Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle.
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Protocol summary
The current study is a clinical and prospective study. Patients are randomly assigned to two endometrial preparation groups. Basic ultrasound is performed for 100 patients on day 2 of the cycle and they are planned to be placed in each of the endometrial preparation protocols.
The current study is clinical and prospective. Patients are randomly assigned to two endometrial preparation groups. Basic ultrasound is performed for 128 patients on day 2 of the cycle and they are planned to be placed in each of the endometrial preparation protocols.
The current study is a clinical and prospective study. Patients are randomly assigned to two endometrial preparation groups. Basic ultrasound is performed for 100128 patients on day 2 of the cycle and they are planned to be placed in each of the endometrial preparation protocols.
مطالعه حاضر از نوع کارازمایی بالینی و آینده نگر می باشد. بیماران به روش تصادفی موازی وارد دو گروه آماده سازی آندومترمی شوند. برای 100بیمار در روز 2 سیکل، سونوگرافی پایه انجام می شود و برای قرارگیری در هریک از پروتکل آماده سازی اندومتر برنامه ریزی می گردد.
مطالعه حاضر از نوع کارازمایی بالینی و آینده نگر می باشد. بیماران به روش تصادفی موازی وارد دو گروه آماده سازی آندومترمی شوند. برای 128بیمار در روز 2 سیکل، سونوگرافی پایه انجام می شود و برای قرارگیری در هریک از پروتکل آماده سازی اندومتر برنامه ریزی می گردد.
مطالعه حاضر از نوع کارازمایی بالینی و آینده نگر می باشد. بیماران به روش تصادفی موازی وارد دو گروه آماده سازی آندومترمی شوند. برای 100بیمار128بیمار در روز 2 سیکل، سونوگرافی پایه انجام می شود و برای قرارگیری در هریک از پروتکل آماده سازی اندومتر برنامه ریزی می گردد.
Inclusion criteria :
Age 20-40 years with monthly menstrual cycles; Normal BMI (18-30 kg/m2)
; At the time of embryo transfer, at least one or two high quality embryos;
Patients with first or second transfusion
Exit criteria:
A history of frequent miscarriages;
Observation of uterine and ovarian abnormalities
Inclusion criteria :
Age 20-40 years with monthly menstrual cycles; Normal BMI (18-30 kg/m2)
; At the time of embryo transfer, at least one or two good-quality embryos;
Patients with first or second transfusion
Exit criteria:
Women with uterine anatomic abnormalities, hydrosalpinx, endometriosis.
ovulation disorders.
needed preimplantation genetic testing.
recurrent miscarriages and recurrent implantation failure.
medical conditions who were interdicted ART/pregnancy
Inclusion criteria : Age 20-40 years with monthly menstrual cycles; Normal BMI (18-30 kg/m2) ; At the time of embryo transfer, at least one or two high good-quality embryos; Patients with first or second transfusion Exit criteria: A history of frequent miscarriages; Observation ofWomen with uterine anatomic abnormalities, hydrosalpinx, endometriosis. ovulation disorders. needed preimplantation genetic testing. recurrent miscarriages and ovarian abnormalitiesrecurrent implantation failure. medical conditions who were interdicted ART/pregnancy
معیارهای ورود :
سن20- 40 سال با سیکل های قاعدگی ماهانه; BMI نرمال(18 - 30 kg/m2);
در زمان انتقال جنین حداقل یک یا دو جنین با کیفیت بالا; بیماران با انتقال اول یا دوم
معیارهای خروج :
سابقه سقط مکرر; مشاهده ناهنجاریهای رحمی و تخمدانی
معیارهای ورود :
سن20- 40 سال با سیکل های قاعدگی ماهانه; BMI نرمال(18 - 30 kg/m2);
در زمان انتقال جنین حداقل یک یا دو جنین با کیفیت خوب; بیماران با انتقال اول یا دوم
معیارهای خروج :
زنانی که با ناهنجاری های آناتومیک رحم، مادرزادی یا اکتسابی، هیدروسالپینکس و اندومتریوز تشخیص داده شدند.
بیماران مبتلا به اختلالات تخمک گذاری
زنانی که نیاز به آزمایش ژنتیکی قبل از لانه گزینی داشتند.
زنانی که از سقط های مکرر و شکست مکرر لانه گزینی رنج می بردند.
زنان با شرایط پزشکی که ممنوعیت ART/بارداری داشتند
معیارهای ورود : سن20- 40 سال با سیکل های قاعدگی ماهانه; BMI نرمال(18 - 30 kg/m2); در زمان انتقال جنین حداقل یک یا دو جنین با کیفیت بالاخوب; بیماران با انتقال اول یا دوم معیارهای خروج : سابقهزنانی که با ناهنجاری های آناتومیک رحم، مادرزادی یا اکتسابی، هیدروسالپینکس و اندومتریوز تشخیص داده شدند. بیماران مبتلا به اختلالات تخمک گذاری زنانی که نیاز به آزمایش ژنتیکی قبل از لانه گزینی داشتند. زنانی که از سقط های مکرر; مشاهده ناهنجاریهای رحمی و تخمدانیشکست مکرر لانه گزینی رنج می بردند. زنان با شرایط پزشکی که ممنوعیت ART/بارداری داشتند
General information
Not blinded
Single blinded
notblsingl
1
1
1
1
No
Yes
1
empty
50
50
empty
128
128
No
Yes
1
empty
64
64
2024-08-31, 1403/06/10
2024-07-22, 1403/05/01
2024-0807-3122 00:00:00
empty
2024-04-29, 1403/02/10
2024-04-29 00:00:00
empty
2024-08-07, 1403/05/17
2024-08-07 00:00:00
empty
2024-10-21, 1403/07/30
2024-10-21 00:00:00
empty
The study's sampling and completion were completed later than the announced time, and the realized volume was greater than the determined sample size. In addition, more outcomes were examined.
The study's sampling and completion were completed later than the announced time, and the realized volume was greater than the determined sample size. In addition, more outcomes were examined.
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نمونه گیری و پایان تحقیق دیر تر از زمان اعلامی، پایان یافته است و حجم تحقق یافته بیشتر از حجم نمونه تعیین شده می باشد. ضمنا out come های بیشتری بررسی شده است.
نمونه گیری و پایان تحقیق دیر تر از زمان اعلامی، پایان یافته است و حجم تحقق یافته بیشتر از حجم نمونه تعیین شده می باشد. ضمنا out come های بیشتری بررسی شده است.
Age 20-40 years with monthly menstrual cycles of 21 to 35 days
Normal BMI (18-30 kg/m2)
At the time of embryo transfer, there should be at least one or two embryos with A-B quality
Patients with first or second transfer
Age 20-40 years with monthly menstrual cycles of 21 to 35 days
Normal BMI (18-30 kg/m2)
At the time of embryo transfer, there should be at least one or two embryos with good-quality
Patients with first or second transfer
Age 20-40 years with monthly menstrual cycles of 21 to 35 days Normal BMI (18-30 kg/m2) At the time of embryo transfer, there should be at least one or two embryos with Agood-B quality Patients with first or second transfer
سن20- 40 سال با سیکل های قاعدگی ماهانه 21 تا 35 روز
BMI نرمال (18- 30 kg/m2)
در زمان انتقال جنین حداقل یک یا دو جنین با کیفیت A-B وجود داشته باشد
بیماران با انتقال اول یا دوم
سن20- 40 سال با سیکل های قاعدگی ماهانه 21 تا 35 روز
BMI نرمال (18- 30 kg/m2)
در زمان انتقال جنین حداقل یک یا دو جنین با کیفیت خوب وجود داشته باشد
بیماران با انتقال اول یا دوم
سن20- 40 سال با سیکل های قاعدگی ماهانه 21 تا 35 روز BMI نرمال (18- 30 kg/m2) در زمان انتقال جنین حداقل یک یا دو جنین با کیفیت A-Bخوب وجود داشته باشد بیماران با انتقال اول یا دوم
Women who were diagnosed with uterine anatomic abnormalities, either inborn or acquired, hydrosalpinx, and endometriosis.
The patients with ovulation disorders.
Women who needed preimplantation genetic testing.
Women who suffered from recurrent miscarriages and recurrent implantation failure.
Women with medical conditions who were interdicted ART/pregnancy.
Women who were diagnosed with uterine anatomic abnormalities, either inborn or acquired, hydrosalpinx, and endometriosis. The patients with ovulation disorders. Women who needed preimplantation genetic testing. Women who suffered from recurrent miscarriages and recurrent implantation failure. Women with medical conditions who were interdicted ART/pregnancy.
زنانی که با ناهنجاری های آناتومیک رحم، مادرزادی یا اکتسابی، هیدروسالپینکس و اندومتریوز تشخیص داده شدند.
بیماران مبتلا به اختلالات تخمک گذاری
زنانی که نیاز به آزمایش ژنتیکی قبل از لانه گزینی داشتند.
زنانی که از سقط های مکرر و شکست مکرر لانه گزینی رنج می بردند.
زنان با شرایط پزشکی که ممنوعیت ART/بارداری داشتند.
زنانی که با ناهنجاری های آناتومیک رحم، مادرزادی یا اکتسابی، هیدروسالپینکس و اندومتریوز تشخیص داده شدند. بیماران مبتلا به اختلالات تخمک گذاری زنانی که نیاز به آزمایش ژنتیکی قبل از لانه گزینی داشتند. زنانی که از سقط های مکرر و شکست مکرر لانه گزینی رنج می بردند. زنان با شرایط پزشکی که ممنوعیت ART/بارداری داشتند.
The present study is a single-blind RCT in which the embryologist and data assessor were blind to treatment groups. Therefore, patients were not blinded to comply with ethical issues and gave the patient the right to choose. Moreover, double blinding was not possible due to the intervention method. The doctor and the patient were aware of the intervention procedure.
The present study is a single-blind RCT in which the embryologist and data assessor were blind to treatment groups. Therefore, patients were not blinded to comply with ethical issues and gave the patient the right to choose. Moreover, double blinding was not possible due to the intervention method. The doctor and the patient were aware of the intervention procedure.
مطالعه حاضر یک RCT یک سوکور است که در آن جنین شناس و ارزیاب داده ها نسبت به گروه های درمانی Blind بودند. بنابراین بیماران برای رعایت مسائل اخلاقی کور نبودند و به بیمار حق انتخاب می دادند. همچنین با توجه به روش مداخله امکان دو سو کوری وجود نداشت.
پزشک و بیمار ازروند مداخله آگاه بودند
مطالعه حاضر یک RCT یک سوکور است که در آن جنین شناس و ارزیاب داده ها نسبت به گروه های درمانی Blind بودند. بنابراین بیماران برای رعایت مسائل اخلاقی کور نبودند و به بیمار حق انتخاب می دادند. همچنین با توجه به روش مداخله امکان دو سو کوری وجود نداشت. پزشک و بیمار ازروند مداخله آگاه بودند
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50 people per group
50 people per group
empty
50 نفر در هر گروه
50 نفر در هر گروه
empty
64 people per group
64 people per group
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64 نفر در هر گروه
64 نفر در هر گروه
Primary outcomes
#1
5 weeks after embryo transfer
5 weeks after embryo transfer or 8th week of pregnancy
5 weeks after embryo transfer or 8th week of pregnancy
5 هفته بعد ازانتقال جنین
5 هفته بعد ازانتقال جنین یا هفته هشتم بارداری
5 هفته بعد ازانتقال جنین یا هفته هشتم بارداری
Secondary outcomes
#1
2 to 3 weeks after embryo transfer
the 8th week of pregnancy
2 to 3 weeks after embryo transferthe 8th week of pregnancy
2 تا 3 هفته بعد از انتقال جنین
هشتمین هفته حاملگی
2 تا 3هشتمین هفته بعد از انتقال جنینحاملگی
#2
Miscarriage rate of lack of fetal development after observing gestational sac in ultrasound
Miscarriage rate (loss of clinical pregnancy before the 12th gestational week)
Miscarriage rate of lack(loss of fetal development after observingclinical pregnancy before the 12th gestational sac in ultrasoundweek)
میزان سقط عدم رشد جنین پس از مشاهده ساک حاملگی در سونوگرافی
میزان سقط جنین (از دست دادن بارداری بالینی قبل از هفته دوازدهم بارداری)
میزان سقط عدم رشد جنین پس(از دست دادن بارداری بالینی قبل از مشاهده ساک حاملگی در سونوگرافیهفته دوازدهم بارداری)
5 to 6 weeks after embryo transfer
before the 12th gestational week
5 to 6 weeks after embryo transferbefore the 12th gestational week
5 تا 6 هفته بعد از انتقال جنین
قبل ازهفته دوازدهم بارداری
5 تا 6 هفته بعد از انتقال جنینقبل ازهفته دوازدهم بارداری
#3
Endometrial thickness on the day of embryo transfer
implantation rate (IR was defined as the number of gestational sacs determined by sonogram divided by the number of frozen embryos transferred )
Endometrial thickness onimplantation rate (IR was defined as the daynumber of embryo transfergestational sacs determined by sonogram divided by the number of frozen embryos transferred )
ضخامت آندومتر در روز انتقال جنین
نرخ لانه گزینی (IR به عنوان تعداد کیسه های حاملگی تعیین شده توسط سونوگرافی تقسیم بر تعداد جنین های منجمد منتقل شده تعریف شد)
ضخامت آندومتر در روز انتقالنرخ لانه گزینی (IR به عنوان تعداد کیسه های حاملگی تعیین شده توسط سونوگرافی تقسیم بر تعداد جنین های منجمد منتقل شده تعریف شد)
Embryo transfer day
6th gestational week
Embryo transfer day6th gestational week
روز انتقال جنین
ششمین هفته بارداری
روز انتقال جنینششمین هفته بارداری
Trans vaginal ultrasound
transvaginal ultrasound
Trans vaginaltransvaginal ultrasound
#4
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ectopic pregnancy rate (EPR) (refers to the presence of a gestational sac outside the uterine cavity)
ectopic pregnancy rate (EPR) (refers to the presence of a gestational sac outside the uterine cavity)
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میزان حاملگی خارج از رحم (EPR) (به وجود کیسه حاملگی در خارج از حفره رحم اشاره دارد)
میزان حاملگی خارج از رحم (EPR) (به وجود کیسه حاملگی در خارج از حفره رحم اشاره دارد)
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6 to 7th gestational week
6 to 7th gestational week
empty
شش تا هفتمین هفته بارداری
شش تا هفتمین هفته بارداری
empty
Laboratory test and transvaginal ultrasound
Laboratory test and transvaginal ultrasound
empty
تست آزمایشگاهی و سونوگرافی ترانس واژینال
تست آزمایشگاهی و سونوگرافی ترانس واژینال
#5
empty
twin pregnancy rate (TPR)
twin pregnancy rate (TPR)
empty
میزان بارداری دوقلو
میزان بارداری دوقلو
empty
the 8th week of pregnancy
the 8th week of pregnancy
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هشتمین هفته حاملگی
هشتمین هفته حاملگی
empty
transvaginal ultrasound
transvaginal ultrasound
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سونوگرافی ترانس واژینال
سونوگرافی ترانس واژینال
#6
empty
ongoing pregnancy (Ongoing pregnancy was defined as a continuation of pregnancy after the 12th week of gestation).
ongoing pregnancy (Ongoing pregnancy was defined as a continuation of pregnancy after the 12th week of gestation).
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حاملگی در حال انجام (بارداری در حال انجام به عنوان ادامه بارداری پس از هفته دوازدهم بارداری تعریف شد).
حاملگی در حال انجام (بارداری در حال انجام به عنوان ادامه بارداری پس از هفته دوازدهم بارداری تعریف شد).
empty
after the 12th week of gestation
after the 12th week of gestation
empty
بعد از هفته دوازدهم بارداری
بعد از هفته دوازدهم بارداری
empty
Abdominal ultrasound
Abdominal ultrasound
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سونوگرافی شکمی
سونوگرافی شکمی
#7
empty
rates of positive hCG,( positive hCG was defined as B-hCG > 10 IU/l measured 14 days after transfer)
rates of positive hCG,( positive hCG was defined as B-hCG > 10 IU/l measured 14 days after transfer)
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نرخ hCG مثبت، (hCG مثبت به عنوان B-hCG> 10 IU/l که 14 روز پس از انتقال اندازه گیری شد، تعریف شد)
نرخ hCG مثبت، (hCG مثبت به عنوان B-hCG> 10 IU/l که 14 روز پس از انتقال اندازه گیری شد، تعریف شد)
empty
14 days after embryo transfer
14 days after embryo transfer
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14 روز پس از انتقال جنین
14 روز پس از انتقال جنین
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Laboratory test
Laboratory test
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تست آزمایشگاهی
تست آزمایشگاهی
Intervention groups
#1
Intervention group: Patients in the modified normal cycle (mNC-FET) group underwent transvaginal ultrasound on day 10 to 12 of the menstrual cycle to determine the size of the dominant follicle and thus the ovulation induction time. If the ovulation induction time is not determined on the 12th day, the transvaginal ultrasound is repeated 2 days later. And when a follicle equal to or greater than 18 mm is seen, ovulation is induced by injecting 0.25 micrograms of r-hCG (6500 IU Ovitrelle). Embryo transfer will be done 5-6 days after ovulation induction, and they will receive 800 mg of micronized progesterone daily for four to five days until the time of embryo transfer, and based on the condition of the frozen embryo, 24-48 hours before the time set for Transfer will melt.
Intervention group: Patients in the modified normal cycle (mNC-FET) group underwent transvaginal ultrasound on day 10 to 12 of the menstrual cycle to determine the size of the dominant follicle and thus the ovulation induction time. If the ovulation induction time is not determined on the 12th day, the transvaginal ultrasound is repeated 2 days later. And when a follicle equal to or greater than 18 mm is seen, ovulation is induced by injecting 250 micrograms of r-hCG (6500 IU Ovitrelle). Embryo transfer will be done 5-6 days after ovulation induction, and they will receive 800 mg of micronized progesterone daily for four to five days until the time of embryo transfer, and based on the condition of the frozen embryo, 24-48 hours before the time set for Transfer will melt.
Intervention group: Patients in the modified normal cycle (mNC-FET) group underwent transvaginal ultrasound on day 10 to 12 of the menstrual cycle to determine the size of the dominant follicle and thus the ovulation induction time. If the ovulation induction time is not determined on the 12th day, the transvaginal ultrasound is repeated 2 days later. And when a follicle equal to or greater than 18 mm is seen, ovulation is induced by injecting 0.25250 micrograms of r-hCG (6500 IU Ovitrelle). Embryo transfer will be done 5-6 days after ovulation induction, and they will receive 800 mg of micronized progesterone daily for four to five days until the time of embryo transfer, and based on the condition of the frozen embryo, 24-48 hours before the time set for Transfer will melt.
گروه مداخله: بیماران در گروه سیکل طبیعی اصلاح شده (mNC-FET) در روز10 تا 12 سیکل قاعدگی برای تعیین اندازه فولیکول غالب و در نتیجه زمان القای تخمک گذاری سونوگرافی ترانس واژینال می شوند. اگر زمان القائ تخمک گذاری در روز 12 تعیین نشد، سونوگرافی ترانس واژینال 2 روز بعد تکرار می شود.و زمانیکه یک فولیکول مساوی ویا بیشتر از 18میلی متررویت شود،تخمک گذاری با تزریق0 25 میکروگرمr-hCG (6500 IU Ovitrelle ) القاء میشود. انتقال جنین 5-6 روز بعد از القای تخمک گذاری انجام خواهد شد و روزانه 800 میلی‌گرم پروژسترون میکرونیزه به مدت چهار- پنج روز تا زمان انتقال جنین دریافت خواهندکرد و بر اساس وضعیت جنین فریز شده، 24 تا 48 ساعت قبل از زمان تعیین شده برای انتقال، ذوب خواهد شد.
گروه مداخله: بیماران در گروه سیکل طبیعی اصلاح شده (mNC-FET) در روز10 تا 12 سیکل قاعدگی برای تعیین اندازه فولیکول غالب و در نتیجه زمان القای تخمک گذاری سونوگرافی ترانس واژینال می شوند. اگر زمان القائ تخمک گذاری در روز 12 تعیین نشد، سونوگرافی ترانس واژینال 2 روز بعد تکرار می شود.و زمانیکه یک فولیکول مساوی ویا بیشتر از 18میلی متررویت شود،تخمک گذاری با تزریق250 میکروگرمr-hCG (6500 IU Ovitrelle ) القاء میشود. انتقال جنین 5-6 روز بعد از القای تخمک گذاری انجام خواهد شد و روزانه 800 میلی‌گرم پروژسترون میکرونیزه به مدت چهار- پنج روز تا زمان انتقال جنین دریافت خواهندکرد و بر اساس وضعیت جنین فریز شده، 24 تا 48 ساعت قبل از زمان تعیین شده برای انتقال، ذوب خواهد شد.
گروه مداخله: بیماران در گروه سیکل طبیعی اصلاح شده (mNC-FET) در روز10 تا 12 سیکل قاعدگی برای تعیین اندازه فولیکول غالب و در نتیجه زمان القای تخمک گذاری سونوگرافی ترانس واژینال می شوند. اگر زمان القائ تخمک گذاری در روز 12 تعیین نشد، سونوگرافی ترانس واژینال 2 روز بعد تکرار می شود.و زمانیکه یک فولیکول مساوی ویا بیشتر از 18میلی متررویت شود،تخمک گذاری با تزریق0 25تزریق250 میکروگرمr-hCG (6500 IU Ovitrelle ) القاء میشود. انتقال جنین 5-6 روز بعد از القای تخمک گذاری انجام خواهد شد و روزانه 800 میلی‌گرم پروژسترون میکرونیزه به مدت چهار- پنج روز تا زمان انتقال جنین دریافت خواهندکرد و بر اساس وضعیت جنین فریز شده، 24 تا 48 ساعت قبل از زمان تعیین شده برای انتقال، ذوب خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: Imam Khomeini Hospital, Sari
Name of recruitment center - Persian: بیمارستان امام خمینی ساری
Full name of responsible person - English: Dr. Sepideh Peivandi
Full name of responsible person - Persian: دکتر سپیده پیوندی
Street address - English: Amir Mazandarani St
Street address - Persian: خیابان امیر مازندرانی
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4816633131
Phone: +98 11 3336 1700
Fax: +98 11 3336 3754
Email: emamsarih@gmail.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital, Sari
Name of recruitment center - Persian: بیمارستان امام خمینی ساری
Full name of responsible person - English: Dr. Sepideh Peivandi
Full name of responsible person - Persian: دکتر سپیده پیوندی
Street address - English: Amir Mazandarani Street
Street address - Persian: خیابان امیر مازندرانی
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4816633131
Phone: +98 11 3336 1700
Fax: +98 11 3336 3754
Email: emamsarih@gmail.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital, Sari Name of recruitment center - Persian: بیمارستان امام خمینی ساری Full name of responsible person - English: Dr. Sepideh Peivandi Full name of responsible person - Persian: دکتر سپیده پیوندی Street address - English: Amir Mazandarani StStreet Street address - Persian: خیابان امیر مازندرانی City - English: Sari City - Persian: ساری Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: 4816633131 Phone: +98 11 3336 1700 Fax: +98 11 3336 3754 Email: emamsarih@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Farhad Gholami
Full name of responsible person - Persian: دکتر فرهاد غلامی
Street address - English: Imam Khomeini Square, Joibar Street, the beginning of Valiasr Highway
Street address - Persian: میدان امام خمینی، سه راه جویبار، ابتدای بزرگراه ولیعصر
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4815733971
Phone: +98 11 3304 4000
Fax:
Email: ravabetomoomi@mazums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Farhad Gholami
Full name of responsible person - Persian: دکتر فرهاد غلامی
Street address - English: The beginning of Valiasr Highway, Joibar Three Roads, Imam Khomeini Square
Street address - Persian: میدان امام خمینی، سه راه جویبار، ابتدای بزرگراه ولیعصر
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4815733971
Phone: +98 11 3304 4000
Fax:
Email: ravabetomoomi@mazums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.Farhad Gholami Full name of responsible person - Persian: دکتر فرهاد غلامی Street address - English: Imam Khomeini Square, Joibar Street, theThe beginning of Valiasr Highway, Joibar Three Roads, Imam Khomeini Square Street address - Persian: میدان امام خمینی، سه راه جویبار، ابتدای بزرگراه ولیعصر City - English: Sari City - Persian: ساری Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: 4815733971 Phone: +98 11 3304 4000 Fax: Email: ravabetomoomi@mazums.ac.ir Web page address:
Protocol summary
Study aim
Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone administration method and natural modified method in frozen embryo transfer cycle.
Design
The current study is clinical and prospective. Patients are randomly assigned to two endometrial preparation groups. Basic ultrasound is performed for 128 patients on day 2 of the cycle and they are planned to be placed in each of the endometrial preparation protocols.
Settings and conduct
This study is conducted in Imam Khomeini Hospital in Sari
Patients in the modified normal cycle group undergo an ultrasound scan on day 10 to 12 of the menstrual cycle to determine the size of the dominant follicle. And when a follicle equal to or greater than 18 mm is seen, ovulation is induced by Ovitrelle injection, and progesterone begins three days later of Ovitrelle injection . will be For patients in the hormone administration cycle group treated with estradiol valerate, ultrasound is performed starting from the 2nd day of menstruation and approximately 10 days after the start of estradiol treatment, when the thickness of the endometrium reaches 8 mm, progesterone will start.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Age 20-40 years with monthly menstrual cycles; Normal BMI (18-30 kg/m2)
; At the time of embryo transfer, at least one or two good-quality embryos;
Patients with first or second transfusion
Exit criteria:
Women with uterine anatomic abnormalities, hydrosalpinx, endometriosis.
ovulation disorders.
needed preimplantation genetic testing.
recurrent miscarriages and recurrent implantation failure.
medical conditions who were interdicted ART/pregnancy
Intervention groups
Two groups of frozen embryo transfer with endometrium preparation protocol with hormone administration method and natural modified method
Main outcome variables
Clinical pregnancy
General information
Reason for update
The study's sampling and completion were completed later than the announced time, and the realized volume was greater than the determined sample size. In addition, more outcomes were examined.
Acronym
IRCT registration information
IRCT registration number:IRCT20240302061147N1
Registration date:2024-05-27, 1403/03/07
Registration timing:registered_while_recruiting
Last update:2025-01-06, 1403/10/17
Update count:3
Registration date
2024-05-27, 1403/03/07
Registrant information
Name
Farnaz Safarloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 508 3244
Email address
safarloo203@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
2024-04-29, 1403/02/10
Actual recruitment end date
2024-08-07, 1403/05/17
Trial completion date
2024-10-21, 1403/07/30
Scientific title
Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle.
Public title
Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-40 years with monthly menstrual cycles of 21 to 35 days
Normal BMI (18-30 kg/m2)
At the time of embryo transfer, there should be at least one or two embryos with good-quality
Patients with first or second transfer
Exclusion criteria:
Women who were diagnosed with uterine anatomic abnormalities, either inborn or acquired, hydrosalpinx, and endometriosis.
The patients with ovulation disorders.
Women who needed preimplantation genetic testing.
Women who suffered from recurrent miscarriages and recurrent implantation failure.
Women with medical conditions who were interdicted ART/pregnancy.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
50
50 people per group
Actual sample size reached:
128
More than 1 sample in each individual
Actual sample size in each individual:
64
64 people per group
Randomization (investigator's opinion)
Randomized
Randomization description
Infertile patients who refer to Imam Hospital in Sari city, after obtaining their consent, are randomly assigned in a one-to-one ratio and enter one of the two endometrial preparation groups. Blocking is done in each group based on age (less than 35 years old and 35 to 40 years old).
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is a single-blind RCT in which the embryologist and data assessor were blind to treatment groups. Therefore, patients were not blinded to comply with ethical issues and gave the patient the right to choose. Moreover, double blinding was not possible due to the intervention method. The doctor and the patient were aware of the intervention procedure.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Infertility Department,Imam Khomeini hospital, razi street, Sari city, Mazandaran province, Iran
City
sari
Province
Mazandaran
Postal code
4816633131
Approval date
2024-01-15, 1402/10/25
Ethics committee reference number
ir.mazums.imamhospital.rec.1402.125
Health conditions studied
1
Description of health condition studied
Frozen embryo transfer in modified natural cycle
ICD-10 code
N97.4
ICD-10 code description
Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle
Primary outcomes
1
Description
Clinical pregnancy so that the heartbeat of the fetus can be seen in ultrasound
Timepoint
5 weeks after embryo transfer or 8th week of pregnancy
Method of measurement
By transvaginal ultrasound
Secondary outcomes
1
Description
The rate of chemical pregnancy in which only the pregnancy test is positive
Timepoint
the 8th week of pregnancy
Method of measurement
Laboratory test and transvaginal ultrasound
2
Description
Miscarriage rate (loss of clinical pregnancy before the 12th gestational week)
Timepoint
before the 12th gestational week
Method of measurement
Trans vaginal ultrasound
3
Description
implantation rate (IR was defined as the number of gestational sacs determined by sonogram divided by the number of frozen embryos transferred )
Timepoint
6th gestational week
Method of measurement
transvaginal ultrasound
4
Description
ectopic pregnancy rate (EPR) (refers to the presence of a gestational sac outside the uterine cavity)
Timepoint
6 to 7th gestational week
Method of measurement
Laboratory test and transvaginal ultrasound
5
Description
twin pregnancy rate (TPR)
Timepoint
the 8th week of pregnancy
Method of measurement
transvaginal ultrasound
6
Description
ongoing pregnancy (Ongoing pregnancy was defined as a continuation of pregnancy after the 12th week of gestation).
Timepoint
after the 12th week of gestation
Method of measurement
Abdominal ultrasound
7
Description
rates of positive hCG,( positive hCG was defined as B-hCG > 10 IU/l measured 14 days after transfer)
Timepoint
14 days after embryo transfer
Method of measurement
Laboratory test
Intervention groups
1
Description
Intervention group: Patients in the modified normal cycle (mNC-FET) group underwent transvaginal ultrasound on day 10 to 12 of the menstrual cycle to determine the size of the dominant follicle and thus the ovulation induction time. If the ovulation induction time is not determined on the 12th day, the transvaginal ultrasound is repeated 2 days later. And when a follicle equal to or greater than 18 mm is seen, ovulation is induced by injecting 250 micrograms of r-hCG (6500 IU Ovitrelle). Embryo transfer will be done 5-6 days after ovulation induction, and they will receive 800 mg of micronized progesterone daily for four to five days until the time of embryo transfer, and based on the condition of the frozen embryo, 24-48 hours before the time set for Transfer will melt.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Dr. Sepideh Peivandi
Street address
Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
+98 11 3336 3754
Email
emamsarih@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Farhad Gholami
Street address
The beginning of Valiasr Highway, Joibar Three Roads, Imam Khomeini Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
ravabetomoomi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
10
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
Mazandaran University of Medical Sciences
Full name of responsible person
Farnaz Safarlou
Position
Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Center of Imam Khomeini Hospital, Razi Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
Safarloo203@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farnaz Safarlou
Position
Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Center of Imam Khomeini Hospital, Razi Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
Safarloo203@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farnaz Safarloo
Position
Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Center, Imam Khomeini Hospital, Razi Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
Safarloo203@gmail.com
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
The design protocol, demographic information of the patients, and statistical results will be published as an article after the end of the study
When the data will become available and for how long
After publication in one of the authoritative publications
To whom data/document is available
Academic centers and infertility researchers
Under which criteria data/document could be used
Research exploitation
From where data/document is obtainable
Email of researchers and Mazandaran University of Medical Sciences
What processes are involved for a request to access data/document