A comparison of Dual triggering by administration of Gonadotropin releasing hormon agonist plus human chorionic gonadotropin versus HCG in normal responders at assisted reproductive programs outcome
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Protocol summary
The aim of this study was to evaluate the effect of dual triggering in Art outcome.210 patients began ovarian stimulation with a flexible starting
dosage of recombinant FSH (Gonal-F; Merck Serono .)
ranging from 150 to 225 IU on the second day of the menstrual cycle for 5 consecutive days. Once the leading follicle had reached a size of 13 mm,
co-treatment with the GnRH antagonist 0.25 mg/day, was initiated. Gonadotropins doses were further adjusted according to vaginal ultrasound measurements of follicular diameter,obtained every two or three days. When at least two leading follicles had reached 17 mm in diameter, final oocyte maturation was
triggered by either 6500 I.U. hCG alone, or by 6500 IU hCG plus 0.2 mg of triptorelin (Decapeptyl; Ferring GmbH).Oocyte retrievals were performed under transvaginal ultrasound guidance 34 to 36 hours after triggering. All embryo transfers were performed 48 to72 hours after oocyte retrieval.
The luteal phase was supported by daily progesterone suppositories(total dose 800mg) starting on the day of oocyte retrieval. Serum b-hCG was measured 14 days after transfer, and a value above 5 IU/mL was considered
to be a positive pregnancy. The luteal support was then
continued until the 10th week of gestation.The primary outcome measure was clinical pregnancy rate and the secondary outcome measures were implantation rate,chemical pregnancy , ongoing pregnancy ,OHSS rate andf abortion rate.
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The aim of this study was to evaluate the effect of dual triggering in Art outcome.210 patients began ovarian stimulation with a flexible starting dosage of recombinant FSH (Gonal-F; Merck Serono .) ranging from 150 to 225 IU on the second day of the menstrual cycle for 5 consecutive days. Once the leading follicle had reached a size of 13 mm, co-treatment with the GnRH antagonist 0.25 mg/day, was initiated. Gonadotropins doses were further adjusted according to vaginal ultrasound measurements of follicular diameter,obtained every two or three days. When at least two leading follicles had reached 17 mm in diameter, final oocyte maturation was triggered by either 6500 I.U. hCG alone, or by 6500 IU hCG plus 0.2 mg of triptorelin (Decapeptyl; Ferring GmbH).Oocyte retrievals were performed under transvaginal ultrasound guidance 34 to 36 hours after triggering. All embryo transfers were performed 48 to72 hours after oocyte retrieval. The luteal phase was supported by daily progesterone suppositories(total dose 800mg) starting on the day of oocyte retrieval. Serum b-hCG was measured 14 days after transfer, and a value above 5 IU/mL was considered to be a positive pregnancy. The luteal support was then continued until the 10th week of gestation.The primary outcome measure was clinical pregnancy rate and the secondary outcome measures were implantation rate,chemical pregnancy , ongoing pregnancy ,OHSS rate andf abortion rate.
هدف این مطالعه بررسی اثر dual triggering بر نتایج برنامه های کمک باروری است. به 210 بیمار از روز دوم سیکل به صورت flexible روزانه 150 تا 225 واحد گنادوتروپین (GonalF یا fostimon) تجویز شده بعد از 5 روز از تجویز به صورت متوالی سونوگرافی می شوند،با پدیدار شدن یک فولیکول با قطر 13 میلی متر ،آنتاگونیست (cetrotide0.25) شروع میشود.دوز گنادوتروپین بر اساس پاسخ تخمدانی بیمار با اندازه گیری سایز فولیکولها هر 2-3 روز یکبار تنظیم می شود. وسپس بیمارانی که در روز تریگرینگ دارای حداقل دو فولیکول بالای 17 میلی متر داشته باشند انتخاب شده به صورت تصادفی به دو گروه تقسیم می شوند؛ یک گروه با HCG6500 I.U و آگونیستGnRH (triptorelin 0.2mg) و گروه کنترل با HCG6500 I.U ،Trigger خواهند شد.سپس 34-36 ساعت بعد پونکسیون تحت گاید سونوگرافی انجام خواهد شد. انتقال تمامی جنینها 48 تا 72 ساعت بعد از پونکسیون صورت خواهد گرفت. ساپورت لوتئال با شیاف پروزسترون با دوز کلی 800 میلیگرم روزانه که از روز پونکسیون شروع می شود انجام می شود.BhCG سرم 14 روز بعد از انتقال سنجیده شده و مقدار بالای 5 واحد مثبت در نظر گرفته می شود.سپس ساپورت لوتئال تا 10 هفتگی ادامه می شود.پیامد درمانی اولیه ،میزان حاملگی کلینیکی و پیامد ثانویه میزان implantation،حاملگی کلینیکی و ongoing،میزان OHSS و میزان سقط است.
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هدف این مطالعه بررسی اثر dual triggering بر نتایج برنامه های کمک باروری است. به 210 بیمار از روز دوم سیکل به صورت flexible روزانه 150 تا 225 واحد گنادوتروپین (GonalF یا fostimon) تجویز شده بعد از 5 روز از تجویز به صورت متوالی سونوگرافی می شوند،با پدیدار شدن یک فولیکول با قطر 13 میلی متر ،آنتاگونیست (cetrotide0.25) شروع میشود.دوز گنادوتروپین بر اساس پاسخ تخمدانی بیمار با اندازه گیری سایز فولیکولها هر 2-3 روز یکبار تنظیم می شود. وسپس بیمارانی که در روز تریگرینگ دارای حداقل دو فولیکول بالای 17 میلی متر داشته باشند انتخاب شده به صورت تصادفی به دو گروه تقسیم می شوند؛ یک گروه با HCG6500 I.U و آگونیستGnRH (triptorelin 0.2mg) و گروه کنترل با HCG6500 I.U ،Trigger خواهند شد.سپس 34-36 ساعت بعد پونکسیون تحت گاید سونوگرافی انجام خواهد شد. انتقال تمامی جنینها 48 تا 72 ساعت بعد از پونکسیون صورت خواهد گرفت. ساپورت لوتئال با شیاف پروزسترون با دوز کلی 800 میلیگرم روزانه که از روز پونکسیون شروع می شود انجام می شود.BhCG سرم 14 روز بعد از انتقال سنجیده شده و مقدار بالای 5 واحد مثبت در نظر گرفته می شود.سپس ساپورت لوتئال تا 10 هفتگی ادامه می شود.پیامد درمانی اولیه ،میزان حاملگی کلینیکی و پیامد ثانویه میزان implantation،حاملگی کلینیکی و ongoing،میزان OHSS و میزان سقط است.
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evaluation of dual triggering for final oocyte maturation with a single dose of GnRH-a and a standard dose of hCG in GnRH-antagonist IVF/ Intracytoplasmic sperm injection (ICSI) cycles in normal responders.
evaluation of dual triggering for final oocyte maturation with a single dose of GnRH-a and a standard dose of hCG in GnRH-antagonist IVF/ Intracytoplasmic sperm injection (ICSI) cycles in normal responders.
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ارزیابی تحریک دوگانه برای بلوغ نهایی تخمک با یک دوز واحد GnRH-a و یک دوز استاندارد hCG در چرخه های تزریق اسپرم (ICSI) IVF / آنتاگونیست GnRH در پاسخ دهندگان طبیعی
ارزیابی تحریک دوگانه برای بلوغ نهایی تخمک با یک دوز واحد GnRH-a و یک دوز استاندارد hCG در چرخه های تزریق اسپرم (ICSI) IVF / آنتاگونیست GnRH در پاسخ دهندگان طبیعی
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The study was a phase 2 trial. Randomization was performed based on a table of computer random numbers.
The study was a phase 2 trial. Randomization was performed based on a table of computer random numbers.
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مطالعه کارآزمایی فاز 2 بود . تصادفی سازی بر اساس جدول اعداد تصادفی کامپوتری انجام شد.
مطالعه کارآزمایی فاز 2 بود . تصادفی سازی بر اساس جدول اعداد تصادفی کامپوتری انجام شد.
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The study was conducted at Yazd Infertility Research Center.The study was one-sided blind .
The study was conducted at Yazd Infertility Research Center.The study was one-sided blind .
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مطالعه در مرکز تحقیقات ناباروری یزد انجام شد.مطالعه یک سو کور بود .
مطالعه در مرکز تحقیقات ناباروری یزد انجام شد.مطالعه یک سو کور بود .
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The inclusion criteria were 18< Body mass index <30 kg/m2, and age ≤42 yr with the history of infertility for at least 1 yr that were candidate for ART protocol. Our exclusion criteria were the presence of endocrine disorders such as diabetes mellitus, hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, Cushing syndrome, polycystic ovary syndrome, congenital uterine anomaliesdisorders, repeated implantation failure, day-3 FSH concentration ≥10 IU/L or serum anti-Mullerian hormone ≤1.0 ng/mL, and azoospermia.
The inclusion criteria were 18< Body mass index <30 kg/m2, and age ≤42 yr with the history of infertility for at least 1 yr that were candidate for ART protocol. Our exclusion criteria were the presence of endocrine disorders such as diabetes mellitus, hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, Cushing syndrome, polycystic ovary syndrome, congenital uterine anomaliesdisorders, repeated implantation failure, day-3 FSH concentration ≥10 IU/L or serum anti-Mullerian hormone ≤1.0 ng/mL, and azoospermia.
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معیارهای ورود 18 <شاخص توده بدنی <30 کیلوگرم در متر مربع و سن ≤42 سال با سابقه ناباروری حداقل 1 سال که کاندید پروتکل ART بودند. معیارهای خروج ما وجود اختلالات غدد درون ریز مانند دیابت شیرین ، هایپراپلاکتینمی ، اختلالات تیروئید ، هیپرپلازی مادرزادی آدرنال ، سندرم کوشینگ ، سندرم تخمدان پلی کیستیک ، ناهنجاری های مادرزادی رحم ، نارسایی مکرر لانه گزینی ، غلظت روزانه 3 FSH ≥10 IU / L یا سرم بود. هورمون ضد مولری ≤.0 ng / mL و آزواسپرمی
معیارهای ورود 18 <شاخص توده بدنی <30 کیلوگرم در متر مربع و سن ≤42 سال با سابقه ناباروری حداقل 1 سال که کاندید پروتکل ART بودند. معیارهای خروج ما وجود اختلالات غدد درون ریز مانند دیابت شیرین ، هایپراپلاکتینمی ، اختلالات تیروئید ، هیپرپلازی مادرزادی آدرنال ، سندرم کوشینگ ، سندرم تخمدان پلی کیستیک ، ناهنجاری های مادرزادی رحم ، نارسایی مکرر لانه گزینی ، غلظت روزانه 3 FSH ≥10 IU / L یا سرم بود. هورمون ضد مولری ≤.0 ng / mL و آزواسپرمی
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patients began ovarian stimulation with a flexible starting dosage of recombinant FSH ranging from 150 to 225 IU on the second day of the menstrual cycle for 5 consecutive days. Once the leading follicle had reached a size of 13 mm, co-treatment with the GnRH antagonist 0.25 mg/day, was initiated. When at least two leading follicles had reached 17 mm in diameter, final oocyte maturation was triggered by either 6500 I.U. hCG alone, or by 6500 IU hCG plus 0.2 mg of triptorelin (Decapeptyl; Ferring GmbH).Oocyte retrievals were performed under transvaginal ultrasound guidance 34 to 36 hours after triggering.
patients began ovarian stimulation with a flexible starting dosage of recombinant FSH ranging from 150 to 225 IU on the second day of the menstrual cycle for 5 consecutive days. Once the leading follicle had reached a size of 13 mm, co-treatment with the GnRH antagonist 0.25 mg/day, was initiated. When at least two leading follicles had reached 17 mm in diameter, final oocyte maturation was triggered by either 6500 I.U. hCG alone, or by 6500 IU hCG plus 0.2 mg of triptorelin (Decapeptyl; Ferring GmbH).Oocyte retrievals were performed under transvaginal ultrasound guidance 34 to 36 hours after triggering.
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به بیماران از روز دوم سیکل به صورت flexible روزانه 150 تا 225 واحد گنادوتروپین تجویز شده بعد از 5 روز از تجویز به صورت متوالی سونوگرافی می شوند،با پدیدار شدن یک فولیکول با قطر 13 میلی متر ،آنتاگونیست (cetrotide0.25) شروع میشود.سپس بیمارانی که در روز تریگرینگ دارای حداقل دو فولیکول بالای 17 میلی متر داشته باشند انتخاب شده به صورت تصادفی به دو گروه تقسیم می شوند؛ یک گروه با HCG6500 I.U و آگونیستGnRH (triptorelin 0.2mg) و گروه کنترل با HCG6500 I.U ،Trigger خواهند شد.سپس 34-36 ساعت بعد پونکسیون تحت گاید سونوگرافی انجام خواهد شد.
به بیماران از روز دوم سیکل به صورت flexible روزانه 150 تا 225 واحد گنادوتروپین تجویز شده بعد از 5 روز از تجویز به صورت متوالی سونوگرافی می شوند،با پدیدار شدن یک فولیکول با قطر 13 میلی متر ،آنتاگونیست (cetrotide0.25) شروع میشود.سپس بیمارانی که در روز تریگرینگ دارای حداقل دو فولیکول بالای 17 میلی متر داشته باشند انتخاب شده به صورت تصادفی به دو گروه تقسیم می شوند؛ یک گروه با HCG6500 I.U و آگونیستGnRH (triptorelin 0.2mg) و گروه کنترل با HCG6500 I.U ،Trigger خواهند شد.سپس 34-36 ساعت بعد پونکسیون تحت گاید سونوگرافی انجام خواهد شد.
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The primary outcome measure was clinical pregnancy rate and the secondary outcome measures were implantation rate,chemical pregnancy , ongoing pregnancy ,OHSS rate and abortion rate.
The primary outcome measure was clinical pregnancy rate and the secondary outcome measures were implantation rate,chemical pregnancy , ongoing pregnancy ,OHSS rate and abortion rate.
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پیامد درمانی اولیه ،میزان حاملگی کلینیکی و پیامد ثانویه میزان implantation،حاملگی کلینیکی و ongoing،میزان OHSS و میزان سقط است.
پیامد درمانی اولیه ،میزان حاملگی کلینیکی و پیامد ثانویه میزان implantation،حاملگی کلینیکی و ongoing،میزان OHSS و میزان سقط است.
General information
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1
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210
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210192
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2015-04-19, 1394/01/30
2014-06-20, 1393/03/30
20152014-0406-1920 00:00:00
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2014-03-21, 1393/01/01
2014-03-21 00:00:00
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2015-02-01, 1393/11/12
2015-02-01 00:00:00
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2015-03-02, 1393/12/11
2015-03-02 00:00:00
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Updating the trial according to the last changes in methods and adding results
Updating the trial according to the last changes in methods and adding results
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به روز رسانی کارازمایی بالینی بر اساس آخرین تغییرات و اضافه کردن نتایج
به روز رسانی کارازمایی بالینی بر اساس آخرین تغییرات و اضافه کردن نتایج
normal responder women by tubal or male infertility factor, 18< Body mass index <30 kg/m2, and age ≤42 yr with the history of infertility for at least 1 yr that were candidate for ART protocol
normal responder women by tubal or male infertility factor, 18< Body mass index <30 kg/m2, and age ≤42 yr with the history of infertility for at least 1 yr that were candidate for ART protocol
زنان پاسخ دهنده طبیعی توسط فاکتور ناباروری لوله ای یا مردانه , 18 <شاخص توده بدنی <30 کیلوگرم در متر مربع و سن ≤42 سال با سابقه ناباروری حداقل 1 سال که کاندید پروتکل ART بودند
زنان پاسخ دهنده طبیعی توسط فاکتور ناباروری لوله ای یا مردانه , 18 <شاخص توده بدنی <30 کیلوگرم در متر مربع و سن ≤42 سال با سابقه ناباروری حداقل 1 سال که کاندید پروتکل ART بودند
the presence of endocrine disorders such as diabetes mellitus, hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, Cushing syndrome, polycystic ovary syndrome, congenital uterine anomaliesdisorders, repeated implantation failure, day-3 FSH concentration ≥10 IU/L or serum anti-Mullerian hormone ≤1.0 ng/mL, and azoospermia
the presence of endocrine disorders such as diabetes mellitus, hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, Cushing syndrome, polycystic ovary syndrome, congenital uterine anomaliesdisorders, repeated implantation failure, day-3 FSH concentration ≥10 IU/L or serum anti-Mullerian hormone ≤1.0 ng/mL, and azoospermia
وجود اختلالات غدد درون ریز مانند دیابت شیرین ، هایپر پرولاکتینمی ، اختلالات تیروئید ، هیپرپلازی مادرزادی آدرنال ، سندرم کوشینگ ، سندرم تخمدان پلی کیستیک ، ناهنجاری های مادرزادی رحم ، نارسایی مکرر لانه گزینی ، غلظت روزانه 3 FSH ≥10 IU / L یا هورمون سرم ضد مولری ng.0 نانوگرم در میلی لیتر و آزواسپرمی
وجود اختلالات غدد درون ریز مانند دیابت شیرین ، هایپر پرولاکتینمی ، اختلالات تیروئید ، هیپرپلازی مادرزادی آدرنال ، سندرم کوشینگ ، سندرم تخمدان پلی کیستیک ، ناهنجاری های مادرزادی رحم ، نارسایی مکرر لانه گزینی ، غلظت روزانه 3 FSH ≥10 IU / L یا هورمون سرم ضد مولری ng.0 نانوگرم در میلی لیتر و آزواسپرمی
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randomization was done by table of random numbers
randomization was done by table of random numbers
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تصادفی سازی با استفاده از جدول اعداد تصادفی انجام شد.
تصادفی سازی با استفاده از جدول اعداد تصادفی انجام شد.
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Patients were named as groups 1 and 2. And the statistical analyzer did not know the type of treatment protocol used in each group.
Patients were named as groups 1 and 2. And the statistical analyzer did not know the type of treatment protocol used in each group.
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بیماران بصورت گروه 1 و 2 نامگذاری شدند.و انالیزور امار اطلاعی از نوع پروتکل درمانی استفاده شده در هر گروه نداشت.
بیماران بصورت گروه 1 و 2 نامگذاری شدند.و انالیزور امار اطلاعی از نوع پروتکل درمانی استفاده شده در هر گروه نداشت.
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Recruitment centers
#1
Name of recruitment center - English: Bouali Avenue, Safayeh
Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری
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: Bouali Avenue, Safayeh
Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری
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: 8916977443
Phone: +98 35 3824 7085
Fax:
Email: aflatoonian @ssu.ac.ir
Web page address:
Name of recruitment center - English: Bouali Avenue, Safayeh Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری 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: 8916977443 Phone: +98 35 3824 7085 Fax: Email: aflatoonian @ssu.ac.ir Web page address:
Sponsors / Funding sources
#1
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
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 بوعلی
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: shahid sadoughi university of medical sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید صدوقی
Full name of responsible person - English: masood mirzaee
Full name of responsible person - Persian: مسعود میرزایی
Street address - English: bahonar Avenue,
Street address - Persian: خیابان باهنر
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916978477
Phone: +98 35 3726 3732
Fax:
Email: masood_mirzaei@hotmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Yazd reaserch and clinical center for infertilityshahid sadoughi university of medical sciences Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروریدانشگاه علوم پزشکی شهید صدوقی Full name of responsible person - English: Alimohammad Abdolimasood mirzaee Full name of responsible person - Persian: علی محمد عبدلیمسعود میرزایی Street address - English: Boualibahonar Avenue, Safayeh Street address - Persian: صفاییه، خیابان بوعلیباهنر City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8916978477 Phone: +98 35 3726 3732 Fax: Email: masood_mirzaei@hotmail.com Web page address:
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Public
public
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Domestic
domestic
empty
Academic
academic
Yazd reaserch and clinical center for infertility
shahid sadoughi university of medical sciences
Yazd reaserch and clinical center for infertilityshahid sadoughi university of medical sciences
مرکز تحقیقاتی و درمانی ناباروری
دانشگاه علوم پزشکی شهید صدوقی
مرکز تحقیقاتی و درمانی ناباروریدانشگاه علوم پزشکی شهید صدوقی
Person responsible for general 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: Maryam Eftekhar
Full name of responsible person - Persian: مریم افتخار
Position - English: assisted proffesor
Position - Persian: استادیار
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: 00
Fax: +98 38247087
Email: eftekhar@ssu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Maryam Eftekhar
Full name of responsible person - Persian: مریم افتخار
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: med_doctor
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 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: +98 913 156 3078
Fax:
Email: eftekhar@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: Maryam Eftekhar Full name of responsible person - Persian: مریم افتخار Position - English: assisted proffesorAssociate professor Position - Persian: استادیاردانشیار Latest degree: med_doctor 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 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: 00+98 913 156 3078 Fax: +98 38247087 Email: eftekhar@ssu.ac.ir 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: Maryam Eftekhar
Full name of responsible person - Persian: مریم افتخار
Position - English: assisted proffesor
Position - Persian: استادیار
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: +98 913 156 3087
Fax:
Email: eftekhar@ssu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Maryam Eftekhar
Full name of responsible person - Persian: مریم افتخار
Position - English: assisted proffesor
Position - Persian: استادیار
Latest degree: med_doctor
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 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: +98 913 156 3087
Fax:
Email: eftekhar@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: Maryam Eftekhar Full name of responsible person - Persian: مریم افتخار Position - English: assisted proffesor Position - Persian: استادیار Latest degree: med_doctor 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 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: +98 913 156 3087 Fax: Email: eftekhar@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: مركز تحقيقاتي درماني ناباروري يزد
Full name of responsible person - English: Maryam Farid Mojtahedi
Full name of responsible person - Persian: مریم فرید مجتهدی
Position - English: Infertility fellowship
Position - Persian: فلوشیپ
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: +98 912 123 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: مركز تحقيقاتي درماني ناباروري يزد
Full name of responsible person - English: Maryam Farid Mojtahedi
Full name of responsible person - Persian: مریم فرید مجتهدی
Position - English: Infertility fellowship
Position - Persian: فلوشیپ
Latest degree: med_doctor
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 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: +98 912 123 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: مركز تحقيقاتي درماني ناباروري يزد Full name of responsible person - English: Maryam Farid Mojtahedi Full name of responsible person - Persian: مریم فرید مجتهدی Position - English: Infertility fellowship Position - Persian: فلوشیپ Latest degree: med_doctor 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 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: +98 912 123 0934 Fax: Email: m_fmojtahedi@ssu.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
A journal in which the results are published
A journal in which the results are published
empty
ژورنال چاپ کننده نتایج
ژورنال چاپ کننده نتایج
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
Yazd Reproductive Sciences Institute
empty
مرکز تحقیقات ناباروری یزد
مرکز تحقیقات ناباروری یزد
empty
Submission of an official application
Submission of an official application
empty
درخواست رسمی
درخواست رسمی
Trial results
No
Yes
1
empty
2021-03-08, 1399/12/18
2021-03-08 05:06:08
empty
2017-07-01, 1396/04/10
2017-07-01 00:00:00
Participants Demographics characteristics of study participants
Group I (hCG +GnRHa) (n=99)
Group II (hCG)(n=93)
p-value
BMI
24.13 ± 2.87
24.07 ±2.98
0.88*
Age
30.06 ± 5.30
30.49 ± 4.79
0.54 *
Duration of infertility (yr)
6.34 ± 3.85
6.23 ± 4.09
0.70 *
Day-3 FSH level (IU/L)
6.59 ± 2.76
6.14 ± 2.59
0.23 *
Infertility type (%)
Primary
71.3
78.4
0.49**
Secondary
28.7
21.6
Participants Demographics characteristics of study participants
Group I (hCG +GnRHa) (n=99)
Group II (hCG)(n=93)
p-value
BMI
24.13 ± 2.87
24.07 ±2.98
0.88*
Age
30.06 ± 5.30
30.49 ± 4.79
0.54 *
Duration of infertility (yr)
6.34 ± 3.85
6.23 ± 4.09
0.70 *
Day-3 FSH level (IU/L)
6.59 ± 2.76
6.14 ± 2.59
0.23 *
Infertility type (%)
Primary
71.3
78.4
0.49**
Secondary
28.7
21.6
Comparison of clinical outcomes between two study groups
Group I (hCG +GnRHa) (n=99)
Group II (hCG) (n=93)
p-value*
Implantation rate
11
10
0.50
Chemical pregnancy rate
(30/99) 30.3
(24/93) 25.8
0.51
Clinical pregnancy rate
(26/99) 26.3
(21/93) 22.6
0.30
Ongoing pregnancy rate
(24/99) 24.2
(20/93) 22.9
0.77
Abortion rate
(2/25) 8
(4/24) 16.7
0.35
Comparison of clinical outcomes between two study groups
Group I (hCG +GnRHa) (n=99)
Group II (hCG) (n=93)
p-value*
Implantation rate
11
10
0.50
Chemical pregnancy rate
(30/99) 30.3
(24/93) 25.8
0.51
Clinical pregnancy rate
(26/99) 26.3
(21/93) 22.6
0.30
Ongoing pregnancy rate
(24/99) 24.2
(20/93) 22.9
0.77
Abortion rate
(2/25) 8
(4/24) 16.7
0.35
empty
Abstract
Background:
Gonadotropin-releasing hormone agonists (GnRH-a) was increasingly used for triggering oocyte maturationfor the prevention of ovarian hyperstimulation syndrome. Studies suggest that GnRH-a might be used as a better trigger agent since it causes both Luteinizing hormone and follicle stimulating hormone release from a physiologic natural cycle.
Objective:
The aim of this study was to evaluate the effect of dual-triggering in assisted reproductive technology outcomes.
Materials and Methods:
192 normal responder women aged ≤42 years and 18< Body Mass Index <30 kg/m2 enrolled in this single-blind randomized controlled trial. All participants received antagonist protocol. For final triggering, women randomly were divided into two groups. Group, I was triggered by 6500 IU human chorionic gonadotropin (hCG) alone, and group II by 6500 IU hCG plus 0.2 mg of triptorelin. The implantation, chemical, clinical and ongoing pregnancy, and abortion rates were measured.
Results:
The mean of retrieved oocytes and obtained embryos were statistically higher in the dual-trigger group (group I), but the implantation and pregnancy rates were similar in two groups.
Conclusion:
The results of our study did not confirm the favorable effect of dual-triggered oocyte maturation with a GnRH-a and a standard dosage of hCG as an effective strategy to optimize pregnancy outcome for normal responders in GnRH-antagonist cycles. We think that this new concept requires more studies before becoming a universal controlled ovarian hyperstimulation protocol in in vitro fertilization practice.
Abstract Background: Gonadotropin-releasing hormone agonists (GnRH-a) was increasingly used for triggering oocyte maturationfor the prevention of ovarian hyperstimulation syndrome. Studies suggest that GnRH-a might be used as a better trigger agent since it causes both Luteinizing hormone and follicle stimulating hormone release from a physiologic natural cycle. Objective: The aim of this study was to evaluate the effect of dual-triggering in assisted reproductive technology outcomes. Materials and Methods: 192 normal responder women aged ≤42 years and 18< Body Mass Index <30 kg/m2 enrolled in this single-blind randomized controlled trial. All participants received antagonist protocol. For final triggering, women randomly were divided into two groups. Group, I was triggered by 6500 IU human chorionic gonadotropin (hCG) alone, and group II by 6500 IU hCG plus 0.2 mg of triptorelin. The implantation, chemical, clinical and ongoing pregnancy, and abortion rates were measured. Results: The mean of retrieved oocytes and obtained embryos were statistically higher in the dual-trigger group (group I), but the implantation and pregnancy rates were similar in two groups. Conclusion: The results of our study did not confirm the favorable effect of dual-triggered oocyte maturation with a GnRH-a and a standard dosage of hCG as an effective strategy to optimize pregnancy outcome for normal responders in GnRH-antagonist cycles. We think that this new concept requires more studies before becoming a universal controlled ovarian hyperstimulation protocol in in vitro fertilization practice.
Protocol summary
Study aim
evaluation of dual triggering for final oocyte maturation with a single dose of GnRH-a and a standard dose of hCG in GnRH-antagonist IVF/ Intracytoplasmic sperm injection (ICSI) cycles in normal responders.
Design
The study was a phase 2 trial. Randomization was performed based on a table of computer random numbers.
Settings and conduct
The study was conducted at Yazd Infertility Research Center.The study was one-sided blind .
Participants/Inclusion and exclusion criteria
The inclusion criteria were 18< Body mass index <30 kg/m2, and age ≤42 yr with the history of infertility for at least 1 yr that were candidate for ART protocol. Our exclusion criteria were the presence of endocrine disorders such as diabetes mellitus, hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, Cushing syndrome, polycystic ovary syndrome, congenital uterine anomaliesdisorders, repeated implantation failure, day-3 FSH concentration ≥10 IU/L or serum anti-Mullerian hormone ≤1.0 ng/mL, and azoospermia.
Intervention groups
patients began ovarian stimulation with a flexible starting dosage of recombinant FSH ranging from 150 to 225 IU on the second day of the menstrual cycle for 5 consecutive days. Once the leading follicle had reached a size of 13 mm, co-treatment with the GnRH antagonist 0.25 mg/day, was initiated. When at least two leading follicles had reached 17 mm in diameter, final oocyte maturation was triggered by either 6500 I.U. hCG alone, or by 6500 IU hCG plus 0.2 mg of triptorelin (Decapeptyl; Ferring GmbH).Oocyte retrievals were performed under transvaginal ultrasound guidance 34 to 36 hours after triggering.
Main outcome variables
The primary outcome measure was clinical pregnancy rate and the secondary outcome measures were implantation rate,chemical pregnancy , ongoing pregnancy ,OHSS rate and abortion rate.
General information
Reason for update
Updating the trial according to the last changes in methods and adding results
Acronym
IRCT registration information
IRCT registration number:IRCT2015031221420N2
Registration date:2015-06-25, 1394/04/04
Registration timing:retrospective
Last update:2021-03-08, 1399/12/18
Update count:2
Registration date
2015-06-25, 1394/04/04
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
Yazd reserch and clinical center for infertility
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
2014-03-21, 1393/01/01
Actual recruitment end date
2015-02-01, 1393/11/12
Trial completion date
2015-03-02, 1393/12/11
Scientific title
A comparison of Dual triggering by administration of Gonadotropin releasing hormon agonist plus human chorionic gonadotropin versus HCG in normal responders at assisted reproductive programs outcome
Public title
Dual triggering in improving assisted reproductive programs outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
normal responder women by tubal or male infertility factor, 18< Body mass index <30 kg/m2, and age ≤42 yr with the history of infertility for at least 1 yr that were candidate for ART protocol
Exclusion criteria:
the presence of endocrine disorders such as diabetes mellitus, hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, Cushing syndrome, polycystic ovary syndrome, congenital uterine anomaliesdisorders, repeated implantation failure, day-3 FSH concentration ≥10 IU/L or serum anti-Mullerian hormone ≤1.0 ng/mL, and azoospermia
Age
To 42 years old
Gender
Female
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
192
Actual sample size reached:
192
Randomization (investigator's opinion)
Randomized
Randomization description
randomization was done by table of random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were named as groups 1 and 2. And the statistical analyzer did not know the type of treatment protocol used in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd Research and Clinical Center for infertility
Street address
Bouali Avenue, Safayeh
City
yazd
Province
Yazd
Postal code
891687391
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
315
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 rate
Timepoint
28 days after transfer
Method of measurement
vaginal sonography
Secondary outcomes
1
Description
chemical pregnancy rate
Timepoint
14 days after transfer
Method of measurement
BhCG test
Intervention groups
1
Description
control group receive 6500 I.U hCG IM for triggering final oocyte maturation .
Category
Treatment - Drugs
2
Description
Intervention group receive 6500 I.U. IM hCG+triptorelin0.2mg/sc for triggering.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali Avenue, Safayeh
Full name of responsible person
Abbas Aflatoonian
Street address
Bouali Avenue, Safayeh
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 3824 7085
Fax
Email
aflatoonian @ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahid sadoughi university of medical sciences
Full name of responsible person
masood mirzaee
Street address
bahonar Avenue,
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3732
Email
masood_mirzaei@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahid sadoughi university of medical sciences
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 University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate professor
Latest degree
Medical doctor
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
eftekhar@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
assisted proffesor
Latest degree
Medical doctor
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
eftekhar@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
Maryam Farid Mojtahedi
Position
Infertility fellowship
Latest degree
Medical doctor
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
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
A journal in which the results are published
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
What processes are involved for a request to access data/document
Submission of an official application
Comments
Trial results
Please tick if results have been published
Yes
Summary result posting date
2021-03-08, 1399/12/18
Table of baseline comparison
Participants Demographics characteristics of study participants
Group I (hCG +GnRHa) (n=99)
Group II (hCG)(n=93)
p-value
BMI
24.13 ± 2.87
24.07 ±2.98
0.88*
Age
30.06 ± 5.30
30.49 ± 4.79
0.54 *
Duration of infertility (yr)
6.34 ± 3.85
6.23 ± 4.09
0.70 *
Day-3 FSH level (IU/L)
6.59 ± 2.76
6.14 ± 2.59
0.23 *
Infertility type (%)
Primary
71.3
78.4
0.49**
Secondary
28.7
21.6
Participant flow diagram
Table of variable outcomes' results
Comparison of clinical outcomes between two study groups
Group I (hCG +GnRHa) (n=99)
Group II (hCG) (n=93)
p-value*
Implantation rate
11
10
0.50
Chemical pregnancy rate
(30/99) 30.3
(24/93) 25.8
0.51
Clinical pregnancy rate
(26/99) 26.3
(21/93) 22.6
0.30
Ongoing pregnancy rate
(24/99) 24.2
(20/93) 22.9
0.77
Abortion rate
(2/25) 8
(4/24) 16.7
0.35
Table of adverse events
First publication date
2017-07-01, 1396/04/10
Abstract of published paper
Abstract
Background:
Gonadotropin-releasing hormone agonists (GnRH-a) was increasingly used for triggering oocyte maturationfor the prevention of ovarian hyperstimulation syndrome. Studies suggest that GnRH-a might be used as a better trigger agent since it causes both Luteinizing hormone and follicle stimulating hormone release from a physiologic natural cycle.
Objective:
The aim of this study was to evaluate the effect of dual-triggering in assisted reproductive technology outcomes.
Materials and Methods:
192 normal responder women aged ≤42 years and 18< Body Mass Index <30 kg/m2 enrolled in this single-blind randomized controlled trial. All participants received antagonist protocol. For final triggering, women randomly were divided into two groups. Group, I was triggered by 6500 IU human chorionic gonadotropin (hCG) alone, and group II by 6500 IU hCG plus 0.2 mg of triptorelin. The implantation, chemical, clinical and ongoing pregnancy, and abortion rates were measured.
Results:
The mean of retrieved oocytes and obtained embryos were statistically higher in the dual-trigger group (group I), but the implantation and pregnancy rates were similar in two groups.
Conclusion:
The results of our study did not confirm the favorable effect of dual-triggered oocyte maturation with a GnRH-a and a standard dosage of hCG as an effective strategy to optimize pregnancy outcome for normal responders in GnRH-antagonist cycles. We think that this new concept requires more studies before becoming a universal controlled ovarian hyperstimulation protocol in in vitro fertilization practice.