Efficacy of low-dose human chorionic gonadotropin in late follicular phase of controlled ovarian stimulation using GnRH agonist protocol among infertile women undergoing assisted reproductive technology
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Protocol summary
This prospective study evaluates the effect of low dose human chorionic gonadotropin injection in late follicular phase instead of gonadotropins administration in agonist long protocol. This randomized controlled trial includes 122 patients, who are going to have assisted reproductive technology treatment. Patients are randomly divided into two groups. Their ages are less than 38 years old with regular menstrual cycle (25-35 days) and BMI less than 30 kg/m 2. Exclusion criteria are severe endometriosis, PCOS, history of pelvic surgery and azoospermia. The control group receive standard long protocol. The study group (n=60) receive GnRH long protocol. They receive 200 IU HCG instead of HMG when they have more than 6 follicles with mean diameter more than 12 mm. Primary outcome is chemical pregnancy, which is defined by positive beta–hCG 12 days after embryos transfer.
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This prospective study evaluates the effect of low dose human chorionic gonadotropin injection in late follicular phase instead of gonadotropins administration in agonist long protocol. This randomized controlled trial includes 122 patients, who are going to have assisted reproductive technology treatment. Patients are randomly divided into two groups. Their ages are less than 38 years old with regular menstrual cycle (25-35 days) and BMI less than 30 kg/m 2. Exclusion criteria are severe endometriosis, PCOS, history of pelvic surgery and azoospermia. The control group receive standard long protocol. The study group (n=60) receive GnRH long protocol. They receive 200 IU HCG instead of HMG when they have more than 6 follicles with mean diameter more than 12 mm. Primary outcome is chemical pregnancy, which is defined by positive beta–hCG 12 days after embryos transfer.
هدف از این مطالعه آینده نگر بررسی دوز کم کوریونیک گونادوتروپین انسانی در فاز انتهایی فولیکولار میتواند به جای گنادوتروپین میباشد.این مطالعه کارازمایی راندوم شده است و در 122 بیمار که کاندید استفاده از روش کمک باروری بودند انجام میشود .بیماران با سن کمتر از 38 ؛سیکل طبیعی (25-35) روز؛ شاخص توده بدن کمتر از 30 در این مطالعه شرکت میکنند.کرایتریای خروج شامل : اندومتریوز شدید ؛ PCOS؛ تاریخچه عمل جراحی لگن وآ زواسپرمی میباشد.گروه کنترل (تعداد 60 نفر)روش استاندارد پروتکل اگونیست طولانی را دریافت کردند . در گروه کنترل (تعداد 60 نفر)پروتکل اگونیست طولانی را دریافت میکننداما وقتی که بیشتر از6 فولیکول با قطر بیشتر از12 میلیمتر در دو تخمدان داشتند ، گنادوتروپین با 200 واحد هورمون کوریونیک گنادوتروپین جایگزین میشود.پیامد اولیه حاملگی شیمیایی است و به صورت B HCGمثبت دو هفته بعد از انتقال جنین تعریف شد.
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هدف از این مطالعه آینده نگر بررسی دوز کم کوریونیک گونادوتروپین انسانی در فاز انتهایی فولیکولار میتواند به جای گنادوتروپین میباشد.این مطالعه کارازمایی راندوم شده است و در 122 بیمار که کاندید استفاده از روش کمک باروری بودند انجام میشود .بیماران با سن کمتر از 38 ؛سیکل طبیعی (25-35) روز؛ شاخص توده بدن کمتر از 30 در این مطالعه شرکت میکنند.کرایتریای خروج شامل : اندومتریوز شدید ؛ PCOS؛ تاریخچه عمل جراحی لگن وآ زواسپرمی میباشد.گروه کنترل (تعداد 60 نفر)روش استاندارد پروتکل اگونیست طولانی را دریافت کردند . در گروه کنترل (تعداد 60 نفر)پروتکل اگونیست طولانی را دریافت میکننداما وقتی که بیشتر از6 فولیکول با قطر بیشتر از12 میلیمتر در دو تخمدان داشتند ، گنادوتروپین با 200 واحد هورمون کوریونیک گنادوتروپین جایگزین میشود.پیامد اولیه حاملگی شیمیایی است و به صورت B HCGمثبت دو هفته بعد از انتقال جنین تعریف شد.
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The effectiveness of using a low-dose hCG supplementation in comparison with a GnRH agonist in the late follicular phase.
The effectiveness of using a low-dose hCG supplementation in comparison with a GnRH agonist in the late follicular phase.
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بررسی تاثیر استفاده از دوز کم کوریونیک گونادوتروپین انسانی در مقایسه با آگونیست GnRH در فاز انتهایی فولیکولار
بررسی تاثیر استفاده از دوز کم کوریونیک گونادوتروپین انسانی در مقایسه با آگونیست GnRH در فاز انتهایی فولیکولار
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Intervention 2: Ovarian stimulation with human menopausal gonadotropin was started from day 2 of cycle. Ovarian response was monitored by serial vaginal sonographies and evaluation of serum E2 levels. Patients received hMG until the end of ovarian stimulation.
Intervention 2: Ovarian stimulation with human menopausal gonadotropin was started from day 2 of cycle. Ovarian response was monitored by serial vaginal sonographies and evaluation of serum E2 levels. Patients received hMG until the end of ovarian stimulation.
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مداخله 2: تحریک تخمدان به وسیله گونادوترپین مونوپوزال انسانی از روز دوم سیکل آغاز شد. پاسخ تخمدان به تحریک بوسیله سونوگرافی های واژینال مرتب و همچنین اندازه گیری استرادیول خون پایش شد. گونادوترپین مونوپوزال انسانی تا آخر پروسه تحریک تخمدان برای بیماران تجویز شد.
مداخله 2: تحریک تخمدان به وسیله گونادوترپین مونوپوزال انسانی از روز دوم سیکل آغاز شد. پاسخ تخمدان به تحریک بوسیله سونوگرافی های واژینال مرتب و همچنین اندازه گیری استرادیول خون پایش شد. گونادوترپین مونوپوزال انسانی تا آخر پروسه تحریک تخمدان برای بیماران تجویز شد.
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Women younger than 38 years old who scheduled for ART were randomly divided into two groups of either hCG or hMG. In this not-blinded, phase 2 clinical trial without control group, randomization was performed using random number table.
Women younger than 38 years old who scheduled for ART were randomly divided into two groups of either hCG or hMG. In this not-blinded, phase 2 clinical trial without control group, randomization was performed using random number table.
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زنان زیر 38 سال که کاندید انجام ART بودند به صورت راندوم به دو گروه گونادوترپین کوریونیک انسانی و یا گونادوترپین مونوپوزال انسانی تقسیم شدند. در این کارازمایی بالینی بدون کورسازی فاز 2 بدون گروه کنترل، تصادفی سازی به وسیله جدول اعداد تصادفی انجام شد.
زنان زیر 38 سال که کاندید انجام ART بودند به صورت راندوم به دو گروه گونادوترپین کوریونیک انسانی و یا گونادوترپین مونوپوزال انسانی تقسیم شدند. در این کارازمایی بالینی بدون کورسازی فاز 2 بدون گروه کنترل، تصادفی سازی به وسیله جدول اعداد تصادفی انجام شد.
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All women younger than 38 years old, with regular menstrual cycles ,BMI\30 kg/m2, normal uterus and ovaries in vaginal ultrasound and basal FSH\10 IU/L were included .
Women with severe endometriosis, polycystic ovary syndrome (PCOS), history of pelvic surgery, azoospermia and more than two in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle failures were excluded from the study.
All women younger than 38 years old, with regular menstrual cycles ,BMI\30 kg/m2, normal uterus and ovaries in vaginal ultrasound and basal FSH\10 IU/L were included . Women with severe endometriosis, polycystic ovary syndrome (PCOS), history of pelvic surgery, azoospermia and more than two in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle failures were excluded from the study.
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زنان کمتر از 38 سال سن با قاعدگی منظم و شاخص توده بدنی زیر 30، با رحم و تخمدانهای نرمال در سونوگرافی واژینال و FSH پایه زیر 10 وارد مطالعه شدند.
زنان با اندومتریوز شدید، سندرم تخمدان پلی کیستیک، سابقه جراحی لگن، آزوسپرمی و سابقه بیش از دو بار شکست IVF و یا ICSI قبلی از مطالعه خارج شدند.
زنان کمتر از 38 سال سن با قاعدگی منظم و شاخص توده بدنی زیر 30، با رحم و تخمدانهای نرمال در سونوگرافی واژینال و FSH پایه زیر 10 وارد مطالعه شدند. زنان با اندومتریوز شدید، سندرم تخمدان پلی کیستیک، سابقه جراحی لگن، آزوسپرمی و سابقه بیش از دو بار شکست IVF و یا ICSI قبلی از مطالعه خارج شدند.
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Intervention 1: Ovarian stimulation with human menopausal gonadotropin was started from day 2 of cycle. Ovarian response was monitored by serial vaginal sonographies and evaluation of serum E2 levels. The administration of hMG was discontinued when at least six follicles >12 mm were observed and E2 levels were higher than 600 pg/ml; hMG was replaced by 200 IU per day of hCG until final follicular maturation.
Intervention 1: Ovarian stimulation with human menopausal gonadotropin was started from day 2 of cycle. Ovarian response was monitored by serial vaginal sonographies and evaluation of serum E2 levels. The administration of hMG was discontinued when at least six follicles >12 mm were observed and E2 levels were higher than 600 pg/ml; hMG was replaced by 200 IU per day of hCG until final follicular maturation.
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مداخله 1: تحریک تخمدان به وسیله گونادوترپین مونوپوزال انسانی از روز دوم سیکل آغاز شد. پاسخ تخمدان به تحریک بوسیله سونوگرافی های واژینال مرتب و همچنین اندازه گیری استرادیول خون پایش شد. وقتی حداقل 6 فولیکول بیش از 12 میلی متر دیده شد و سطح استرادیول خون به بیش از 600 پیکوگرم در میلی لیتر رسید،تجویز گونادوترپین مونوپوزال انسانی قطع شد و با گونادوترپین کوریونیک انسانی به میزان 200 واحد در روز جایگزین شد که تا بلوغ نهایی فولیکولها ادامه پیدا کرد.
مداخله 1: تحریک تخمدان به وسیله گونادوترپین مونوپوزال انسانی از روز دوم سیکل آغاز شد. پاسخ تخمدان به تحریک بوسیله سونوگرافی های واژینال مرتب و همچنین اندازه گیری استرادیول خون پایش شد. وقتی حداقل 6 فولیکول بیش از 12 میلی متر دیده شد و سطح استرادیول خون به بیش از 600 پیکوگرم در میلی لیتر رسید،تجویز گونادوترپین مونوپوزال انسانی قطع شد و با گونادوترپین کوریونیک انسانی به میزان 200 واحد در روز جایگزین شد که تا بلوغ نهایی فولیکولها ادامه پیدا کرد.
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Chemical pregnancy
Chemical pregnancy
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حاملگی شیمیایی
حاملگی شیمیایی
General information
2-3
2
2-3
120
130
120130
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122
122
2009-01-01, 1387/10/12
2009-03-01, 1387/12/11
2009-0103-01 00:00:00
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2009-03-01, 1387/12/11
2009-03-01 00:00:00
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2010-09-30, 1389/07/08
2010-09-30 00:00:00
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2011-05-01, 1390/02/11
2011-05-01 00:00:00
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Updating the trial regarding actual sample size, actual recruitment start and end dates
Updating the trial regarding actual sample size, actual recruitment start and end dates
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به روزرسانی کارآزمایی بالینی در مورد تعداد نمونه نهایی، تاریخ دقیق شروع و پایان بیمارگیری
به روزرسانی کارآزمایی بالینی در مورد تعداد نمونه نهایی، تاریخ دقیق شروع و پایان بیمارگیری
Efficacy of low-dose human chorionic gonadotropin in late follicular phase in controlled ovarian stimulation in GnRH agonist protocol in infertile women undergoing assisted reproductive technology
Efficacy of low-dose human chorionic gonadotropin in late follicular phase of controlled ovarian stimulation using GnRH agonist protocol among infertile women undergoing assisted reproductive technology
Efficacy of low-dose human chorionic gonadotropin in late follicular phase inof controlled ovarian stimulation inusing GnRH agonist protocol inamong infertile women undergoing assisted reproductive technology
Age<38 years
Regular menstrual cycle (25-35 days)
BMI <30 kg/m 2
Normal uterus and ovaries in vaginal ultrasound
FSH<10IU/L
Age<38 years Regular menstrual cycle (25-35 days) BMI <30 kg/m 2 Normal uterus and ovaries in vaginal ultrasound FSH<10IU/L
سن کمتر از 38 سال
قاعدگی منظم (35-25 روز)
شاخص توده بدن بیشتر از 30
رحم وتخمدان نرمال در سونوگرافی واژینال
FSHکمتر از 10
سن کمتر از 38 سال قاعدگی منظم (35-25 روز) شاخص توده بدن بیشتر از 30 رحم وتخمدان نرمال در سونوگرافی واژینال FSHکمتر از 10
Severe endometriosis
Polycystic ovarian syndrome
History of pelvic surgery
Azoospermia
More than two IVF or ICSI cycle failures
Severe endometriosis Polycystic ovarian syndrome History of pelvic surgery Azoospermia More than two IVF or ICSI cycle failures
In this trial, infertile women who were scheduled for ART and met the inclusion criteria, informed about the research design and signed a written consent form for randomly assignment either to case or control groups. All women were randomly divided into two groups using simple, individual through random number table. All women were consecutively assigned into two groups based on randomized list.
In this trial, infertile women who were scheduled for ART and met the inclusion criteria, informed about the research design and signed a written consent form for randomly assignment either to case or control groups. All women were randomly divided into two groups using simple, individual through random number table. All women were consecutively assigned into two groups based on randomized list.
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در این مطالعه زنان کاندید ART و دارای شرایط ورود به مطالعه از نظر روش انجام طرح توجیه شدند و رضایت آگاهانه برای قرارگرفتن در هر یک از دو گروه مورد مطالعه به صورت تصادفی از آنها اخذ گردید. تصادفی سازی به صورت ساده، فردی و با استفاده از جدول اعداد تصادفی انجام شد. افراد به ترتیب مراجعه و با استفاده از لیست تصادفی سازی شده به دو گروه مورد نظر تخصیص یافتند.
در این مطالعه زنان کاندید ART و دارای شرایط ورود به مطالعه از نظر روش انجام طرح توجیه شدند و رضایت آگاهانه برای قرارگرفتن در هر یک از دو گروه مورد مطالعه به صورت تصادفی از آنها اخذ گردید. تصادفی سازی به صورت ساده، فردی و با استفاده از جدول اعداد تصادفی انجام شد. افراد به ترتیب مراجعه و با استفاده از لیست تصادفی سازی شده به دو گروه مورد نظر تخصیص یافتند.
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Primary outcomes
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chemical pregnancy
Chemical pregnancy
chemicalChemical pregnancy
Secondary outcomes
#1
clinical pregnancy
Clinical pregnancy
clinicalClinical pregnancy
2week
7 weeks after embryo transfer
2week7 weeks after embryo transfer
2 هفته
7 هفته پس از انتقال جنین
27 هفته پس از انتقال جنین
sonography
Sonography
sonographySonography
Recruitment centers
#1
Name of recruitment center - English: Yazd reserch and clinical center for infertility
Name of recruitment center - Persian: مرکز تحقیقاتی درمانی ناباروری یزد
Full name of responsible person - English: Dr Maryam Eftekhar
Full name of responsible person - Persian: دکتر مریم افتخار
Street address - English: Boali street, Safaieh
Street address - Persian: يزد- صفائيه-خ بوعلي- مركز تحقيقاتي درماني ناباروري يزد
City - English: Yazd
City - Persian: یزد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Yazd reserch and clinical center for infertility
Name of recruitment center - Persian: مرکز تحقیقاتی درمانی ناباروری یزد
Full name of responsible person - English: Dr Maryam Eftekhar
Full name of responsible person - Persian: دکتر مریم افتخار
Street address - English: Boali street, Safaieh
Street address - Persian: يزد- صفائيه-خ بوعلي- مركز تحقيقاتي درماني ناباروري يزد
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Fax:
Email: eftekhar@ssu.ac.ir
Web page address:
Name of recruitment center - English: Yazd reserch and clinical center for infertility Name of recruitment center - Persian: مرکز تحقیقاتی درمانی ناباروری یزد Full name of responsible person - English: Dr Maryam Eftekhar Full name of responsible person - Persian: دکتر مریم افتخار Street address - English: Boali street, Safaieh Street address - Persian: يزد- صفائيه-خ بوعلي- مركز تحقيقاتي درماني ناباروري يزد City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Fax: Email: eftekhar@ssu.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Research and Clinical Center for Infertility
Name of organization / entity - Persian: مرکزتحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Dr. Abbas Aflatoonain
Full name of responsible person - Persian: دكتر عباس افلاطونيان
Street address - English: Bouali Ave, Safayeh
Street address - Persian: یزد صفاییه ،خیابان بوعلی، مرکزتحقیقاتی و درمانی ناباروری یزد
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: Deputy of Research and technology, Yazd Shahid Sadoughi Medical Sciences
Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Masoud Mirzaei
Full name of responsible person - Persian: مسعود میرزایی
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:
contact.organization_id: Name of organization / entity - English: Deputy of Research and Clinical Center for Infertilitytechnology, Yazd Shahid Sadoughi Medical Sciences Name of organization / entity - Persian: مرکزتحقیقاتیمعاونت تحقیقات و درمانی ناباروریفناوری دانشگاه علوم پزشکی شهید صدوقی یزد Full name of responsible person - English: Dr. Abbas AflatoonainMasoud Mirzaei Full name of responsible person - Persian: دكتر عباس افلاطونيانمسعود میرزایی Street address - English: Bouali Ave, SafayehBahonar square Street address - Persian: یزد صفاییه ،خیابان بوعلی، مرکزتحقیقاتی و درمانی ناباروری یزدمیدان 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:
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Public
public
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Domestic
domestic
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Academic
academic
Research and Clinical Center for Infertility
Deputy of Research and Technology, Yazd Shahid Sadoughi Medical Sciences
Deputy of Research and Clinical Center for InfertilityTechnology, Yazd Shahid Sadoughi Medical Sciences
مرکزتحقیقاتی و درمانی ناباروری یزد
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید صدوقی یزد
مرکزتحقیقاتیمعاونت تحقیقات و درمانی ناباروریفناوری دانشگاه علوم پزشکی شهید صدوقی یزد
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Research and Clinical Center for Infertility
Name of organization / entity - Persian: مرکز تحقیقاتی درمانی یزد
Full name of responsible person - English: Dr Maryam Eftekhar
Full name of responsible person - Persian: دکتر مریم افتخار
Position - English: Assisted professor of Obstetrics and Gynecology
Position - Persian: استاديار گروه زنان دانشگاه علوم پزشكي يزد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bouali Ave, Safayeh
Street address - Persian: يزد- صفائيه- خ بوعلي-مرکزتحقیقاتی و درمانی ناباروری یزد
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 1824 7085
Mobile:
Fax:
Email: eftekhar@ssu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Research and Clinical Center for Infertility
Name of organization / entity - Persian: مرکز تحقیقاتی درمانی یزد
Full name of responsible person - English: Dr Maryam Eftekhar
Full name of responsible person - Persian: دکتر مریم افتخار
Position - English: Assisted Professor of Obstetrics and Gynecology
Position - Persian: استاديار گروه زنان دانشگاه علوم پزشكي يزد
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, Safayeh
Street address - Persian: يزد- صفائيه- خ بوعلي-مرکزتحقیقاتی و درمانی ناباروری یزد
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 1824 7085
Mobile: +98 913 156 3078
Fax:
Email: eftekhar@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Research and Clinical Center for Infertility Name of organization / entity - Persian: مرکز تحقیقاتی درمانی یزد Full name of responsible person - English: Dr Maryam Eftekhar Full name of responsible person - Persian: دکتر مریم افتخار Position - English: Assisted professorProfessor of Obstetrics and Gynecology Position - Persian: استاديار گروه زنان دانشگاه علوم پزشكي يزد Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Bouali Ave, Safayeh Street address - Persian: يزد- صفائيه- خ بوعلي-مرکزتحقیقاتی و درمانی ناباروری یزد 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 1824 7085 Mobile: +98 913 156 3078 Fax: Email: eftekhar@ssu.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Yazd Research and Clinical Center for infertility
Name of organization / entity - Persian: دکتر مریم افتخار
Full name of responsible person - English: Dr Maryam Eftekhar
Full name of responsible person - Persian: 00983518248348
Position - English: Assisted professor of Obstetrics and Gynecology
Position - Persian: استادیار زنان دانشگاه علوم پزشکی شهید صدوقی یزد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Re Bouali Ave, Safayeh
Street address - Persian: يزد- صفائيه- خ بوعلي-مرکزتحقیقاتی و درمانی ناباروری یزد
City - English: Yazd
City - Persian: یزد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 913 156 3078
Mobile:
Fax:
Email: eftekhar@ssu.ac.ireftekharmaryam@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Yazd Research and Clinical Center for Infertility
Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Dr Maryam Eftekhar
Full name of responsible person - Persian: مریم افتخار
Position - English: Assisted Professor of Obstetrics and Gynecology
Position - Persian: استادیار زنان دانشگاه علوم پزشکی شهید صدوقی یزد
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, Safayeh
Street address - Persian: يزد- صفائيه- خ بوعلي-مرکزتحقیقاتی و درمانی ناباروری یزد
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: +98 913 156 3078
Mobile: +98 913 156 3078
Fax:
Email: eftekhar@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Yazd Research and Clinical Center for infertilityInfertility Name of organization / entity - Persian: دکتر مریم افتخارمرکز تحقیقاتی و درمانی ناباروری یزد Full name of responsible person - English: Dr Maryam Eftekhar Full name of responsible person - Persian: 00983518248348مریم افتخار Position - English: Assisted professorProfessor of Obstetrics and Gynecology Position - Persian: استادیار زنان دانشگاه علوم پزشکی شهید صدوقی یزد Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Re Bouali Ave, Safayeh Street address - Persian: يزد- صفائيه- خ بوعلي-مرکزتحقیقاتی و درمانی ناباروری یزد 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: +98 913 156 3078 Mobile: +98 913 156 3078 Fax: Email: eftekhar@ssu.ac.ireftekharmaryam@yahoo.comssu.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: مرکر تحقیقاتی درمانی نلباروری یزد
Full name of responsible person - English: Dr Maryam Eftekhar
Full name of responsible person - Persian: دکتر مریم افتخار
Position - English: Assisted professor of Obstetrics and Gynecology
Position - Persian: استادیار گروه زنان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Research and Clinical Center for Infertility, Bouali Ave, Safayeh
Street address - Persian: یزد ، صفاییه ، خیابان بوعلی ،مرکز تحقیقات ناباروری
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 1824 8348
Mobile: +98 913 156 3078
Fax:
Email: eftekhar@ssu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Yazd Research and Clinical Center for Infertility
Name of organization / entity - Persian: مرکر تحقیقاتی درمانی ناباروری یزد
Full name of responsible person - English: Dr Maryam Eftekhar
Full name of responsible person - Persian: دکتر مریم افتخار
Position - English: Assisted Professor of Obstetrics and Gynecology
Position - Persian: استادیار گروه زنان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Research and Clinical Center for Infertility, Bouali Ave, Safayeh
Street address - Persian: یزد ، صفاییه ، خیابان بوعلی ،مرکز تحقیقات ناباروری
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 1824 8348
Mobile: +98 913 156 3078
Fax:
Email: eftekhar@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Yazd reaserchResearch and clinical centerClinical Center for infertilityInfertility Name of organization / entity - Persian: مرکر تحقیقاتی درمانی نلباروریناباروری یزد Full name of responsible person - English: Dr Maryam Eftekhar Full name of responsible person - Persian: دکتر مریم افتخار Position - English: Assisted professorProfessor of Obstetrics and Gynecology Position - Persian: استادیار گروه زنان Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Research and Clinical Center for Infertility, Bouali Ave, Safayeh Street address - Persian: یزد ، صفاییه ، خیابان بوعلی ،مرکز تحقیقات ناباروری 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 1824 8348 Mobile: +98 913 156 3078 Fax: Email: eftekhar@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
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
Protocol summary
Study aim
The effectiveness of using a low-dose hCG supplementation in comparison with a GnRH agonist in the late follicular phase.
Design
Intervention 2: Ovarian stimulation with human menopausal gonadotropin was started from day 2 of cycle. Ovarian response was monitored by serial vaginal sonographies and evaluation of serum E2 levels. Patients received hMG until the end of ovarian stimulation.
Settings and conduct
Women younger than 38 years old who scheduled for ART were randomly divided into two groups of either hCG or hMG. In this not-blinded, phase 2 clinical trial without control group, randomization was performed using random number table.
Participants/Inclusion and exclusion criteria
All women younger than 38 years old, with regular menstrual cycles ,BMI\30 kg/m2, normal uterus and ovaries in vaginal ultrasound and basal FSH\10 IU/L were included .
Women with severe endometriosis, polycystic ovary syndrome (PCOS), history of pelvic surgery, azoospermia and more than two in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle failures were excluded from the study.
Intervention groups
Intervention 1: Ovarian stimulation with human menopausal gonadotropin was started from day 2 of cycle. Ovarian response was monitored by serial vaginal sonographies and evaluation of serum E2 levels. The administration of hMG was discontinued when at least six follicles >12 mm were observed and E2 levels were higher than 600 pg/ml; hMG was replaced by 200 IU per day of hCG until final follicular maturation.
Main outcome variables
Chemical pregnancy
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:IRCT201107286420N5
Registration date:2011-09-01, 1390/06/10
Registration timing:retrospective
Last update:2021-04-10, 1400/01/21
Update count:1
Registration date
2011-09-01, 1390/06/10
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd research and clinical center for infertility
Expected recruitment start date
2009-03-01, 1387/12/11
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
2009-03-01, 1387/12/11
Actual recruitment end date
2010-09-30, 1389/07/08
Trial completion date
2011-05-01, 1390/02/11
Scientific title
Efficacy of low-dose human chorionic gonadotropin in late follicular phase of controlled ovarian stimulation using GnRH agonist protocol among infertile women undergoing assisted reproductive technology
Public title
Comparison of two protocols for controlled ovarian stimulation in infertile women undergoing assisted reproductive technology
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age<38 years
Regular menstrual cycle (25-35 days)
BMI <30 kg/m 2
Normal uterus and ovaries in vaginal ultrasound
FSH<10IU/L
Exclusion criteria:
Severe endometriosis
Polycystic ovarian syndrome
History of pelvic surgery
Azoospermia
More than two IVF or ICSI cycle failures
Age
From 18 years old to 38 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
130
Actual sample size reached:
122
Randomization (investigator's opinion)
Randomized
Randomization description
In this trial, infertile women who were scheduled for ART and met the inclusion criteria, informed about the research design and signed a written consent form for randomly assignment either to case or control groups. All women were randomly divided into two groups using simple, individual through random number table. All women were consecutively assigned into two groups based on randomized list.
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
Yazd Research and Clinical Center for Infertility
Street address
Bouali Ave, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2010-11-10, 1389/08/19
Ethics committee reference number
2310
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
2 weeks
Method of measurement
BHCG serum
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
7 weeks after embryo transfer
Method of measurement
Sonography
Intervention groups
1
Description
The control group (n=62) receive standard long protocol and gonadotropins administration continue until the day of hCG injection (10000 IU) for final follicular maturation.
Category
Treatment - Drugs
2
Description
The study group (n=60) receive GnRH long protocol. They receive 200 IU HCG instead of HMG when they have more than 6 follicles with mean diameter more than 12 mm.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd reserch and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Street address
Boali street, Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekhar@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and technology, Yazd Shahid Sadoughi Medical Sciences
Full name of responsible person
Masoud Mirzaei
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
Deputy of Research and Technology, Yazd Shahid Sadoughi 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
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 913 156 3078
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 8348
Fax
Email
eftekhar@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
A journal in which the results are published
What processes are involved for a request to access data/document
Submission of an official application via the agent that is legally in charge