The effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination: a single blind randomized clinical trial
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Protocol summary
Objectives: To assess the effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination.
Design: A single blind randomized clinical trial.
Setting and conduct: The eligible patients undergoing intrauterine insemination who will refer to … Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 35 years; body mass index less than or equal to 30 and greater than or equal to 18; normal mensural period; normal fallopian tube.
Exclusion criteria: Hirsutism; autoimmune disease; endocrine disease; using cigarette of alcohol.
Intervention group: Endometrial scratch using Pipelle in the luteal phase and one week before intrauterine insemination.
Control group: Introducing cotton swab into the uterus without scratching in the luteal phase and one week before intrauterine insemination.
Primary outcome: Assessing pregnancy three months after intervention using sonography.
Randomization: Random assignment of the patients to the intervention and control groups using random number table.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
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Objectives: To assess the effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination. Design: A single blind randomized clinical trial. Setting and conduct: The eligible patients undergoing intrauterine insemination who will refer to … Hospital during the study period will be enrolled into the trial. Inclusion criteria: Age of 18 to 35 years; body mass index less than or equal to 30 and greater than or equal to 18; normal mensural period; normal fallopian tube. Exclusion criteria: Hirsutism; autoimmune disease; endocrine disease; using cigarette of alcohol. Intervention group: Endometrial scratch using Pipelle in the luteal phase and one week before intrauterine insemination. Control group: Introducing cotton swab into the uterus without scratching in the luteal phase and one week before intrauterine insemination. Primary outcome: Assessing pregnancy three months after intervention using sonography. Randomization: Random assignment of the patients to the intervention and control groups using random number table. Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
اهداف: تعيين اثر ایجاد خراش اندومتر نسبت به عدم ایجاد خراش بر پیامد حاملگی در بیماران کاندید تلقیح داخل رحمی.
طراحی: کارآزمایی بالینی تصادفی شده یک سو کور.
نحوه انجام: بیماران مبتلا کاندید تلقیح داخل رحمی که در طول مطالعه به بیمارستان فاطمیه مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد.
شرایط ورود: سن 18 تا 35 سال؛ شاخص توده بدنی کمتر یا مساوی 30 و بیشتر یا مساوی 18؛ سیکل قاعدگی نرمال؛ لوله فالوپ نرمال.
شرایط خروج: هیرسوتیسم؛ بیماری اتوایمون؛ بیماری اندوکرین؛ مصرف سیگار و الکل.
گروه مداخله: ایجاد خراش اندومتر به وسیله پایپل در فاز لوتئال و یک هفته قبل از تلقیح داخل رحمی.
گروه کنترل: وارد نمودن سواپ پنبه ای داخل رحم بدون ایجاد خراش در فاز لوتئال و یک هفته قبل از تلقیح داخل رحمی
پیامد اولیه: بررسی حاملگی سه ماه بعد از مداخله با استفاده از سونوگرافی.
روش تصادفی سازی: تخصیص تصادفی بیماران به گروههای مداخله و کنترل با استفاده از جدول اعداد تصادفی.
روش کورسازی: بیمار از نوع مداخله اطلاعی نخواهد داشت. لذا مطالعه به صورت یک سو کور اجرا خواهد شد.
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اهداف: تعيين اثر ایجاد خراش اندومتر نسبت به عدم ایجاد خراش بر پیامد حاملگی در بیماران کاندید تلقیح داخل رحمی. طراحی: کارآزمایی بالینی تصادفی شده یک سو کور. نحوه انجام: بیماران مبتلا کاندید تلقیح داخل رحمی که در طول مطالعه به بیمارستان فاطمیه مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد. شرایط ورود: سن 18 تا 35 سال؛ شاخص توده بدنی کمتر یا مساوی 30 و بیشتر یا مساوی 18؛ سیکل قاعدگی نرمال؛ لوله فالوپ نرمال. شرایط خروج: هیرسوتیسم؛ بیماری اتوایمون؛ بیماری اندوکرین؛ مصرف سیگار و الکل. گروه مداخله: ایجاد خراش اندومتر به وسیله پایپل در فاز لوتئال و یک هفته قبل از تلقیح داخل رحمی. گروه کنترل: وارد نمودن سواپ پنبه ای داخل رحم بدون ایجاد خراش در فاز لوتئال و یک هفته قبل از تلقیح داخل رحمی پیامد اولیه: بررسی حاملگی سه ماه بعد از مداخله با استفاده از سونوگرافی. روش تصادفی سازی: تخصیص تصادفی بیماران به گروههای مداخله و کنترل با استفاده از جدول اعداد تصادفی. روش کورسازی: بیمار از نوع مداخله اطلاعی نخواهد داشت. لذا مطالعه به صورت یک سو کور اجرا خواهد شد.
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To assess the effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination.
To assess the effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination.
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تعيين اثر ایجاد خراش اندومتر نسبت به عدم ایجاد خراش بر پیامد حاملگی در بیماران کاندید تلقیح داخل رحمی
تعيين اثر ایجاد خراش اندومتر نسبت به عدم ایجاد خراش بر پیامد حاملگی در بیماران کاندید تلقیح داخل رحمی
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This is a single-blind randomized clinical trial, phase II, in which 300 eligible infertile women will be randomly assigned to the intervention and control groups
This is a single-blind randomized clinical trial, phase II, in which 300 eligible infertile women will be randomly assigned to the intervention and control groups
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این مطالعه کارآزمایی بالینی صادفی شده یک سو کور فاز 2 می باشد که در آن 300 زن نازای واجد شرایط به صورت تصادفي به دو گروه مداخله و کنترل تخصیص داده خواهند شد
این مطالعه کارآزمایی بالینی صادفی شده یک سو کور فاز 2 می باشد که در آن 300 زن نازای واجد شرایط به صورت تصادفي به دو گروه مداخله و کنترل تخصیص داده خواهند شد
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The eligible patients undergoing intrauterine insemination who will refer to … Hospital during the study period will be enrolled into the trial.
The eligible patients undergoing intrauterine insemination who will refer to … Hospital during the study period will be enrolled into the trial.
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بیماران مبتلا کاندید تلقیح داخل رحمی که در طول مطالعه به بیمارستان فاطمیه مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد
بیماران مبتلا کاندید تلقیح داخل رحمی که در طول مطالعه به بیمارستان فاطمیه مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد
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Inclusion criteria
Age of 18 to 40 years
Infertility
Body mass index less than or equal to 30 and greater than or equal to 18
Normal mensural period
Normal fallopian tube
Exclusion criteria
Hirsutism
Autoimmune disease
Endocrine disease
Using cigarette of alcohol
Inclusion criteria Age of 18 to 40 years Infertility Body mass index less than or equal to 30 and greater than or equal to 18 Normal mensural period Normal fallopian tube Exclusion criteria Hirsutism Autoimmune disease Endocrine disease Using cigarette of alcohol
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شرایط ورود
سن 18 تا 40 سال
شاخص توده بدنی کمتر یا مساوی 30 و بیشتر یا مساوی 18
سیکل قاعدگی نرمال
لوله فالوپ نرمال
شرایط خروج
هیرسوتیسم
بیماری اتوایمون
بیماری اندوکرین
مصرف سیگار و الکل
شرایط ورود سن 18 تا 40 سال شاخص توده بدنی کمتر یا مساوی 30 و بیشتر یا مساوی 18 سیکل قاعدگی نرمال لوله فالوپ نرمال شرایط خروج هیرسوتیسم بیماری اتوایمون بیماری اندوکرین مصرف سیگار و الکل
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Intervention group: Endometrial scratch using Pipelle in the luteal phase and one week before intrauterine insemination
Control group: Introducing cotton swab into the uterus without scratching in the luteal phase and one week before intrauterine insemination
Intervention group: Endometrial scratch using Pipelle in the luteal phase and one week before intrauterine insemination Control group: Introducing cotton swab into the uterus without scratching in the luteal phase and one week before intrauterine insemination
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گروه مداخله: ایجاد خراش اندومتر به وسیله پایپل در فاز لوتئال و یک هفته قبل از تلقیح داخل رحمی.
گروه کنترل: وارد نمودن سواپ پنبه ای داخل رحم بدون ایجاد خراش در فاز لوتئال و یک هفته قبل از تلقیح داخل رحمی
گروه مداخله: ایجاد خراش اندومتر به وسیله پایپل در فاز لوتئال و یک هفته قبل از تلقیح داخل رحمی. گروه کنترل: وارد نمودن سواپ پنبه ای داخل رحم بدون ایجاد خراش در فاز لوتئال و یک هفته قبل از تلقیح داخل رحمی
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Primary outcome: Assessing pregnancy three months after intervention using sonography.
Primary outcome: Assessing pregnancy three months after intervention using sonography.
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پیامد اولیه: بررسی حاملگی سه ماه بعد از مداخله با استفاده از سونوگرافی
پیامد اولیه: بررسی حاملگی سه ماه بعد از مداخله با استفاده از سونوگرافی
General information
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2017-09-23, 1396/07/01
2017-12-22, 1396/10/01
2017-0912-2322 00:00:00
2018-09-23, 1397/07/01
2018-12-22, 1397/10/01
2018-0912-2322 00:00:00
Age of 18 to 40years
Infertility
Body mass index less than or equal to 30 and greater than or equal to 18
Normal mensural period
Normal fallopian tube
Age of 18 to 40years Infertility Body mass index less than or equal to 30 and greater than or equal to 18 Normal mensural period Normal fallopian tube
سن 18 تا 40سال
نازایی
شاخص توده بدنی کمتر یا مساوی 30 و بیشتر یا مساوی 18
سیکل قاعدگی نرمال
لوله فالوپ نرمال
سن 18 تا 40سال نازایی شاخص توده بدنی کمتر یا مساوی 30 و بیشتر یا مساوی 18 سیکل قاعدگی نرمال لوله فالوپ نرمال
Hirsutism
Autoimmune disease
Endocrine disease
Using cigarette of alcohol
Hirsutism Autoimmune disease Endocrine disease Using cigarette of alcohol
هیرسوتیسم
بیماری اتوایمیون
بیماری اندوکرین
مصرف سیگار و الکل
هیرسوتیسم بیماری اتوایمیون بیماری اندوکرین مصرف سیگار و الکل
Randomization: Random assignment of the patients to the intervention and control groups using random number table.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
Randomization: Random assignment of the patients to the intervention and control groups using random number table. Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
روش تصادفی سازی: تخصیص تصادفی بیماران به گروههای مداخله و کنترل با استفاده از جدول اعداد تصادفی.
روش کورسازی: بیمار از نوع مداخله اطلاعی نخواهد داشت. لذا مطالعه به صورت یک سو کور اجرا خواهد شد.
روش تصادفی سازی: تخصیص تصادفی بیماران به گروههای مداخله و کنترل با استفاده از جدول اعداد تصادفی. روش کورسازی: بیمار از نوع مداخله اطلاعی نخواهد داشت. لذا مطالعه به صورت یک سو کور اجرا خواهد شد.
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Randomization: Random assignment of the patients to the intervention and control groups using random number table.
Randomization: Random assignment of the patients to the intervention and control groups using random number table.
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تخصیص تصادفی بیماران به گروههای مداخله و کنترل با استفاده از جدول اعداد تصادفی
تخصیص تصادفی بیماران به گروههای مداخله و کنترل با استفاده از جدول اعداد تصادفی
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Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
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بیمار از نوع مداخله اطلاعی نخواهد داشت. لذا مطالعه به صورت یک سو کور اجرا خواهد شد.
بیمار از نوع مداخله اطلاعی نخواهد داشت. لذا مطالعه به صورت یک سو کور اجرا خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: Fatemieh Hospital
Name of recruitment center - Persian: بیمارستان فاطمیه
Full name of responsible person - English: Dr Nesa Varmaghani
Full name of responsible person - Persian: دکتر نسا ورمقانی
Street address - English: Fatemieh Hospital, Pasdaran Ave.
Street address - Persian: خیابان پاسداران، بیمارستان فاطمیه
City - English: Hamadan
City - Persian: همدان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Fatemieh Hospital
Name of recruitment center - Persian: بیمارستان فاطمیه
Full name of responsible person - English: Dr Nesa Varmaghani
Full name of responsible person - Persian: دکتر نسا ورمقانی
Street address - English: Fatemieh Hospital, Pasdaran Ave.
Street address - Persian: خیابان پاسداران، بیمارستان فاطمیه
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3828 3939
Fax:
Email: nvarmaghani@gmail.com
Web page address:
Name of recruitment center - English: Fatemieh Hospital Name of recruitment center - Persian: بیمارستان فاطمیه Full name of responsible person - English: Dr Nesa Varmaghani Full name of responsible person - Persian: دکتر نسا ورمقانی Street address - English: Fatemieh Hospital, Pasdaran Ave. Street address - Persian: خیابان پاسداران، بیمارستان فاطمیه City - English: Hamadan City - Persian: همدان Province: Hamadan Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3828 3939 Fax: Email: nvarmaghani@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Name of organization / entity - Persian: معاونت تحقيقات و فناوري دانشگاه علوم پزشكي همدان
Full name of responsible person - English: Dr Saeid Bashirian
Full name of responsible person - Persian: دکتر سعید بشیریان
Street address - English: Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Street address - Persian: خيابان شهيد فهميده، دانشگاه علوم پزشكي همدان
City - English: Hamadan
City - Persian: همدان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Name of organization / entity - Persian: معاونت تحقيقات و فناوري دانشگاه علوم پزشكي همدان
Full name of responsible person - English: Dr Saeid Bashirian
Full name of responsible person - Persian: دکتر سعید بشیریان
Street address - English: Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Street address - Persian: خيابان شهيد فهميده، دانشگاه علوم پزشكي همدان
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3838 0717
Fax:
Email: info.research@umsha.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences Name of organization / entity - Persian: معاونت تحقيقات و فناوري دانشگاه علوم پزشكي همدان Full name of responsible person - English: Dr Saeid Bashirian Full name of responsible person - Persian: دکتر سعید بشیریان Street address - English: Hamadan University of Medical Sciences, Shahid Fahmideh Ave Street address - Persian: خيابان شهيد فهميده، دانشگاه علوم پزشكي همدان City - English: Hamadan City - Persian: همدان Province: Hamadan Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3838 0717 Fax: Email: info.research@umsha.ac.ir Web page address:
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Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Fatemieh Hospital
Name of organization / entity - Persian: بیمارستان فاطمیه
Full name of responsible person - English: Dr Nesa Varmaghani
Full name of responsible person - Persian: دکتر نسا ورمقانی
Position - English: Resident of Gynecology
Position - Persian: دستیار زنان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Fatemieh Hospital, Pasdaran Ave.
Street address - Persian: خیابان پاسداران، بیمارستان فاطمیه
City - English: Hamadan
City - Persian: همدان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 81 3828 3939
Mobile: +98 918 704 6711
Fax:
Email: nvarmaghani@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Fatemieh Hospital
Name of organization / entity - Persian: بیمارستان فاطمیه
Full name of responsible person - English: Dr Nesa Varmaghani
Full name of responsible person - Persian: دکتر نسا ورمقانی
Position - English: Resident of Gynecology
Position - Persian: دستیار زنان
Latest degree: med_doctor
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Fatemieh Hospital, Pasdaran Ave.
Street address - Persian: خیابان پاسداران، بیمارستان فاطمیه
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3828 3939
Mobile: +98 918 704 6711
Fax:
Email: nvarmaghani@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Fatemieh Hospital Name of organization / entity - Persian: بیمارستان فاطمیه Full name of responsible person - English: Dr Nesa Varmaghani Full name of responsible person - Persian: دکتر نسا ورمقانی Position - English: Resident of Gynecology Position - Persian: دستیار زنان Latest degree: med_doctor Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Fatemieh Hospital, Pasdaran Ave. Street address - Persian: خیابان پاسداران، بیمارستان فاطمیه City - English: Hamadan City - Persian: همدان Province: Hamadan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3828 3939 Mobile: +98 918 704 6711 Fax: Email: nvarmaghani@gmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Fatemieh Hospital
Name of organization / entity - Persian: بیمارستان فاطمیه
Full name of responsible person - English: Dr Nesa Varmaghani
Full name of responsible person - Persian: دکتر نسا ورمقانی
Position - English: Resident of Gynecology
Position - Persian: دستیار زنان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Fatemieh Hospital, Pasdaran Ave.
Street address - Persian: خیابان پاسداران، بیمارستان فاطمیه
City - English: Hamadan
City - Persian: همدان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 81 3828 3939
Mobile: +98 918 704 6711
Fax:
Email: nvarmaghani@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Fatemieh Hospital
Name of organization / entity - Persian: بیمارستان فاطمیه
Full name of responsible person - English: Dr Nesa Varmaghani
Full name of responsible person - Persian: دکتر نسا ورمقانی
Position - English: Resident of Gynecology
Position - Persian: دستیار زنان
Latest degree: med_doctor
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Fatemieh Hospital, Pasdaran Ave.
Street address - Persian: خیابان پاسداران، بیمارستان فاطمیه
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3828 3939
Mobile: +98 918 704 6711
Fax:
Email: nvarmaghani@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Fatemieh Hospital Name of organization / entity - Persian: بیمارستان فاطمیه Full name of responsible person - English: Dr Nesa Varmaghani Full name of responsible person - Persian: دکتر نسا ورمقانی Position - English: Resident of Gynecology Position - Persian: دستیار زنان Latest degree: med_doctor Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Fatemieh Hospital, Pasdaran Ave. Street address - Persian: خیابان پاسداران، بیمارستان فاطمیه City - English: Hamadan City - Persian: همدان Province: Hamadan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3828 3939 Mobile: +98 918 704 6711 Fax: Email: nvarmaghani@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Department of Epidemiology
Name of organization / entity - Persian: گروه اپيدميولوژي
Full name of responsible person - English: Dr Jalal Poorolajal
Full name of responsible person - Persian: دکتر جلال پورالعجل
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشكي همدان، دانشكده بهداشت
City - English: Hamadan
City - Persian: همدان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 81 3838 0090
Mobile: 00
Fax:
Email: poorolajal@umsha.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Epidemiology
Name of organization / entity - Persian: گروه اپيدميولوژي
Full name of responsible person - English: Dr Jalal Poorolajal
Full name of responsible person - Persian: دکتر جلال پورالعجل
Position - English: Professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشكي همدان، دانشكده بهداشت
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3838 0090
Mobile: +98 918 111 3963
Fax:
Email: poorolajal@umsha.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Epidemiology Name of organization / entity - Persian: گروه اپيدميولوژي Full name of responsible person - English: Dr Jalal Poorolajal Full name of responsible person - Persian: دکتر جلال پورالعجل Position - English: Associate Professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 02 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشكي همدان، دانشكده بهداشت City - English: Hamadan City - Persian: همدان Province: Hamadan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3838 0090 Mobile: 00+98 918 111 3963 Fax: Email: poorolajal@umsha.ac.ir Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
It depends on the situations and the results of study as well as approval of the financial supporting organization.
It depends on the situations and the results of study as well as approval of the financial supporting organization.
empty
به شرایط و نتایج مطالعه و موافقت سازمان حمایت کننده مالی بستگی دارد.
به شرایط و نتایج مطالعه و موافقت سازمان حمایت کننده مالی بستگی دارد.
Protocol summary
Study aim
To assess the effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination.
Design
This is a single-blind randomized clinical trial, phase II, in which 300 eligible infertile women will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients undergoing intrauterine insemination who will refer to … Hospital during the study period will be enrolled into the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age of 18 to 40 years
Infertility
Body mass index less than or equal to 30 and greater than or equal to 18
Normal mensural period
Normal fallopian tube
Exclusion criteria
Hirsutism
Autoimmune disease
Endocrine disease
Using cigarette of alcohol
Intervention groups
Intervention group: Endometrial scratch using Pipelle in the luteal phase and one week before intrauterine insemination
Control group: Introducing cotton swab into the uterus without scratching in the luteal phase and one week before intrauterine insemination
Main outcome variables
Primary outcome: Assessing pregnancy three months after intervention using sonography.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201707129014N174
Registration date:2017-07-14, 1396/04/23
Registration timing:prospective
Last update:2018-02-12, 1396/11/23
Update count:1
Registration date
2017-07-14, 1396/04/23
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination: a single blind randomized clinical trial
Public title
The effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40years
Infertility
Body mass index less than or equal to 30 and greater than or equal to 18
Normal mensural period
Normal fallopian tube
Exclusion criteria:
Hirsutism
Autoimmune disease
Endocrine disease
Using cigarette of alcohol
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Random assignment of the patients to the intervention and control groups using random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
IR.UMSHA.REC.1396.153
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Assessing pregnancy
Timepoint
three months after intervention
Method of measurement
using sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Endometrial scratch using Pipelle in the luteal phase and one week before intrauterine insemination.
Category
Treatment - Surgery
2
Description
Control group: Introducing cotton swab into the uterus without scratching in the luteal phase and one week before intrauterine insemination.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Nesa Varmaghani
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
nvarmaghani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Dr Nesa Varmaghani
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Fax
Email
nvarmaghani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Nesa Varmaghani
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Fax
Email
nvarmaghani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available