcome variables
primary outcome measure was clinical pregnancy rate.secondary outcome measures were implantation rate,chemical ,ongoing pregnancy rate and abortion rate .
General information
Reason for update
defect in previous data
Acronym
IRCT registration information
IRCT registration number:IRCT2015031021420N1
Registration date:2015-04-12, 1394/01/23
Registration timing:retrospective
Last update:2021-03-08, 1399/12/18
Update count:1
Registration date
2015-04-12, 1394/01/23
Registrant information
Name
Maryam Farid Mojtahedi
Name of organization / entity
Arash women hospital,clinic for infertility,Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 8755
Email address
m_fmojtahedi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yazd University of Medical Sciences
Expected recruitment start date
2014-04-03, 1393/01/14
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
2014-04-03, 1393/01/14
Actual recruitment end date
2015-01-01, 1393/10/11
Trial completion date
2015-01-01, 1393/10/11
Scientific title
Effect of single dose of GnRH-agonist on pregnancy outcome in frozen-thawed embryo transfer cycles
Public title
GnRH agonist administration in assisted reproductive program
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients in frozen-thawed embryo transfer cycle who have freezed embryo due to previous OHSS or supernumerary freezed embryos
age of 18 to 40years
Exclusion criteria:
patients below the age of 18 and over 40 years, , , endometriosis,
oocyte recipients
patients who had systemic or endocrine disorders such as diabetes mellitus and thyroid disorders
submucous fibroids or intrauterine adhesions
with or without history of previous surgery
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
221
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
simple, randomization table
Blinding (investigator's opinion)
Single blinded
Blinding description
participants, data evaluators
Placebo
Not used
Assignment
Parallel
Other design features
A computer-generated randomization table was created for
the study population .Allocation concealment was ensured by the use of sealed envelopes on the day of embryo transfer
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitee of Shahid Sadoughi University of Medical Sciences
Street address
Bouali Ave, Safaeyeh
City
yazd
Province
Yazd
Postal code
8916877391
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
314
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
clinical pregnancy
Timepoint
28 days after transfer
Method of measurement
vaginal sonography
Secondary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after transfer
Method of measurement
BHCG test
Intervention groups
1
Description
intervention group:a single dose of GnRH agonist( 0.1 mg triptorelin) was administered three days after transfer
Category
Treatment - Drugs
2
Description
Control group do not receive triptoreline0.1mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd reserch and clinical center for infertility
Full name of responsible person
abbas aflatoonian
Street address
Bouali Avenue, Safayeh
City
yazd
Province
Yazd
Postal code
15898
Phone
+98 35 3824 3182
Email
m_fmojtahedi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Research and Clinical center for infertility
Full name of responsible person
Alimohammad Abdoli
Street address
Bouali Avenue, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 3824 7087
Email
info@yazd-rsi.ir
Web page address
http://ssu.ac.ir/cms
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Research and Clinical center for infertility
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
Yazd Reserch and Clinical center for infertility
Full name of responsible person
Dr.Robab Davar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Avenue, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
r_davar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Reaserch and Clinical Center for infertility
Full name of responsible person
Dr. Maryam faridMojtahedi
Position
Fellowship of infertility
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Avenue, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
m_fmojtahedi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Reaserch and Clinical Center for infertility
Full name of responsible person
Dr.Robab Davar
Position
Assoiate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
r_davar@yahoo.com
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
only some data like main outcomes can be shared.
When the data will become available and for how long
from 1395
To whom data/document is available
academic and scientific researchers
Under which criteria data/document could be used
no specific circumstances
From where data/document is obtainable
m_fmojtahedi@yahoo.com
maryam farid Mojtahedi
What processes are involved for a request to access data/document