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Protocol summary
The aim of this prospective, randomized controlled study is Evaluation of effect of endometrial injury on pregnancy rate in frozen- thawed embryo transfer .
Inclusion criteria: Infertile patients candidate for frozen- thawed embryo transfer .
Exclusion criteria: women older than 40 years; women with history of endocrine disorders; intrauterine abnormality (uterine polyp, sub mucosal fibroma, intrauterine adhesion)and severe endometriosis . In intervention group (50 patients)in cycle 21-23 days (before embryo transfer cycle) ,the edometrium is scratched with piple .No intervention in control group is done.At the end, chemical and clinical pregnancy rates will be evaluated in intervention and control groups.
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The aim of this prospective, randomized controlled study is Evaluation of effect of endometrial injury on pregnancy rate in frozen- thawed embryo transfer . Inclusion criteria: Infertile patients candidate for frozen- thawed embryo transfer . Exclusion criteria: women older than 40 years; women with history of endocrine disorders; intrauterine abnormality (uterine polyp, sub mucosal fibroma, intrauterine adhesion)and severe endometriosis . In intervention group (50 patients)in cycle 21-23 days (before embryo transfer cycle) ,the edometrium is scratched with piple .No intervention in control group is done.At the end, chemical and clinical pregnancy rates will be evaluated in intervention and control groups.
این مطالعه یک مطالعه اینده نگر و تصادفی شده و کور نشده می باشد. روش راندومیزیشن،ایجاد اعداد تصادفی شده بوسیله کامپیوتر بوده است.
هدف از این مطالعه، بررسی تاثیر خراش اندومتر بر روی نتایج حاملگی در سیکل برگشت از فریز می باشد.
معیارهای ورود: بیماران نابارور که کاندید سیکل برگشت از فریز می باشند.
معیارهای خروج: زنان مسن تراز40سال،
سابقه بیماریهای اندوکرین، ضایعات داخل رحمی(میوم ،پولیپ، چسبندگی)، سابقه اندومتریوز شدید می باشد.
بیماران به طور تصادفی به دو گروه مداخله و گروه کنترل تقسیم می شوند.
بیماران در گروه مداخله در روز 23-21 سیکل بلافاصله قبل از سیکل برگشت از فریز تحت خراش اندومتربا piple قرار می گیرند.
بیماران در گروه کنترل در سیکل قبل از درمان تحت هیچ اقدامی قرار نمی گیرند.
در اخر حاملگی شیمیایی و حاملگی کلینیکی در گروه مداخله با کنترل مقایسه خواهد شد.
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این مطالعه یک مطالعه اینده نگر و تصادفی شده و کور نشده می باشد. روش راندومیزیشن،ایجاد اعداد تصادفی شده بوسیله کامپیوتر بوده است. هدف از این مطالعه، بررسی تاثیر خراش اندومتر بر روی نتایج حاملگی در سیکل برگشت از فریز می باشد. معیارهای ورود: بیماران نابارور که کاندید سیکل برگشت از فریز می باشند. معیارهای خروج: زنان مسن تراز40سال، سابقه بیماریهای اندوکرین، ضایعات داخل رحمی(میوم ،پولیپ، چسبندگی)، سابقه اندومتریوز شدید می باشد. بیماران به طور تصادفی به دو گروه مداخله و گروه کنترل تقسیم می شوند. بیماران در گروه مداخله در روز 23-21 سیکل بلافاصله قبل از سیکل برگشت از فریز تحت خراش اندومتربا piple قرار می گیرند. بیماران در گروه کنترل در سیکل قبل از درمان تحت هیچ اقدامی قرار نمی گیرند. در اخر حاملگی شیمیایی و حاملگی کلینیکی در گروه مداخله با کنترل مقایسه خواهد شد.
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Whether endometrial injury in luteal phase prior to FET cycle would improve pregnancy outcomes
Whether endometrial injury in luteal phase prior to FET cycle would improve pregnancy outcomes
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آیا خراش اندومتر در فاز لوتئال قبل از انتقال جنین فریز حاملگی را بهبود می بخشد
آیا خراش اندومتر در فاز لوتئال قبل از انتقال جنین فریز حاملگی را بهبود می بخشد
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Women who were candidate for FET were randomly divided into two groups of either endometrial injury before embryo transfer or no endometrial injury embryo transfer. In this not-blinded, phase 2 clinical trial with control group, randomization was performed using random number table.
Women who were candidate for FET were randomly divided into two groups of either endometrial injury before embryo transfer or no endometrial injury embryo transfer. In this not-blinded, phase 2 clinical trial with control group, randomization was performed using random number table.
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بیماران کاندید انتقال جنین فریز به صورت تصادفی به دو گروه خراش اندومتر قبل از انتقال جنین و یا بدون خراش اندومتر قبل از انتقال جنین منجمد تقسیم شدند. در این کارازمایی بالینی دارای گروه کنترل با گروه های موازی، بدون کورسازی و فاز 2 تصادفی سازی با استفاده از جدول اعداد تصادفی صورت گرفت.
بیماران کاندید انتقال جنین فریز به صورت تصادفی به دو گروه خراش اندومتر قبل از انتقال جنین و یا بدون خراش اندومتر قبل از انتقال جنین منجمد تقسیم شدند. در این کارازمایی بالینی دارای گروه کنترل با گروه های موازی، بدون کورسازی و فاز 2 تصادفی سازی با استفاده از جدول اعداد تصادفی صورت گرفت.
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100 women who were candidate for FET at Yazd Research and Clinical Center for Infertility were divided randomly without blindness into two groups of either endometrial injury before embryo transfer or no endometrial injury embryo transfer.
100 women who were candidate for FET at Yazd Research and Clinical Center for Infertility were divided randomly without blindness into two groups of either endometrial injury before embryo transfer or no endometrial injury embryo transfer.
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100 زن کاندید انتقال جنین فریز در مرکز تحقیقاتی و درمانی ناباروری یزد به صورت تصادفی و بدون کورسازی به دو گروه خراش اندومتر قبل از انتقال جنین و یا بدون خراش اندومتر قبل از انتقال جنین منجمد تقسیم شدند.
100 زن کاندید انتقال جنین فریز در مرکز تحقیقاتی و درمانی ناباروری یزد به صورت تصادفی و بدون کورسازی به دو گروه خراش اندومتر قبل از انتقال جنین و یا بدون خراش اندومتر قبل از انتقال جنین منجمد تقسیم شدند.
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The inclusion criteria include: women indicated for FET treatment, had one or more frozen embryo(s) and had a normal uterine cavity (confirmed by vaginal ultrasonography). The exclusion criteria were women <40 yrs, history of endocrine disorders (hypothyroidism, diabetes mellitus), intrauterine abnormality (uterine polyp, sub-mucosal fibroma, intrauterine adhesion) and severe endometriosis diagnosed by laparoscopy or endometrioma in ultrasound scanning.
The inclusion criteria include: women indicated for FET treatment, had one or more frozen embryo(s) and had a normal uterine cavity (confirmed by vaginal ultrasonography). The exclusion criteria were women <40 yrs, history of endocrine disorders (hypothyroidism, diabetes mellitus), intrauterine abnormality (uterine polyp, sub-mucosal fibroma, intrauterine adhesion) and severe endometriosis diagnosed by laparoscopy or endometrioma in ultrasound scanning.
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معیارهای ورود شامل زنان کاندید انتقال جنین فریز که یک عدد یا بیشتر جنین فریز جهت انتقال داشته باشند. حفره رحمی نرمال در سونوگرافی واژینال داشته باشند. معیارهای خروج: زنان بالای 40 سال، سابقه بیماریهای اندوکرین مثل هایپوتیروئیدی و دیابت، ناهنجاریهای داخل رحمی مثل پولیپ، فیبروم ساب موکوزال و چسبندگی داخل رحمی. اندومتریوز شدید تشخیص داده شده با لاپاروسکوپی و اندومتریوما تشخیص داده شده با سونوگرافی
معیارهای ورود شامل زنان کاندید انتقال جنین فریز که یک عدد یا بیشتر جنین فریز جهت انتقال داشته باشند. حفره رحمی نرمال در سونوگرافی واژینال داشته باشند. معیارهای خروج: زنان بالای 40 سال، سابقه بیماریهای اندوکرین مثل هایپوتیروئیدی و دیابت، ناهنجاریهای داخل رحمی مثل پولیپ، فیبروم ساب موکوزال و چسبندگی داخل رحمی. اندومتریوز شدید تشخیص داده شده با لاپاروسکوپی و اندومتریوما تشخیص داده شده با سونوگرافی
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Intervention group: endometrial injury before embryo transfer
Control group: No endometrial injury before embryo transfer
Intervention group: endometrial injury before embryo transfer Control group: No endometrial injury before embryo transfer
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گروه مداخله: خراش اندومتر پیش از انتقال جنین
گروه کنترل: بدون خراش اندومتر پیش از انتقال جنین
گروه مداخله: خراش اندومتر پیش از انتقال جنین گروه کنترل: بدون خراش اندومتر پیش از انتقال جنین
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Chemical pregnancy
Chemical pregnancy
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حاملگی شیمیایی
حاملگی شیمیایی
General information
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2015-03-21, 1394/01/01
2015-03-01, 1393/12/10
2015-03-2101 00:00:00
2015-09-23, 1394/07/01
2015-06-30, 1394/04/09
2015-0906-2330 00:00:00
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2015-03-01, 1393/12/10
2015-03-01 00:00:00
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2015-06-30, 1394/04/09
2015-06-30 00:00:00
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2015-12-29, 1394/10/08
2015-12-29 00:00:00
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Updating the trial according to the last changes in inclusion and exclusion criteria, actual number of cases, date of recruitment and trial completion
Updating the trial according to the last changes in inclusion and exclusion criteria, actual number of cases, date of recruitment and trial completion
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به روز رسانی کارازمایی بالینی بر اساس آخرین تغییرات در معیارهای ورود و خروج، تعداد بیماران، تاریخ نهایی بیمارگیری و پایان مطالعه
به روز رسانی کارازمایی بالینی بر اساس آخرین تغییرات در معیارهای ورود و خروج، تعداد بیماران، تاریخ نهایی بیمارگیری و پایان مطالعه
Infertile patients candidate for frozen- thawed embryo transfer who had one or more frozen embryo(s)
Women with a normal uterine cavity (confirmed by vaginal ultrasonography).
Infertile patients candidate for frozen- thawed embryo transfer who had one or more frozen embryo(s) Women with a normal uterine cavity (confirmed by vaginal ultrasonography).
بیماران نابارور کاندید انتقال جنین فریز که یک عدد یا بیشتر جنین فریز داشته باشد
زنان با حفره رحم نرمال اثبات شده در سونوگرافی واژینال
بیماران نابارور کاندید انتقال جنین فریز که یک عدد یا بیشتر جنین فریز داشته باشد زنان با حفره رحم نرمال اثبات شده در سونوگرافی واژینال
Women <40 yrs
History of endocrine disorders (hypothyroidism, diabetes mellitus)
Intrauterine abnormality (uterine polyp, sub-mucosal fibroma, intrauterine adhesion)
Severe endometriosis diagnosed by laparoscopy or endometrioma in ultrasound scanning.
Women <40 yrs History of endocrine disorders (hypothyroidism, diabetes mellitus) Intrauterine abnormality (uterine polyp, sub-mucosal fibroma, intrauterine adhesion) Severe endometriosis diagnosed by laparoscopy or endometrioma in ultrasound scanning.
زنان زیر 40 سال
سابقه بیماریهای اندوکرین مثل هایپو تیروئیدی و دیابت
اختلالات داخل رحمی مثل پولیپ رحمی، فیبروم ساب موکوزال، چسبندگی داخل رحمی
اندومتریوز شدید تشخیص داده شده با لاپاروسکوپی یا اندومتریوما در تشخیص سونوگرافی
زنان زیر 40 سال سابقه بیماریهای اندوکرین مثل هایپو تیروئیدی و دیابت اختلالات داخل رحمی مثل پولیپ رحمی، فیبروم ساب موکوزال، چسبندگی داخل رحمی اندومتریوز شدید تشخیص داده شده با لاپاروسکوپی یا اندومتریوما در تشخیص سونوگرافی
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In this trial, 100 infertile women who were candidate for frozen embryo transfer 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.
In this trial, 100 infertile women who were candidate for frozen embryo transfer 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.
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در این مطالعه 100 زن کاندید انتقال جنین فریز 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.
در این مطالعه 100 زن کاندید انتقال جنین فریز 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.
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Secondary outcomes
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clinical pregnancy
Clinical pregnancy
clinicalClinical pregnancy
2 weeks after positive B-HCG
3 weeks after positive B-HCG
23 weeks after positive B-HCG
2 هفته پس از مثبت شدن تست حاملگی
3 هفته پس از مثبت شدن تست حاملگی
23 هفته پس از مثبت شدن تست حاملگی
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: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr.Abass Aflatounian, Professor of Shahid Sadoughi University of medical sciences
Full name of responsible person - Persian: دکتر عباس افلاطونیان، فلوشیپ ناباروری، استاد دانشگاه علوم پزشکی شهید صدوقی یزد
Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
Street address - Persian: یزد،صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری یزد
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: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr.Abass Aflatounian, Professor of Shahid Sadoughi University of medical sciences
Full name of responsible person - Persian: دکتر عباس افلاطونیان، فلوشیپ ناباروری، استاد دانشگاه علوم پزشکی شهید صدوقی یزد
Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
Street address - Persian: یزد،صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری یزد
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Fax:
Email: abbas_aflatooian@yahoo.com
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: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد Full name of responsible person - English: Dr.Abass Aflatounian, Professor of Shahid Sadoughi University of medical sciences Full name of responsible person - Persian: دکتر عباس افلاطونیان، فلوشیپ ناباروری، استاد دانشگاه علوم پزشکی شهید صدوقی یزد Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility Street address - Persian: یزد،صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری یزد City - English: yazdYazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Fax: Email: abbas_aflatooian@yahoo.com Web page address:
Sponsors / Funding sources
#1
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: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr.Abass Aflatounian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی ناباروری
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 University of Medical Sciences Name of organization / entity - Persian: مركز تحقيقاتيمعاونت تحقیقات و درماني ناباروري،فناوری دانشگاه علوم پزشکی شهید صدوقی یزد Full name of responsible person - English: Dr.Abass AflatounianMasoud Mirzaei Full name of responsible person - Persian: دکتر عباس افلاطونیانمسعود میرزایی Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for InfertilityBahonar Square Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی ناباروریمیدان باهنر City - English: yazdYazd 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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Domestic
domestic
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Academic
academic
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Deputy of Research and technology, Yazd Shahid Sadoughi Medical Sciences
Deputy of Research and Clinical Center for Infertilitytechnology, Yazd Shahid Sadoughi University of Medical Sciences
مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید صدوقی یزد
مركز تحقيقاتيمعاونت تحقیقات و درماني ناباروري،فناوری 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, Shahid Sadoughi University of Medical Sciences
Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr.Abass Aflatounian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Position - English: Professor
Position - Persian: استاد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی 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 3824 7085
Mobile: +98 913 151 5349
Fax: +98 35 3824 7087
Email: abbas_aflatoonian@yahoo.com
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: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr.Abass Aflatounian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Position - English: Professor
Position - Persian: استاد
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی 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 3824 7085
Mobile: +98 913 151 5349
Fax: +98 35 3824 7087
Email: abbas_aflatoonian@yahoo.com
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: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد Full name of responsible person - English: Dr.Abass Aflatounian Full name of responsible person - Persian: دکتر عباس افلاطونیان Position - English: Professor Position - Persian: استاد Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی ناباروری City - English: yazdYazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Mobile: +98 913 151 5349 Fax: +98 35 3824 7087 Email: abbas_aflatoonian@yahoo.com 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: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr.Abass Aflatounian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Position - English: Professor
Position - Persian: استاد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی 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 3824 7085
Mobile: +98 913 151 5349
Fax: +98 35 3824 7087
Email: abbas_aflatoonian@yahoo.com
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: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr.Abass Aflatounian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Position - English: Professor
Position - Persian: استاد
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی 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 3824 7085
Mobile: +98 913 151 5349
Fax: +98 35 3824 7087
Email: abbas_aflatoonian@yahoo.com
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: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی یزد Full name of responsible person - English: Dr.Abass Aflatounian Full name of responsible person - Persian: دکتر عباس افلاطونیان Position - English: Professor Position - Persian: استاد Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی ناباروری City - English: yazdYazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Mobile: +98 913 151 5349 Fax: +98 35 3824 7087 Email: abbas_aflatoonian@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Sadoughi University of Medical Sciences ,Yazd
Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی
Full name of responsible person - English: Dr.Abass Aflatounian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Position - English: Professor
Position - Persian: استاد
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 , Research and Clinical Center for Infertility
Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی 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 3824 7085
Mobile: +98 913 151 5349
Fax: +98 35 3824 7087
Email: abbas_aflatoonian@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Sadoughi University of Medical Sciences ,Yazd
Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی
Full name of responsible person - English: Dr.Abass Aflatounian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Position - English: Professor
Position - Persian: استاد
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 , Research and Clinical Center for Infertility
Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی 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 3824 7085
Mobile: +98 913 151 5349
Fax: +98 35 3824 7087
Email: abbas_aflatoonian@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Sadoughi University of Medical Sciences ,Yazd Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري، دانشگاه علوم پزشکی شهید صدوقی Full name of responsible person - English: Dr.Abass Aflatounian Full name of responsible person - Persian: دکتر عباس افلاطونیان Position - English: Professor Position - Persian: استاد 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 , Research and Clinical Center for Infertility Street address - Persian: صفائيه، خ بوعلي، مرکزتحقیقاتی و درمانی ناباروری City - English: yazdYazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Mobile: +98 913 151 5349 Fax: +98 35 3824 7087 Email: abbas_aflatoonian@yahoo.com Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
empty
All participant data sets are to be shared
All participant data sets are to be shared
empty
کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
empty
2 months after the result publication
2 months after the result publication
empty
2 ماه بعد از چاپ نتایج
2 ماه بعد از چاپ نتایج
empty
A journal in which the results are published
A journal in which the results are published
empty
ژورنال چاپ کننده نتایج
ژورنال چاپ کننده نتایج
empty
Submission of an official application via the agent that is legally in charge
Submission of an official application via the agent that is legally in charge
empty
درخواست رسمی از طریق مرجع قانونی
درخواست رسمی از طریق مرجع قانونی
empty
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran.
983538247085
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085
empty
پژوهشکده علوم تولید مثل یزد، خیابان بوعلی، یزد، ایران.
پژوهشکده علوم تولید مثل یزد، خیابان بوعلی، یزد، ایران.
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
Whether endometrial injury in luteal phase prior to FET cycle would improve pregnancy outcomes
Design
Women who were candidate for FET were randomly divided into two groups of either endometrial injury before embryo transfer or no endometrial injury embryo transfer. In this not-blinded, phase 2 clinical trial with control group, randomization was performed using random number table.
Settings and conduct
100 women who were candidate for FET at Yazd Research and Clinical Center for Infertility were divided randomly without blindness into two groups of either endometrial injury before embryo transfer or no endometrial injury embryo transfer.
Participants/Inclusion and exclusion criteria
The inclusion criteria include: women indicated for FET treatment, had one or more frozen embryo(s) and had a normal uterine cavity (confirmed by vaginal ultrasonography). The exclusion criteria were women <40 yrs, history of endocrine disorders (hypothyroidism, diabetes mellitus), intrauterine abnormality (uterine polyp, sub-mucosal fibroma, intrauterine adhesion) and severe endometriosis diagnosed by laparoscopy or endometrioma in ultrasound scanning.
Intervention groups
Intervention group: endometrial injury before embryo transfer
Control group: No endometrial injury before embryo transfer
Main outcome variables
Chemical pregnancy
General information
Reason for update
Updating the trial according to the last changes in inclusion and exclusion criteria, actual number of cases, date of recruitment and trial completion
Acronym
IRCT registration information
IRCT registration number:IRCT2015101324512N1
Registration date:2015-11-13, 1394/08/22
Registration timing:retrospective
Last update:2021-04-12, 1400/01/23
Update count:2
Registration date
2015-11-13, 1394/08/22
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 and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2015-06-30, 1394/04/09
Actual recruitment start date
2015-03-01, 1393/12/10
Actual recruitment end date
2015-06-30, 1394/04/09
Trial completion date
2015-12-29, 1394/10/08
Scientific title
The effect of endometrial injury on pregnancy rate in frozen- thawed embryo transfer
Public title
The effect of endometrial injury on pregnancy rate in frozen- thawed embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile patients candidate for frozen- thawed embryo transfer who had one or more frozen embryo(s)
Women with a normal uterine cavity (confirmed by vaginal ultrasonography).
Exclusion criteria:
Women <40 yrs
History of endocrine disorders (hypothyroidism, diabetes mellitus)
Intrauterine abnormality (uterine polyp, sub-mucosal fibroma, intrauterine adhesion)
Severe endometriosis diagnosed by laparoscopy or endometrioma in ultrasound scanning.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this trial, 100 infertile women who were candidate for frozen embryo transfer 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
Shahid Sadoughi University of Medical Sciences
Street address
Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
City
yazd
Province
Yazd
Postal code
8916877391
Approval date
2015-02-10, 1393/11/21
Ethics committee reference number
445
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Chemicall pregnancy
Timepoint
14 days after transfer
Method of measurement
B-HCG test
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
3 weeks after positive B-HCG
Method of measurement
vaginal ultrasonography
Intervention groups
1
Description
In intervention group (50 patients)in cycle 21-23 days (before embryo transfer cycle) ,the edometrium is scratched with piple .
Category
Treatment - Drugs
2
Description
No intervention in control group is done.
Category
Treatment - Drugs
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
Dr.Abass Aflatounian, Professor of Shahid Sadoughi University of medical sciences
Street address
Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas_aflatooian@yahoo.com
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, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Abass Aflatounian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas_aflatoonian@yahoo.com
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
Dr.Abass Aflatounian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas_aflatoonian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sadoughi University of Medical Sciences ,Yazd
Full name of responsible person
Dr.Abass Aflatounian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safayeh , Research and Clinical Center for Infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas_aflatoonian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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
What processes are involved for a request to access data/document
Submission of an official application via the agent that is legally in charge