1. Home
  2. Approved trials
  3. » فارسی

Comparison of Fresh and Frozen Embryo Transfer in GnRH Agonist Triggered patients: A Multicenter Study

View the latest revision

History
# Registration date Revision Id
3 2021-03-03, 1399/12/13 176202
2 2016-10-03, 1395/07/12 20671
1
This trial has some update history items in old IRCT format. To see these history items click here.
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    The aim of the current study is evaluation of pregnancy rate in patients at risk for Ovarian Hyper Stimulation Syndrome (OHSS) who will be triggered with Gonadotropin-releasing hormone (GnRHa) in antagonist cycle. In this multi-center study, 280 women with high OHSS risk will be selected and divided randomly into two groups on the day of oocyte retrieval. There is no blindness in the study. The difference between groups is fresh embryo transfer in current cycle or embryo freezing and transfer of frozen –thawed embryos in the next cycle. At first, ovarian stimulation will be performed using antagonist protocol with administration of 150-200 IU gonadotropin. Patients who have14 to 25 follicles with the diameter more than 12 mm on the day of trigger and Body Mass Index (BMI) between 18-35 will be selected and triggered with GnRHa and will be divided to two groups randomly at the same day. In one group all embryos will be freezed and in another group two fresh embryos will be transferred. Chemical and clinical pregnancy rate will be compared between groups.
    empty
    هدف اصلی این مطالعه ارزیابی میزان حاملگی در بین بیماران با خطر سندرم تحریک بیش از حد تخمدان است که در سیکلهای آنتاگونیست با استفاده از آگونیستGonadotropin-releasing hormone (GnRh) تریگر شده اند. در این مطالعه چند مرکزی جمعیت مورد مطالعه 280بیمار زن هستند که در معرض سندرم تحریک بیش از حد تخمدان قرار دارند و در روز پونکسیون تخمک به صورت تصادفی به دو گروه تقسیم شده اند. در این مطالعه کورسازی وجود ندارد. اختلاف دو گروه در انتقال جنینهای تازه در همان سیکل و یا منجمد نمودن آنها و استفاده از جنین ذوب شده در سیکل بعد می باشد. ابتدا بیماران با ۱۵۰-۲۰۰ واحد گنادوتروپین و پروتوکل انتاگونیست تحریک می شوند سپس بیمارانی که در روز تریگرینگ ۱۴-۲۵ فولیکول ≤۱۲میلیمتر و شاخص توده بدنی بین 18 تا 35 دارند و سابقه سندرم تحریک بیش از حد تخمدان در آنها وجود ندارد، انتخاب شده با اگونیست GnRH تریگر شده ودر این روز به صورت تصادفی به دو گروه تقسیم می شوند. در یک گروه همه جنینها فریز می شوند و در گروه دیگر ۲ جنین به صورت تازه انتقال داده میشوند وسپس متغیرهایی مثل میزان حاملگی شیمیایی و کلینیکی در دو گروه مقایسه میشوند.
    empty
    empty
    Compare the reproductive outcomes of fresh vs frozen embryo transfer in high responder IVF patients triggered with GnRHa
    empty
    مقایسه پیامدهای حاملگی در سیکلهای با انتقال جنین تازه و جنین منجمد در بیماران با پاسخ زیاد به تحریک تخمدان که بوسیله GnRHa تریگر شده اند.
    empty
    Women at risk for OHSS who were stimulated with GnRH antagonist protocol and triggered with GnRHa for oocyte triggering were randomly divided into two groups of either fresh embryo transfer or frozen embryo transfer on the day of oocyte triggering. In this not-blinded, phase 2 clinical trial without control group, randomization was performed using random number table.
    empty
    بیماران در معرض سندرم تخمدان پلی کیستیک و تحریک شده با پروتکل GnRH آنتاگونیست و تریگر شده با پروتکل GnRH آگونیست در روز تریگر اووسیت به صورت تصادفی به دو گروه انتقال جنین تازه و یا انتقال جنین منجمد تقسیم شدند. در این کارازمایی بالینی بدون گروه کنترل با گروه های موازی، بدون کورسازی و فاز 2 تصادفی سازی با استفاده از جدول اعداد تصادفی صورت گرفت.
    empty
    In this multicenter, randomized clinical trial, infertile women at risk of OHSS were recruited at three fertility clinics in Iran; Yazd Research and Clinical Center for Infertility, Yazd Madar Hospital, Mashhad Novin Fertility and Infertility Center. Women were randomized into two groups. Pregnancy outcome were assessed in FET and fresh embryo transfer groups.
    empty
    در یک کارازمایی بالینی تصادفی سازی شده چند مرکزی، زنان در معرض خطر سندرم تحریک بیش از حد تخمدان در مرکز تحقیقاتی و درمانی ناباروری یزد، بیمارستان مادر یزد و مرکز ناباروری نوین مشهد وارد مطالعه شدند. پیامدهای بارداری در بیماران با انتقال جنین تازه و منجمد سنجیده شد.
    empty
    Patients with OHSS risk at the age between 20-40 yr and having a number of 14-25 follicles ≥12 mm on the day of trigger and a body mass index >18 and <35 kg/m2 without a previous history of OHSS development.
    empty
    بیمارانی در معرض سندرم تحریک بیش از حد تخمدان 20تا 40 ساله که در روز تریگرینگ ۱۴-۲۵ فولیکول ≤۱۲میلیمتر و شاخص توده بدنی بین 18 تا 35 دارند و سابقه سندرم تحریک بیش از حد تخمدان در آنها وجود ندارد.
    empty
    Group 1: Women were stimulated with GnRH antagonist protocol and triggered with GnRHa for oocyte triggering with fresh embryo transfer Group 2: Women were stimulated with GnRH antagonist protocol and triggered with GnRHa for oocyte triggering with frozen embryo transfer
    empty
    گروه اول: بیماران تحریک شده با پروتکل GnRH آنتاگونیست و تریگر شده با پروتکل GnRH آگونیست در روز تریگر اووسیت با انتقال جنین تازه گروه دوم: بیماران تحریک شده با پروتکل GnRH آنتاگونیست و تریگر شده با پروتکل GnRH آگونیست در روز تریگر اووسیت با انتقال جنین منجمد
    empty
    The primary outcome parameter was clinical pregnancy and the secondary outcome parameters were chemical pregnancy; live birth; OHSS development; and perinatal outcomes.
    empty
    پیامد اولیه حاملگی بالینی و پیامدهای ثانویه حاملگی شیمیایی; تولد زنده; سندرم تحریک بیش از حد تخمدان; و پیامدهای پریناتال

  • General information

    280
    1280
    empty
    280
    2017-01-01, 1395/10/12
    2015-12-30, 1394/10/09
    empty
    2014-01-01, 1392/10/11
    empty
    2015-12-30, 1394/10/09
    empty
    2017-01-30, 1395/11/11
    empty
    Updating the trial regarding actual sample size, actual recruitment start and end dates
    empty
    به روزرسانی کارآزمایی بالینی در مورد تعداد نمونه نهایی، تاریخ دقیق شروع و پایان بیمارگیری
    Age between 20-40
    Hyper responded patients
    Detection of 14-25 follicles ≥ 12 mm on day of trigger
    BMI >18 and <35 kg/m2
    سن بین 20-40 سال
    بیماران با پاسخ زیاد به تحریک تخمدان
    داشتن 14 تا 25 فولیکول بیشتر یا مساوی 12 میلی متر در روز تریگر
    شاخص توده بدنی بین 18 و 35
    Patients with <14 follicles and > 25 ≥ 12 mm on day of trigge
    Previous OHSS
    Endocrine disorders
    بیماران با بیش از 25 و کمتر از 14 فولیکول با قطر بیشتر یا مساوی 12 میلی متر در روز تریگر
    سابقه قبلی از سندرم تحریک بیش از حد تخمدان
    بیماری اندوکرین
    empty
    In this multicenter, randomized clinical trial, 280 infertile women at risk of OHSS were enrolled in the study. All patients were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual using a random number table.
    empty
    در این مطالعه چند مرکزی، 280 زن نابارور در معرض سندرم تحریک بیش از حد تخمدان پس از توجیه شدن در مورد شرایط مطالعه و اخذ رضایت آگاهانه وارد مطاله شدند. تمام بیماران به صورت تصادفی به دو گروه تقسیم شدند. تصادفی سازی به صورت ساده، فردی و با استفاده از جدول اعداد تصادفی انجام شد.
    empty
    empty
    empty
    empty

  • Ethics committees

    #1
    255
    IRCT2016092224512N4

  • Primary outcomes

    #1
    Chemical pregnancy rate
    Clinical pregnancy rate
    حاملگی شیمیایی
    حاملگی کلینیکال
    14 days after embryo transfer
    7 weeks after embryo transfer
    14 روز پس از انتقال جنین
    7 هفته پس از انتقال جنین
    Beta-hCG using lab kit
    Fetal heart rate in ultra sonography
    اندازه گیری آزمایشگاهی Beta-hCG
    وجود قلب جنین در سونوگرافی

  • Secondary outcomes

    #1
    clinical pregnancy rate
    Chemical pregnancy rate
    حاملگی کلینیکال
    حاملگی شیمیایی
    7 weeks after embryo transfer
    14 days after embryo transfer
    7 هفته پس از انتقال جنین
    14 روز پس از انتقال جنین
    fetal heart rate in ultra sonography
    Beta-hCG using lab kit
    وجود قلب جنین در سونوگرافی
    اندازه گیری آزمایشگاهی Beta-hCG
    #2
    empty
    livebirth
    empty
    تولد زنده
    empty
    36 weeks after embryo transfer
    empty
    36 هفته پس از انتقال جنین
    empty
    A live-born baby
    empty
    تولد یک نوزاد زنده
    #3
    empty
    Ovarian hyperstimulation syndrome
    empty
    سندرم تحریک بیش از حد تخمدان
    empty
    During ovarian stimulation
    empty
    هر زمان طی پروسه تحریک تخمدان
    empty
    Measurement of serum anti mullerian hormone level and antral follicle count
    empty
    اندازه گیری انتی مولرین هورمون و شمارش فولیکولهای آنترال
    #4
    empty
    Perinatal outcome
    empty
    پیامدهای پس از تولد
    empty
    After live birth
    empty
    پس از تولد زنده
    empty
    weight measurement, prematurity status
    empty
    اندازه گیری وزن، میزان رسیدگی جنین

  • Intervention groups

    #1
    Intervention group: Freeze of all embryos according to embryo freezing standard protocol at the same cycle. Thaw all the embryos according to embryo thawing standard protocol and embryo transfer at the next cycle
    Intervention group 1: Freeze of all embryos according to embryo freezing standard protocol at the same cycle. Thaw all the embryos according to embryo thawing standard protocol and embryo transfer at the next cycle
    گروه مداخله: منجمد نمودن تمامی جنینها طبق پروتکل استاندارد انجماد جنین در همان سیکل ذوب نمودن تمامی جنینها طبق پروتکل استاندارد برگشت از فریز جنین و انتقال آنهادر سیکل بعدی
    گروه مداخله 1: منجمد نمودن تمامی جنینها طبق پروتکل استاندارد انجماد جنین در همان سیکل ذوب نمودن تمامی جنینها طبق پروتکل استاندارد برگشت از فریز جنین و انتقال آنهادر سیکل بعدی
    #2
    Control group: Transfer of 2 fresh embryos at the same cycle Luteal phase support using oral Estradiol Valerat at the dose of 4 mg per day and progesterone (Cyclogest 400 mg) twice daily until observation of fetal heart activity
    Intervention group 2: Transfer of 2 fresh embryos at the same cycle Luteal phase support using oral Estradiol Valerat at the dose of 4 mg per day and progesterone (Cyclogest 400 mg) twice daily until observation of fetal heart activity
    گروه کنترل: انتقال دو جنین تازه در همان سیکل حمایت فاز لوتئال با استفاده از استرادیول والرات خوراکی با دوز ۴ میلی گرم در روز و پروژسترون به صورت شیاف سیکلوجست ۴۰۰ میلی گرمی دو بار در روز تا زمان مشاهده ضربان قلب جنین
    گروه مداخله 2: انتقال دو جنین تازه در همان سیکل حمایت فاز لوتئال با استفاده از استرادیول والرات خوراکی با دوز ۴ میلی گرم در روز و پروژسترون به صورت شیاف سیکلوجست ۴۰۰ میلی گرمی دو بار در روز تا زمان مشاهده ضربان قلب جنین

  • Recruitment centers

    #1
    Name of recruitment center - English: Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
    Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری، دانشگاه علوم پزشکی شهید صدوقی یزد
    Full name of responsible person - English: Nasim Tabibnejad
    Full name of responsible person - Persian: نسیم طبیب نژاد
    Street address - English: Bouali Ave, Safayieh
    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:
    Name of recruitment center - English: Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
    Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری، دانشگاه علوم پزشکی شهید صدوقی یزد
    Full name of responsible person - English: Nasim Tabibnejad
    Full name of responsible person - Persian: نسیم طبیب نژاد
    Street address - English: Bouali Ave, Safayieh
    Street address - Persian: صفاییه، خیابان بوعلی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 7085
    Fax:
    Email: nasimtabib@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Madar Hospital
    Name of recruitment center - Persian: بیمارستان مادر
    Full name of responsible person - English: Abbas Aflatoonian
    Full name of responsible person - Persian: عباس افلاطونیان
    Street address - English: Mahdieh Square
    Street address - Persian: میدان مهدیه
    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: Madar Hospital
    Name of recruitment center - Persian: بیمارستان مادر
    Full name of responsible person - English: Abbas Aflatoonian
    Full name of responsible person - Persian: عباس افلاطونیان
    Street address - English: Mahdieh Square
    Street address - Persian: میدان مهدیه
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3623 0030
    Fax:
    Email: info@madarhospital.com
    Web page address:
    #3
    Name of recruitment center - English: Novin Infertility Center
    Name of recruitment center - Persian: مرکز ناباروری نوین
    Full name of responsible person - English: Mahnaz Mansouri
    Full name of responsible person - Persian: مهناز منصوری
    Street address - English: 8th Kowsar Street, Kowsar BLVD
    Street address - Persian: بلوار کوثر، خیابان کوثر8
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Novin Infertility Center
    Name of recruitment center - Persian: مرکز ناباروری نوین
    Full name of responsible person - English: Mahnaz Mansouri
    Full name of responsible person - Persian: مهناز منصوری
    Street address - English: 8th Kowsar Street, Kowsar BLVD
    Street address - Persian: بلوار کوثر، خیابان کوثر8
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 5138833888
    Phone: +98 51 3883 3888
    Fax:
    Email: novinivf@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Research Deputy, Shahid Sadoughi University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهید صدوقی یزد
    Full name of responsible person - English: Amirhooshang Mehrparvar
    Full name of responsible person - Persian: امیر هوشنگ مهرپرور
    Street address - English: Bahonar Square
    Street address - Persian: میدان باهنر
    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: Research Deputy, Shahid Sadoughi University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهید صدوقی یزد
    Full name of responsible person - English: Amirhooshang Mehrparvar
    Full name of responsible person - Persian: امیر هوشنگ مهرپرور
    Street address - English: Bahonar Square
    Street address - Persian: میدان باهنر
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3724 0171
    Fax:
    Email: dvc.research@ssu.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
    Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری، دانشگاه علوم پزشکی شهید صدوقی یزد
    Full name of responsible person - English: Nasim Tabibnejad
    Full name of responsible person - Persian: نسیم طبیب نژاد
    Position - English: PhD student
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Safayieh
    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:
    Phone: +98 35 3824 8121
    Mobile: 00
    Fax:
    Email: nasimtabibnejad@ssu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
    Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری، دانشگاه علوم پزشکی شهید صدوقی یزد
    Full name of responsible person - English: Nasim Tabibnejad
    Full name of responsible person - Persian: نسیم طبیب نژاد
    Position - English: PhD student
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree: phd
    Area of specialty/work: 22
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Safayieh
    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 8121
    Mobile: +98 913 351 3186
    Fax:
    Email: nasimtabibnejad@ssu.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
    Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری دانشگاه علوم پزشکی شهید صدوقی
    Full name of responsible person - English: Abbas aflatoonian
    Full name of responsible person - Persian: عباس افلاطونیان
    Position - English: Gynecologist
    Position - Persian: متخصص زنان و مامایی، نازایی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Safayieh
    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:
    Phone: +98 35 3824 8121
    Mobile: 00
    Fax:
    Email: abbas-aflatoonian@ssu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
    Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری دانشگاه علوم پزشکی شهید صدوقی
    Full name of responsible person - English: Abbas aflatoonian
    Full name of responsible person - Persian: عباس افلاطونیان
    Position - English: Gynecologist
    Position - Persian: متخصص زنان و مامایی، نازایی
    Latest degree: specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Safayieh
    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 8121
    Mobile: +98 913 151 5349
    Fax:
    Email: abbas-aflatoonian@ssu.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
    Name of organization / entity - Persian: مزکز تحقیقاتی و درمانی ناباروری، دانشگاه علوم پزشکی شهید صدوقی یز
    Full name of responsible person - English: Nasim Tabibnejad
    Full name of responsible person - Persian: نسیم طبیب نژاد
    Position - English: PhD student
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Safayieh
    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: 8916816559
    Phone: +98 35 3824 8121
    Mobile: +98 913 351 3186
    Fax: +98 99683538247087
    Email: nasimtabibnejad@ssu.ac.ir
    Web page address: www.yazd-rsi.ir
    contact.organization_id:
    Name of organization / entity - English: Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
    Name of organization / entity - Persian: مزکز تحقیقاتی و درمانی ناباروری، دانشگاه علوم پزشکی شهید صدوقی یز
    Full name of responsible person - English: Nasim Tabibnejad
    Full name of responsible person - Persian: نسیم طبیب نژاد
    Position - English: PhD
    Position - Persian: دکترای تخصصی
    Latest degree: phd
    Area of specialty/work: 22
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Safayieh
    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: 8916816559
    Phone: +98 35 3824 8121
    Mobile: +98 913 351 3186
    Fax:
    Email: nasimtabibnejad@ssu.ac.ir
    Web page address:

  • Sharing plan

    yes
    yes
    yes
    yes
    yes
    yes
    yes
    empty
    All participant data sets are to be shared
    empty
    کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
    empty
    2 months after the result publication
    empty
    2 ماه بعد از چاپ نتایج
    empty
    A journal in which the results are published
    empty
    ژورنال چاپ کننده نتایج
    empty
    Submission of an official application via the agent that is legally in charge
    empty
    درخواست رسمی از طریق مرجع قانونی
    empty
    Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085 abbas_aflatoonian@yahoo.com
    empty
    پژوهشکده علوم تولید مثل یزد، خیابان بوعلی، یزد، ایران 983538247085 abbas_aflatoonian@yahoo.com
    empty
    2 months after application
    empty
    2 ماه پس از چاپ نتایج

Protocol summary

Study aim
Compare the reproductive outcomes of fresh vs frozen embryo transfer in high responder IVF patients triggered with GnRHa
Design
Women at risk for OHSS who were stimulated with GnRH antagonist protocol and triggered with GnRHa for oocyte triggering were randomly divided into two groups of either fresh embryo transfer or frozen embryo transfer on the day of oocyte triggering. In this not-blinded, phase 2 clinical trial without control group, randomization was performed using random number table.
Settings and conduct
In this multicenter, randomized clinical trial, infertile women at risk of OHSS were recruited at three fertility clinics in Iran; Yazd Research and Clinical Center for Infertility, Yazd Madar Hospital, Mashhad Novin Fertility and Infertility Center. Women were randomized into two groups. Pregnancy outcome were assessed in FET and fresh embryo transfer groups.
Participants/Inclusion and exclusion criteria
Patients with OHSS risk at the age between 20-40 yr and having a number of 14-25 follicles ≥12 mm on the day of trigger and a body mass index >18 and <35 kg/m2 without a previous history of OHSS development.
Intervention groups
Group 1: Women were stimulated with GnRH antagonist protocol and triggered with GnRHa for oocyte triggering with fresh embryo transfer Group 2: Women were stimulated with GnRH antagonist protocol and triggered with GnRHa for oocyte triggering with frozen embryo transfer
Main outcome variables
The primary outcome parameter was clinical pregnancy and the secondary outcome parameters were chemical pregnancy; live birth; OHSS development; and perinatal outcomes.

General information

Reason for update
Updating the trial regarding actual sample size, actual recruitment start and end dates
Acronym
IRCT registration information
IRCT registration number: IRCT2016092224512N4
Registration date: 2016-10-03, 1395/07/12
Registration timing: retrospective

Last update: 2021-03-24, 1400/01/04
Update count: 1
Registration date
2016-10-03, 1395/07/12
Registrant information
Name
Abbas Aflatoonian
Name of organization / entity
Yazd research and clinical center for infertility
Country
Iran (Islamic Republic of)
Phone
+98 358247085
Email address
abbas-aflatoonian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy, Shahid Sadoughi Univesity of Medical Science
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2015-12-30, 1394/10/09
Actual recruitment start date
2014-01-01, 1392/10/11
Actual recruitment end date
2015-12-30, 1394/10/09
Trial completion date
2017-01-30, 1395/11/11
Scientific title
Comparison of Fresh and Frozen Embryo Transfer in GnRH Agonist Triggered patients: A Multicenter Study
Public title
Pregnancy outcome in Fresh versus Freeze embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-40 Hyper responded patients Detection of 14-25 follicles ≥ 12 mm on day of trigger BMI >18 and <35 kg/m2
Exclusion criteria:
Patients with <14 follicles and > 25 ≥ 12 mm on day of trigge Previous OHSS Endocrine disorders
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 1280
Actual sample size reached: 280
Randomization (investigator's opinion)
Randomized
Randomization description
In this multicenter, randomized clinical trial, 280 infertile women at risk of OHSS were enrolled in the study. All patients were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual using a random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
Street address
Bouali Ave, Safayieh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2013-12-09, 1392/09/18
Ethics committee reference number
IRCT2016092224512N4

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
inability to achieve a pregnancy sterility, female NOS

Primary outcomes

1

Description
Clinical pregnancy rate
Timepoint
7 weeks after embryo transfer
Method of measurement
Fetal heart rate in ultra sonography

Secondary outcomes

1

Description
Chemical pregnancy rate
Timepoint
14 days after embryo transfer
Method of measurement
Beta-hCG using lab kit

2

Description
livebirth
Timepoint
36 weeks after embryo transfer
Method of measurement
A live-born baby

3

Description
Ovarian hyperstimulation syndrome
Timepoint
During ovarian stimulation
Method of measurement
Measurement of serum anti mullerian hormone level and antral follicle count

4

Description
Perinatal outcome
Timepoint
After live birth
Method of measurement
weight measurement, prematurity status

Intervention groups

1

Description
Intervention group 1: Freeze of all embryos according to embryo freezing standard protocol at the same cycle. Thaw all the embryos according to embryo thawing standard protocol and embryo transfer at the next cycle
Category
Treatment - Other

2

Description
Intervention group 2: Transfer of 2 fresh embryos at the same cycle Luteal phase support using oral Estradiol Valerat at the dose of 4 mg per day and progesterone (Cyclogest 400 mg) twice daily until observation of fetal heart activity
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
Full name of responsible person
Nasim Tabibnejad
Street address
Bouali Ave, Safayieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
nasimtabib@yahoo.com

2

Recruitment center
Name of recruitment center
Madar Hospital
Full name of responsible person
Abbas Aflatoonian
Street address
Mahdieh Square
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3623 0030
Email
info@madarhospital.com

3

Recruitment center
Name of recruitment center
Novin Infertility Center
Full name of responsible person
Mahnaz Mansouri
Street address
8th Kowsar Street, Kowsar BLVD
City
Mashhad
Province
Razavi Khorasan
Postal code
5138833888
Phone
+98 51 3883 3888
Email
novinivf@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amirhooshang Mehrparvar
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, 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
Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
Full name of responsible person
Nasim Tabibnejad
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Bouali Ave, Safayieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8121
Fax
Email
nasimtabibnejad@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
Full name of responsible person
Abbas aflatoonian
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safayieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8121
Fax
Email
abbas-aflatoonian@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
Full name of responsible person
Nasim Tabibnejad
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Bouali Ave, Safayieh
City
Yazd
Province
Yazd
Postal code
8916816559
Phone
+98 35 3824 8121
Fax
Email
nasimtabibnejad@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, Bouali Ave, Yazd, Iran. 983538247085 abbas_aflatoonian@yahoo.com
What processes are involved for a request to access data/document
2 months after application
Comments
Loading...