Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
The purpose of this study is to compare the clinical pregnancy rate of Natural and modified –natural cycle in frozen embryo transfer. This study is clinical trial, randomization, single center and double blind. Among Women will admitted to fertility unit of Arash hospital for planning an FET cycle, 140 will participated in this study. Age <38 years and regular ovulatory cycles are inclusion criteria. Exclusion criteria are PCOD and endometriosis. patients are divided two equal number.Group1: 70 patients with progestron pessary administration after positive urinary LH kit. Group 2: 70 patients with 5000 IU HCG injection IM state, after presenting endometrial thickness>7 mm and 17 mm dominant folicule in transvaginal sonography. After two weeks of FET procedure measurement of serum B-HCG will be carried out.
If the result of lab test was positive ?(B-HCG>10)clinical pregnancy, implantation, abortion rate will be evaluated.
empty
The purpose of this study is to compare the clinical pregnancy rate of Natural and modified –natural cycle in frozen embryo transfer. This study is clinical trial, randomization, single center and double blind. Among Women will admitted to fertility unit of Arash hospital for planning an FET cycle, 140 will participated in this study. Age <38 years and regular ovulatory cycles are inclusion criteria. Exclusion criteria are PCOD and endometriosis. patients are divided two equal number.Group1: 70 patients with progestron pessary administration after positive urinary LH kit. Group 2: 70 patients with 5000 IU HCG injection IM state, after presenting endometrial thickness>7 mm and 17 mm dominant folicule in transvaginal sonography. After two weeks of FET procedure measurement of serum B-HCG will be carried out. If the result of lab test was positive ?(B-HCG>10)clinical pregnancy, implantation, abortion rate will be evaluated.
هدف مطالعه مقایسه میزان بارداری کلینیکی در 2 گروه مورد مطالعه Natural و Modified Naturalمی باشد.
این مطالعه به صورت کارازمایی بالینی ،تصادفي، دوسويه كور ، تك مركزي میباشد.
جمعيت مورد مطالعه: بیماران مراجعه کننده با شکایت نازایی که کاندید انتقال فریز شده جنین هستند و به واحد نازایی بیمارستان جامع بانوان آرش مراجعه می کنند.معیارهای ورود شامل: سن حداکثر 38 سال، . سیکل های قاعدگی منظم ومعیارهای خروج :
ابتلا به PCO و اندومتریوز میباشد. حجم نمونه 140 نفر میباشد که 70 نفر در هر گروه قرار خواهند گرفت. به گروه اول بعد از مثبت شدن کیت ادراریLH شیاف پروژسترون داده میشود.به گروه دوم بعد از مشاهده ی فولیکول غالب mm17 و ضخامت آندومتر mm7≤ ،HCG 5000 واحد IUیک بار به بیمار تزریق می شود.سپس جنین فریز شده منتقل میشود. و در روز 14 بعد از انتقال سطح سرمی BHCG اندازه گیری میشود. در صورت بارداری میزان لانه گزینی، بارداری کلینیکی و میزان سقط بررسی میشود.
empty
هدف مطالعه مقایسه میزان بارداری کلینیکی در 2 گروه مورد مطالعه Natural و Modified Naturalمی باشد. این مطالعه به صورت کارازمایی بالینی ،تصادفي، دوسويه كور ، تك مركزي میباشد. جمعيت مورد مطالعه: بیماران مراجعه کننده با شکایت نازایی که کاندید انتقال فریز شده جنین هستند و به واحد نازایی بیمارستان جامع بانوان آرش مراجعه می کنند.معیارهای ورود شامل: سن حداکثر 38 سال، . سیکل های قاعدگی منظم ومعیارهای خروج : ابتلا به PCO و اندومتریوز میباشد. حجم نمونه 140 نفر میباشد که 70 نفر در هر گروه قرار خواهند گرفت. به گروه اول بعد از مثبت شدن کیت ادراریLH شیاف پروژسترون داده میشود.به گروه دوم بعد از مشاهده ی فولیکول غالب mm17 و ضخامت آندومتر mm7≤ ،HCG 5000 واحد IUیک بار به بیمار تزریق می شود.سپس جنین فریز شده منتقل میشود. و در روز 14 بعد از انتقال سطح سرمی BHCG اندازه گیری میشود. در صورت بارداری میزان لانه گزینی، بارداری کلینیکی و میزان سقط بررسی میشود.
empty
Comparing the rate of pregnancy of Natural versus modified –natural cycle in frozen embryo transfer
Comparing the rate of pregnancy of Natural versus modified –natural cycle in frozen embryo transfer
empty
مقایسه دو روش طبیعی و تعدیل یافته در اماده سازی اندومتر در انتقال جنینی فریز شده بر میزان حامله شدن
مقایسه دو روش طبیعی و تعدیل یافته در اماده سازی اندومتر در انتقال جنینی فریز شده بر میزان حامله شدن
empty
Single blinded randomized controlled clinical trial
Single blinded randomized controlled clinical trial
empty
کارآزمایی بالینی کنترل شده تصادفی یک سوکور
کارآزمایی بالینی کنترل شده تصادفی یک سوکور
empty
Settings: Arash Women's Hospital
Blinding: Single-blind (outcome assessor and data analyst)
Settings: Arash Women's Hospital Blinding: Single-blind (outcome assessor and data analyst)
empty
محل انجام: بیمارستان جامع یانوان آرش
کورسازی: یک سو کور (افراد ارزیابی کننده پیامد و فرد آنالیز کننده داده ها)
محل انجام: بیمارستان جامع یانوان آرش کورسازی: یک سو کور (افراد ارزیابی کننده پیامد و فرد آنالیز کننده داده ها)
empty
Inclusion criteria: maximum age 38 years, regular menstrual cycles
Exclusion criteria: PCO, endometriosis, FSH ≥ 12 IVF and Severe Male Factor
Inclusion criteria: maximum age 38 years, regular menstrual cycles Exclusion criteria: PCO, endometriosis, FSH ≥ 12 IVF and Severe Male Factor
empty
* معیارهای ورود: سن حداکثر 38 سال، سیکل های قاعدگی منظم
* معیارهای خروج : ابتلا به PCO، اندومتریوز، FSH ≥ 12 IVF و Severe Male Factor
* معیارهای ورود: سن حداکثر 38 سال، سیکل های قاعدگی منظم * معیارهای خروج : ابتلا به PCO، اندومتریوز، FSH ≥ 12 IVF و Severe Male Factor
empty
Group1: will receive vaginal progesterone after positive urinary LH kit. Group 2: 5000 IU HCG injection IM state, after presenting endometrial thickness>7 mm and 17 mm dominant folicule in transvaginal sonography.
Group1: will receive vaginal progesterone after positive urinary LH kit. Group 2: 5000 IU HCG injection IM state, after presenting endometrial thickness>7 mm and 17 mm dominant folicule in transvaginal sonography.
empty
به گروه اول بعد از مثبت شدن کیت ادراریLH شیاف پروژسترون داده میشود.به گروه دوم بعد از مشاهده ی فولیکول غالب mm17 و ضخامت آندومتر mm7≤ ،HCG 5000 واحد IUیک بار به بیمار تزریق می شود.
به گروه اول بعد از مثبت شدن کیت ادراریLH شیاف پروژسترون داده میشود.به گروه دوم بعد از مشاهده ی فولیکول غالب mm17 و ضخامت آندومتر mm7≤ ،HCG 5000 واحد IUیک بار به بیمار تزریق می شود.
Age below 38
Regular menstrual cycle
Normal BMI
The previous history of up to two IVF cycle
Age below 38 Regular menstrual cycle Normal BMI The previous history of up to two IVF cycle
سن حداکثر 38 سال
سیکل های قاعدگی منظم ( 35-25 روز )
BMI نرمال (19-24.9)
سابقه حداکثر2 بار IVF قبلی
سن حداکثر 38 سال سیکل های قاعدگی منظم ( 35-25 روز ) BMI نرمال (19-24.9) سابقه حداکثر2 بار IVF قبلی
PCOD
History of endometriosis ( grade ≥3) according to AFS
Abnormal uterin
FSH ≥12
Sever male factor
PCOD History of endometriosis ( grade ≥3) according to AFS Abnormal uterin FSH ≥12 Sever male factor
سابقه PCOD
سابقه آندومتریوز با درجه ≥ 3 طبق AFS
ناهنجاری های رحمی
FSH ≥ 12
IVF به دلیل Severe Male Factor
سابقه PCOD سابقه آندومتریوز با درجه ≥ 3 طبق AFS ناهنجاری های رحمی FSH ≥ 12 IVF به دلیل Severe Male Factor
empty
The patients underwent FET according to a computer-generated concealed randomization list using the block randomization method. There were six blocks. The statistician prepared random treatment assignments in sealed envelopes to conceal the randomization list from all research staff involved in enrollment and assessment.
The patients underwent FET according to a computer-generated concealed randomization list using the block randomization method. There were six blocks. The statistician prepared random treatment assignments in sealed envelopes to conceal the randomization list from all research staff involved in enrollment and assessment.
empty
بیماران بر اساس لیست تصادفی سازی پنهان تولید شده توسط کامپیوتر با استفاده از روش تصادفی سازی بلوکی تحت FET قرار گرفتند. سایز بلوک ها شش در نظر گرفته شد. متخصص آمار، گروه های درمانی تصادفی را در پاکتهای مهر و موم شده قرار داد تا فهرست تصادفیسازی را از همه افراد تیم پژوهشی درگیر در ثبتنام و ارزیابی پنهان کند.
بیماران بر اساس لیست تصادفی سازی پنهان تولید شده توسط کامپیوتر با استفاده از روش تصادفی سازی بلوکی تحت FET قرار گرفتند. سایز بلوک ها شش در نظر گرفته شد. متخصص آمار، گروه های درمانی تصادفی را در پاکتهای مهر و موم شده قرار داد تا فهرست تصادفیسازی را از همه افراد تیم پژوهشی درگیر در ثبتنام و ارزیابی پنهان کند.
empty
This study was designed as a single blinded study and the outcome investigators (infertility clinic’s midwife and the gynecologist who performed ultrasound assessments), and the statistician were unaware of the type of intervention until the end of the study.
This study was designed as a single blinded study and the outcome investigators (infertility clinic’s midwife and the gynecologist who performed ultrasound assessments), and the statistician were unaware of the type of intervention until the end of the study.
empty
این مطالعه به صورت یک مطالعه یک سوکور طراحی شد و محققین بررسی کننده پیامد نهایی مطالعه (مامای کلینیک ناباروری و متخصص زنان که ارزیابی سونوگرافی را انجام دادند) و آمارگیر تا پایان مطالعه از نوع مداخله بی اطلاع بودند.
این مطالعه به صورت یک مطالعه یک سوکور طراحی شد و محققین بررسی کننده پیامد نهایی مطالعه (مامای کلینیک ناباروری و متخصص زنان که ارزیابی سونوگرافی را انجام دادند) و آمارگیر تا پایان مطالعه از نوع مداخله بی اطلاع بودند.
empty
empty
Primary outcomes
#1
empty
Chemical Pregnancy Rate
Chemical Pregnancy Rate
empty
میزان بارداری شیمیایی
میزان بارداری شیمیایی
empty
2 weeks after embryo transfer
2 weeks after embryo transfer
empty
دو هفته پس از انتقال جنین
دو هفته پس از انتقال جنین
empty
Blood Pregnancy Test (BHCG)
Blood Pregnancy Test (BHCG)
empty
تست خون بارداری (BHCG)
تست خون بارداری (BHCG)
Secondary outcomes
#1
empty
Ongoing Pregnancy Rate
Ongoing Pregnancy Rate
empty
میزان بارداری ادامه یافته
میزان بارداری ادامه یافته
empty
12 weeks of gestation
12 weeks of gestation
empty
هفته 12 بارداری
هفته 12 بارداری
empty
The rate of pregnancies that continued ≥12 weeks of gestation.
The rate of pregnancies that continued ≥12 weeks of gestation.
empty
میزان بارداری هایی که بیش از 12 هفته ادامه یافته باشند
میزان بارداری هایی که بیش از 12 هفته ادامه یافته باشند
#2
empty
Endometrial thickness
Endometrial thickness
empty
ضخامت اندومتر
ضخامت اندومتر
empty
At regular intervals until the endometrial thickness reaches above 7 mm
At regular intervals until the endometrial thickness reaches above 7 mm
empty
در فواصل منظم تا هر زمانی که ضخامت اندومتر به بالای 7 میلی متر برسد
در فواصل منظم تا هر زمانی که ضخامت اندومتر به بالای 7 میلی متر برسد
empty
Transvaginal Ultrasound
Transvaginal Ultrasound
empty
سونوگرافی ترانس واژینال
سونوگرافی ترانس واژینال
#3
empty
No. of embryos transferred
No. of embryos transferred
empty
تعداد جنین های انتقال یافته
تعداد جنین های انتقال یافته
empty
At the time of embryo transfer
At the time of embryo transfer
empty
در زمان انتقال جنین
در زمان انتقال جنین
empty
Embryologist's report
Embryologist's report
empty
گزارش جنین شناس
گزارش جنین شناس
Recruitment centers
#1
Name of recruitment center - English: Arash women's hospital
Name of recruitment center - Persian: بیمارستان جامع بانوان آرش
Full name of responsible person - English: Ladan Kashani
Full name of responsible person - Persian: دکتر لادن کاشانی
Street address - English: Arash women's hospital, Reslat highway, Tehranpars, Rashid Ave.
Street address - Persian:
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Arash women's hospital
Name of recruitment center - Persian: بیمارستان جامع بانوان آرش
Full name of responsible person - English: Dr Ladan Kashani
Full name of responsible person - Persian: دکتر لادن کاشانی
Street address - English: Arash women's hospital, Reslat highway, Tehranpars, Rashid Ave.
Street address - Persian: تهران، بزرگراه رسالت، بعد از اتوبان شهید باقری، خیابان شهید باغدارنیا ( رشید شمالی)، خیابان 162 (عبدالمجید)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1653915981
Phone: +98 21 7788 3283
Fax:
Email: kashani_ladan@tums.ac.ir
Web page address:
Name of recruitment center - English: Arash women's hospital Name of recruitment center - Persian: بیمارستان جامع بانوان آرش Full name of responsible person - English: Dr Ladan Kashani Full name of responsible person - Persian: دکتر لادن کاشانی Street address - English: Arash women's hospital, Reslat highway, Tehranpars, Rashid Ave. Street address - Persian: تهران، بزرگراه رسالت، بعد از اتوبان شهید باقری، خیابان شهید باغدارنیا ( رشید شمالی)، خیابان 162 (عبدالمجید) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1653915981 Phone: +98 21 7788 3283 Fax: Email: kashani_ladan@tums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical scinces/Vice chancellor for research
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران، معاونت پژوهشی
Full name of responsible person - English: Dr Akbar Fotoohi
Full name of responsible person - Persian: دکتر اکبرفتوحی
Street address - English: Vice chansellor for research, Tehran University of Medical scinces
Street address - Persian: دانشگاه علوم پزشکی تهران، معاونت پژوهشی
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical scinces/Vice chancellor for research
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران، معاونت پژوهشی
Full name of responsible person - English: Dr Akbar Fotoohi
Full name of responsible person - Persian: دکتر اکبرفتوحی
Street address - English: Vice chansellor for research, Tehran University of Medical scinces
Street address - Persian: دانشگاه علوم پزشکی تهران، معاونت پژوهشی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 8838 8988
Fax:
Email: resdeputy@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical scinces/Vice chancellor for research Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران، معاونت پژوهشی Full name of responsible person - English: Dr Akbar Fotoohi Full name of responsible person - Persian: دکتر اکبرفتوحی Street address - English: Vice chansellor for research, Tehran University of Medical scinces Street address - Persian: دانشگاه علوم پزشکی تهران، معاونت پژوهشی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 8838 8988 Fax: Email: resdeputy@tums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Saedeh Aref
Full name of responsible person - Persian: سعیده عارف
Position - English: Resident
Position - Persian: رزیدنت
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arash women's hospital, Reslat highway, Tehranpars, Rashid Ave.
Street address - Persian: Arash women's hospital, Reslat highway, Tehranpars, Rashid Ave.
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 7771 9922
Mobile: +98 911 376 3591
Fax:
Email: soura036@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Saedeh Aref
Full name of responsible person - Persian: سعیده عارف
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arash women's hospital, Reslat highway, Tehranpars, Rashid Ave.
Street address - Persian: Arash women's hospital, Reslat highway, Tehranpars, Rashid Ave.
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1653915981
Phone: +98 21 7771 9922
Mobile: +98 911 376 3591
Fax:
Email: soura036@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران Full name of responsible person - English: Saedeh Aref Full name of responsible person - Persian: سعیده عارف Position - English: Resident Position - Persian: رزیدنت Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Arash women's hospital, Reslat highway, Tehranpars, Rashid Ave. Street address - Persian: Arash women's hospital, Reslat highway, Tehranpars, Rashid Ave. City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1653915981 Phone: +98 21 7771 9922 Mobile: +98 911 376 3591 Fax: Email: soura036@gmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Ladan Kashani
Full name of responsible person - Persian: لادن کاشانی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arash women's Hospital, Resalat highway, Tehranpars, Rashid Ave.
Street address - Persian: اتوبان رسالت، تهرانپارس، خ رشید، بیمارستان جامع بانوان آرش
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 7771 9922
Mobile: 00
Fax:
Email: kashani_ladan@razi.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Ladan Kashani
Full name of responsible person - Persian: لادن کاشانی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arash women's Hospital, Resalat highway, Tehranpars, Rashid Ave.
Street address - Persian: اتوبان رسالت، تهرانپارس، خ رشید، بیمارستان جامع بانوان آرش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1653915981
Phone: +98 21 7771 9922
Mobile: +98 912 204 7326
Fax:
Email: kashani_ladan@razi.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران Full name of responsible person - English: Ladan Kashani Full name of responsible person - Persian: لادن کاشانی Position - English: Assistant professor Position - Persian: استادیار Latest degree: sub_specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Arash women's Hospital, Resalat highway, Tehranpars, Rashid Ave. Street address - Persian: اتوبان رسالت، تهرانپارس، خ رشید، بیمارستان جامع بانوان آرش City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1653915981 Phone: +98 21 7771 9922 Mobile: 00+98 912 204 7326 Fax: Email: kashani_ladan@razi.tums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: saedeh Aref
Full name of responsible person - Persian: سعیده عارف
Position - English: Resident
Position - Persian: پزشک
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arash Women's Hospital, Resalt highway, Tehranpars, Rashid Ave.
Street address - Persian: ،تهرانپارس، اتوبان رسالت، خ شهید باغدار نیا،بیمارستان روئین تن آرش
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 7771 9922
Mobile: 00
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Maryam Farid Mojtahedi
Full name of responsible person - Persian: مریم فرید مجتهدی
Position - English: assistant professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English: infertility
Area of specialty/work title - Persian: نازایی
Street address - English: baghdarnia Ave.,Resalat Highway,Tehranpars
Street address - Persian: ،تهرانپارس، اتوبان رسالت، خ شهید باغدار نیا،بیمارستان روئین تن آرش
City - English: Tehran
City - Persian: Tehran
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1589857546
Phone: +98 912 123 0934
Mobile: +98 912 123 0934
Fax:
Email: m_fmojtahedi@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران Full name of responsible person - English: saedeh ArefMaryam Farid Mojtahedi Full name of responsible person - Persian: سعیده عارفمریم فرید مجتهدی Position - English: Residentassistant professor Position - Persian: پزشکاستادیار Latest degree: sub_specialist Area of specialty/work: 049 Area of specialty/work title - English: infertility Area of specialty/work title - Persian: نازایی Street address - English: Arash Women's Hospital, Resalt highway, Tehranpars, Rashid Ave.baghdarnia Ave.,Resalat Highway,Tehranpars Street address - Persian: ،تهرانپارس، اتوبان رسالت، خ شهید باغدار نیا،بیمارستان روئین تن آرش City - English: Tehran City - Persian: تهرانTehran Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1589857546 Phone: +98 21 7771 9922912 123 0934 Mobile: 00+98 912 123 0934 Fax: Email: m_fmojtahedi@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
The research team has not yet made a decision on this.
The research team has not yet made a decision on this.
empty
تیم پژوهشی هنوز تصمیمی در این مورد نگرفته است.
تیم پژوهشی هنوز تصمیمی در این مورد نگرفته است.
Protocol summary
Study aim
Comparing the rate of pregnancy of Natural versus modified –natural cycle in frozen embryo transfer
Design
Single blinded randomized controlled clinical trial
Settings and conduct
Settings: Arash Women's Hospital
Blinding: Single-blind (outcome assessor and data analyst)
Participants/Inclusion and exclusion criteria
Inclusion criteria: maximum age 38 years, regular menstrual cycles
Exclusion criteria: PCO, endometriosis, FSH ≥ 12 IVF and Severe Male Factor
Intervention groups
Group1: will receive vaginal progesterone after positive urinary LH kit. Group 2: 5000 IU HCG injection IM state, after presenting endometrial thickness>7 mm and 17 mm dominant folicule in transvaginal sonography.
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2016-08-22, 1395/06/01
Actual recruitment end date
2018-04-20, 1397/01/31
Trial completion date
2018-08-22, 1397/05/31
Scientific title
Comparing the rate of pregnancy of Natural versus modified –natural cycle for endometrial preparation in frozen embryo transfer
Public title
Comparing the rate of pregnancy of Natural versus modified –natural cycle in frozen embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age below 38
Regular menstrual cycle
Normal BMI
The previous history of up to two IVF cycle
Exclusion criteria:
PCOD
History of endometriosis ( grade ≥3) according to AFS
Abnormal uterin
FSH ≥12
Sever male factor
Age
To 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
140
Actual sample size reached:
110
Randomization (investigator's opinion)
Randomized
Randomization description
The patients underwent FET according to a computer-generated concealed randomization list using the block randomization method. There were six blocks. The statistician prepared random treatment assignments in sealed envelopes to conceal the randomization list from all research staff involved in enrollment and assessment.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study was designed as a single blinded study and the outcome investigators (infertility clinic’s midwife and the gynecologist who performed ultrasound assessments), and the statistician were unaware of the type of intervention until the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-08-09, 1395/05/19
Ethics committee reference number
IR.TUMS.MEDICINE.RBC.1395.426
Health conditions studied
1
Description of health condition studied
In vitro fertilization
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
6 weeks of pregnancy
Method of measurement
Ultrasonography
2
Description
Abortion rate
Timepoint
During 20 weeks of pregnancy
Method of measurement
Ulthrasonography, B-HCG
3
Description
Chemical Pregnancy Rate
Timepoint
2 weeks after embryo transfer
Method of measurement
Blood Pregnancy Test (BHCG)
Secondary outcomes
1
Description
Implantation
Timepoint
Gestational sac in 5 weeks of pregnancy
Method of measurement
ultrasonography
2
Description
Ongoing Pregnancy Rate
Timepoint
12 weeks of gestation
Method of measurement
The rate of pregnancies that continued ≥12 weeks of gestation.
3
Description
Endometrial thickness
Timepoint
At regular intervals until the endometrial thickness reaches above 7 mm
Method of measurement
Transvaginal Ultrasound
4
Description
No. of embryos transferred
Timepoint
At the time of embryo transfer
Method of measurement
Embryologist's report
Intervention groups
1
Description
The control group(1): progestron pessary administration after positive urinary LH kit
Category
Treatment - Drugs
2
Description
5000 Iu HCG injection IM state, after presenting endometrial thickness>7 mm and 17 mm dominant follicule in trans-vaginal ultrasonography