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Protocol summary
object: evaluation the effect of 17 alpha-hydroxyprogestrone caproate on decreasing miscarriage and preterm labour in women who are pregnant with ART Material and Method: We condoucted double blind placebo clinical trial on 106 pregnant women .
Inclusion criteria: succesful singletone pregnant women with ART teqnique at 16 weeks of gestation without history of previous preterm labour and without chronic disease and without cecellage and privious structural uterine anomalies(exclusion criteria)
Intervention: drug and placebo was injected intramuscularly from16-36weeks of gestation
Primary outcome: preterm labour and second trimestre abortion
Secondary outcome: neonatal outcome and drug complication
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object: evaluation the effect of 17 alpha-hydroxyprogestrone caproate on decreasing miscarriage and preterm labour in women who are pregnant with ART Material and Method: We condoucted double blind placebo clinical trial on 106 pregnant women . Inclusion criteria: succesful singletone pregnant women with ART teqnique at 16 weeks of gestation without history of previous preterm labour and without chronic disease and without cecellage and privious structural uterine anomalies(exclusion criteria) Intervention: drug and placebo was injected intramuscularly from16-36weeks of gestation Primary outcome: preterm labour and second trimestre abortion Secondary outcome: neonatal outcome and drug complication
هدف مطالعه: بررسی اثر 17-الفا هیدروکسی پروژسترون کاپروات در کاهش سقط وزایمان زودرس در زنانی که باروشهای کمک باروری باردار شده اند.
طراحی مطالعه: کارازمایی بالینی دوسو کور با دارو وپلاسبو میباشدکه برروی106 خانم باردارانجام میشود.
معیار ورود: زنانی که باروشهای کمک باروری حامله شده اند واکنون در16 هفتگی قرار دارندوحاملگی تک قلو دارند
معیار خروج: بیماری مزمن ندارند وسرکلاژنشده و سابقه زایمان زودرس ندارند ونیز ناهنجاریهای ساختمانی رحم ندارند.
مداخله وزمان مداخله: دارو وپلاسبوبصورت تزریقی وعضلانی از16-36 هفتگی تزریق میشود.
پیامد اولیه وبعدی: زایمان زودرس وسقط سه ماهه دوم وپیامد بعدی بررسی عوارض دارویی وپیامدهای نوزادی است
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هدف مطالعه: بررسی اثر 17-الفا هیدروکسی پروژسترون کاپروات در کاهش سقط وزایمان زودرس در زنانی که باروشهای کمک باروری باردار شده اند. طراحی مطالعه: کارازمایی بالینی دوسو کور با دارو وپلاسبو میباشدکه برروی106 خانم باردارانجام میشود. معیار ورود: زنانی که باروشهای کمک باروری حامله شده اند واکنون در16 هفتگی قرار دارندوحاملگی تک قلو دارند معیار خروج: بیماری مزمن ندارند وسرکلاژنشده و سابقه زایمان زودرس ندارند ونیز ناهنجاریهای ساختمانی رحم ندارند. مداخله وزمان مداخله: دارو وپلاسبوبصورت تزریقی وعضلانی از16-36 هفتگی تزریق میشود. پیامد اولیه وبعدی: زایمان زودرس وسقط سه ماهه دوم وپیامد بعدی بررسی عوارض دارویی وپیامدهای نوزادی است
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Evaluation of the effectiveness of 17 alpha-hydroxyprogestrone on decreasing abortion and preterm labor
Evaluation of the effectiveness of 17 alpha-hydroxyprogestrone on decreasing abortion and preterm labor
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بررسی اثر 17-الفا هیدروکسی پروژسترون در کاهش سقط و زایمان زودرس در زنانی که باروشهای کمک باروری باردار شده اند.
بررسی اثر 17-الفا هیدروکسی پروژسترون در کاهش سقط و زایمان زودرس در زنانی که باروشهای کمک باروری باردار شده اند.
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Women who met inclusion criteria, were informed about the trial design and signed a written consent form. Participants were consecutively enrolled the study and randomly divided into two groups using randomized list. Participants enrolled in a randomized parallel, double-blind, phase 2 clinical trial with control group. Randomization was performed using random number table
Women who met inclusion criteria, were informed about the trial design and signed a written consent form. Participants were consecutively enrolled the study and randomly divided into two groups using randomized list. Participants enrolled in a randomized parallel, double-blind, phase 2 clinical trial with control group. Randomization was performed using random number table
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زنان دارای شرایط ورود به مطالعه از نظر روش انجام طرح توجیه شدند و رضایت آگاهانه برای قرارگرفتن در هر یک از دو گروه مورد مطالعه به صورت تصادفی از آنها اخذ گردید. افراد به ترتیب مراجعه و با استفاده از لیست تصادفی سازی شده به دو گروه مورد نظر تخصیص یافتند. افراد در یک کارآزمایی بالینی دارای گروه کنترل با گروههای موازی، دوسویه کور فاز 2 و تصادفی سازی شده بوسیله یارانه با استفاده از جدول اعداد وارد شدند.
زنان دارای شرایط ورود به مطالعه از نظر روش انجام طرح توجیه شدند و رضایت آگاهانه برای قرارگرفتن در هر یک از دو گروه مورد مطالعه به صورت تصادفی از آنها اخذ گردید. افراد به ترتیب مراجعه و با استفاده از لیست تصادفی سازی شده به دو گروه مورد نظر تخصیص یافتند. افراد در یک کارآزمایی بالینی دارای گروه کنترل با گروههای موازی، دوسویه کور فاز 2 و تصادفی سازی شده بوسیله یارانه با استفاده از جدول اعداد وارد شدند.
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Women who got pregnant after ART at Yazd Infertility Center and were at 16th week of gestational age were randomly divided into two groups of 7-α hydroxy progesterone and placebo. A double blind trial was performed using placebo (similarity in amount, shape and administration method). patients and data analyzer were blinded to the trial
Women who got pregnant after ART at Yazd Infertility Center and were at 16th week of gestational age were randomly divided into two groups of 7-α hydroxy progesterone and placebo. A double blind trial was performed using placebo (similarity in amount, shape and administration method). patients and data analyzer were blinded to the trial
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زنانی که با کمک تکنیکهای کمک باروری در مرکز ناباروری یزد باردار شدند و در هفته 16 بارداری قرار داشتند با استفاده از جدول اعداد تصادفی به دو گروه استفاده از 17-الفا هیدروکسی پروژسترون و گروه پلاسبو تقسیم شدند. مطالعه به صورت دو سویه کور و استفاده از پلاسبو (مشابه در اندازه و شکل و نحوه تزریق) انجام شد. بیماران و همچنین آنالیز کننده آماری نسبت به تحقیق کور نگه داشته شده بودند.
زنانی که با کمک تکنیکهای کمک باروری در مرکز ناباروری یزد باردار شدند و در هفته 16 بارداری قرار داشتند با استفاده از جدول اعداد تصادفی به دو گروه استفاده از 17-الفا هیدروکسی پروژسترون و گروه پلاسبو تقسیم شدند. مطالعه به صورت دو سویه کور و استفاده از پلاسبو (مشابه در اندازه و شکل و نحوه تزریق) انجام شد. بیماران و همچنین آنالیز کننده آماری نسبت به تحقیق کور نگه داشته شده بودند.
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Inclusion criteria: Women who got pregnant after ART and were at 16 weeks of gestational age.
Exclusion criteria: Twin or multiple pregnancies; history of preterm labor; history of previous abortion; history of chronic diseases (Diabetes mellitus, Hypertention, and Hypo or Hyperthyroidism); uterine anatomical problems
Inclusion criteria: Women who got pregnant after ART and were at 16 weeks of gestational age. Exclusion criteria: Twin or multiple pregnancies; history of preterm labor; history of previous abortion; history of chronic diseases (Diabetes mellitus, Hypertention, and Hypo or Hyperthyroidism); uterine anatomical problems
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معیارهای ورود: زنانی که با کمک تکنیکهای کمک باروری باردار شدند و در هفته 16 بارداری قرار دارند.
معیارهای خروج: حاملگیهای دوقلو و چند قلو، سابقه زایمان زودرس، سابقه سقط، سابقه بیماریهای مزمن مانند دیابت، فشار خون، هیپوتیروئیدی یا هیپرتیروئیدی، مشکلات آناتومیکی رحم
معیارهای ورود: زنانی که با کمک تکنیکهای کمک باروری باردار شدند و در هفته 16 بارداری قرار دارند. معیارهای خروج: حاملگیهای دوقلو و چند قلو، سابقه زایمان زودرس، سابقه سقط، سابقه بیماریهای مزمن مانند دیابت، فشار خون، هیپوتیروئیدی یا هیپرتیروئیدی، مشکلات آناتومیکی رحم
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Intervention group: intramuscularly injection of 250 mg17-α hydroxy progesterone from16 to 36 weeks of gestation
Control group: intramuscularly injection of 250 mg placebo from16 to 36 weeks of gestation
Intervention group: intramuscularly injection of 250 mg17-α hydroxy progesterone from16 to 36 weeks of gestation Control group: intramuscularly injection of 250 mg placebo from16 to 36 weeks of gestation
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گروه مداخله: تزریق داخل عضلانی 250 میلی گرم 17-الفا هیدروکسی پروژسترون از هفته 16 تا 36 بارداری
گروه کنترل: تزریق داخل عضلانی 250 میلی گرم پلاسبو از هفته 16 تا 36 بارداری
گروه مداخله: تزریق داخل عضلانی 250 میلی گرم 17-الفا هیدروکسی پروژسترون از هفته 16 تا 36 بارداری گروه کنترل: تزریق داخل عضلانی 250 میلی گرم پلاسبو از هفته 16 تا 36 بارداری
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Preterm labor and the second trimester abortion
Preterm labor and the second trimester abortion
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زایمان زودرس وسقط سه ماهه دوم
زایمان زودرس وسقط سه ماهه دوم
General information
1
1
1
1
N/A
2
na2
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99
99
2012-03-05, 1390/12/15
2011-03-30, 1390/01/10
20122011-03-0530 00:00:00
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2010-10-23, 1389/08/01
2010-10-23 00:00:00
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2011-08-30, 1390/06/08
2011-08-30 00:00:00
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2011-10-28, 1390/08/06
2011-10-28 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
Pregnancy using ART
Gestational age of 16 weeks
Using progesterone for luteal phase support
Pregnancy using ART Gestational age of 16 weeks Using progesterone for luteal phase support
بارداری با استفاده ازتکنیکهای کمک باروری
سن حاملگی 16 هفته
دریافت پروژسترون برای حمایت فاز لوتئال
بارداری با استفاده ازتکنیکهای کمک باروری سن حاملگی 16 هفته دریافت پروژسترون برای حمایت فاز لوتئال
Twin or multiple pregnancies
History of preterm labor
History of previous abortion
History of chronic diseases such as Diabetes mellitus, Hypertention, and Hypo or Hyperthyroidism
Uterine anatomical problems
Twin or multiple pregnancies History of preterm labor History of previous abortion History of chronic diseases such as Diabetes mellitus, Hypertention, and Hypo or Hyperthyroidism Uterine anatomical problems
حاملگی دوقلو یا چند قلو
سابقه زایمان زودرس
سابقه سقط قبلی
سابقه بیماریهای مزمن مانند دیابت، فشار خون، هیپو یا هیپرتیروئیدی
مشکلات اناتومیکی رحم
حاملگی دوقلو یا چند قلو سابقه زایمان زودرس سابقه سقط قبلی سابقه بیماریهای مزمن مانند دیابت، فشار خون، هیپو یا هیپرتیروئیدی مشکلات اناتومیکی رحم
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In this trial, 99 women who conceived through ART at 16th weeks of pregnancy 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, 99 women who conceived through ART at 16th weeks of pregnancy 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 99 زن باردار شده به روشهای کمک باروری در هفته 16 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 99 زن باردار شده به روشهای کمک باروری در هفته 16 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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The patients and statistical analyzer both were blind about the drug or placebo. In placebo group injections were done by a drug similar in shape and volume, but without progesterone which was prepared by the same company as placebo. All injections have done by trained nurses who were blinded about the type of drugs.
The patients and statistical analyzer both were blind about the drug or placebo. In placebo group injections were done by a drug similar in shape and volume, but without progesterone which was prepared by the same company as placebo. All injections have done by trained nurses who were blinded about the type of drugs.
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بیماران و آنالیز کننده دیتا هر دو نسبت به گروه مطالعه و پلاسبو کور نگه داشته شده بودند. در گروه پلاسبو تزریقات با استفاده از یک داروی شبیه به داروی گروه مورد در شکل و حجم ولی بدون پروژسترون و تهیه شده بوسیله همان کارخانه انجام شد. تمام تزریقات بوسیله یک پرستار تعلیم داده شده و کور نگه داشته شده نسبت به نوع دارو انجام شد.
بیماران و آنالیز کننده دیتا هر دو نسبت به گروه مطالعه و پلاسبو کور نگه داشته شده بودند. در گروه پلاسبو تزریقات با استفاده از یک داروی شبیه به داروی گروه مورد در شکل و حجم ولی بدون پروژسترون و تهیه شده بوسیله همان کارخانه انجام شد. تمام تزریقات بوسیله یک پرستار تعلیم داده شده و کور نگه داشته شده نسبت به نوع دارو انجام شد.
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Primary outcomes
#1
etiology of preterm labour
Etiology of preterm labour
etiologyEtiology of preterm labour
weekly from16-36weeks of gestations
Weekly from16-36weeks of gestations
weeklyWeekly from16-36weeks of gestations
Secondary outcomes
#1
Only the end of gestation
After live birth
Only the end of gestationAfter live birth
یکبار درانتهای بارداری
پس از تولد زنده
یکبار درانتهای بارداریپس از تولد زنده
#2
birth weigh
Neonatal birth weigh
Neonatal birth weigh
وزن نوزاد
وزن هنگام تولد نوزاد
وزن هنگام تولد نوزاد
Only the end of gestation
After live birth
Only the end of gestationAfter live birth
فقط درانتهای بارداری
پس از تولد زنده
فقط درانتهای بارداریپس از تولد زنده
#3
drug complication
Drug complication
drugDrug complication
weekly from16-36 weeks of gestation
Weekly from16-36 weeks of gestation
weeklyWeekly from16-36 weeks of gestation
Recruitment centers
#1
Name of recruitment center - English: Research and Clinical Centre for Infertility of Yazd
Name of recruitment center - Persian: مرکزتحقیقاتی و بالینی ناباروری یزد
Full name of responsible person - English: Dr. Abbas Aflatonian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Street address - English: Research and Clinical Centre for Infertility, Bouali Ave, Safaeyeh, Yazd
Street address - Persian: یزد، خیابان بوعلی، صفائیه، مرکز پژوهشی درمانی نازایی 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 Centre for Infertility of Yazd
Name of recruitment center - Persian: مرکزتحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Dr. Abbas Aflatonian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Street address - English: Research and Clinical Centre for Infertility, Bouali Ave, Safaeyeh, Yazd
Street address - Persian: یزد، خیابان بوعلی، صفائیه، مرکز پژوهشی درمانی نازایی 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_aflatoonian@yahoo.com
Web page address:
Name of recruitment center - English: Research and Clinical Centre for Infertility of Yazd Name of recruitment center - Persian: مرکزتحقیقاتی و بالینیدرمانی ناباروری یزد Full name of responsible person - English: Dr. Abbas Aflatonian Full name of responsible person - Persian: دکتر عباس افلاطونیان Street address - English: Research and Clinical Centre for Infertility, Bouali Ave, Safaeyeh, Yazd Street address - Persian: یزد، خیابان بوعلی، صفائیه، مرکز پژوهشی درمانی نازایی 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_aflatoonian@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Shahid Sadoughi University of Medical Siences of Yazd
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr. Masood Mirzaiy
Full name of responsible person - Persian: دکتر مسعود میرزایی
Street address - English: Central Committee of Medical University, Bahonar sq, Yazd
Street address - Persian: یزد، میدان باهنر، سازمان مرکزی دانشگاه علوم پزشکی شهید صدوقی یزد
City - English: Yazd
City - Persian: یزد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahid Sadoughi University of Medical Siences of Yazd
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Dr. Masood Mirzaie
Full name of responsible person - Persian: دکتر مسعود میرزایی
Street address - English: Central Committee of Medical University, Bahonar sq, Yazd
Street address - Persian: یزد، میدان باهنر، سازمان مرکزی دانشگاه علوم پزشکی شهید صدوقی یزد
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: Shahid Sadoughi University of Medical Siences of Yazd Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید صدوقی یزد Full name of responsible person - English: Dr. Masood MirzaiyMirzaie Full name of responsible person - Persian: دکتر مسعود میرزایی Street address - English: Central Committee of Medical University, Bahonar sq, Yazd Street address - Persian: یزد، میدان باهنر، سازمان مرکزی دانشگاه علوم پزشکی شهید صدوقی یزد City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8916978477 Phone: +98 35 3724 0171 Fax: Email: dvc.research@ssu.ac.ir Web page address:
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Public
public
empty
Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Reseach and Clinical Centre for Infertility of Yazd
Name of organization / entity - Persian: مرکز تحقیقاتی و بالینی ناباروری یزد
Full name of responsible person - English: Dr. Hoora Amuzegar
Full name of responsible person - Persian: دکتر حورا آموزگار
Position - English: Resident of Obstetrics and Gynecology
Position - Persian: رزیدنت زنان وزایمان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Reseach and Clinical Centre for Infertility, Bouali Ave, Safaeyeh
Street address - Persian: یزد، خیابان بوعلی، صفائیه، مرکز تحقیقاتی و بالینی ناباروری یزد
City - English: Yazd
City - Persian: یزد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 89195-999
Phone: +98 35182470856
Mobile: +98 912 353 0879
Fax: +98 82 47087
Email: amuzegarhoora@yahoo.com
Web page address: -
contact.organization_id:
Name of organization / entity - English: Reseach and Clinical Centre for Infertility of Yazd
Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Dr. Hoora Amuzegar
Full name of responsible person - Persian: دکتر حورا آموزگار
Position - English: Resident of Obstetrics and Gynecology
Position - Persian: رزیدنت زنان وزایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Reseach and Clinical Centre for Infertility, Bouali Ave, Safaeyeh
Street address - Persian: یزد، خیابان بوعلی، صفائیه، مرکز تحقیقاتی و درمانی ناباروری یزد
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35182470856
Mobile: +98 912 353 0879
Fax: +98 35 3824 7087
Email: amuzegarhoora@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Reseach and Clinical Centre for Infertility of Yazd Name of organization / entity - Persian: مرکز تحقیقاتی و بالینیدرمانی ناباروری یزد Full name of responsible person - English: Dr. Hoora Amuzegar Full name of responsible person - Persian: دکتر حورا آموزگار Position - English: Resident of Obstetrics and Gynecology Position - Persian: رزیدنت زنان وزایمان Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Reseach and Clinical Centre for Infertility, Bouali Ave, Safaeyeh Street address - Persian: یزد، خیابان بوعلی، صفائیه، مرکز تحقیقاتی و بالینیدرمانی ناباروری یزد City - English: Yazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 89195-9998916877391 Phone: +98 35182470856 Mobile: +98 912 353 0879 Fax: +98 82 4708735 3824 7087 Email: amuzegarhoora@yahoo.com Web page address: -
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Research and Clinical Centre for Infertility of Yazd
Name of organization / entity - Persian: مرکز تحقیقاتی وبالینی ناباروری یزد
Full name of responsible person - English: Dr. Abbas Aflatonian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Position - English: Obstetrics and Gynecologyst and Proffesor of Infertility
Position - Persian: پروفسور و متخصص زنان وزایمان وفوق تخصص نازایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Infertility Centre, Bouali Ave, Safaeyeh, Yazd
Street address - Persian: یزد، خیابان بوعلی، خیابان صفائیه، مرکز ناباروری یزد
City - English: Yazd
City - Persian: یزد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 89195-999
Phone: +98 35 1824 7085
Mobile: +98 913 151 5349
Fax: +98 35 1824 7087
Email: abbas_aflatonian@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Research and Clinical Centre for Infertility of Yazd
Name of organization / entity - Persian: مرکز تحقیقاتی ودرمانی ناباروری یزد
Full name of responsible person - English: Dr. Abbas Aflatonian
Full name of responsible person - Persian: دکتر عباس افلاطونیان
Position - English: Obstetrics and Gynecologyst and Proffesor of Infertility
Position - Persian: پروفسور و متخصص زنان وزایمان وفوق تخصص نازایی
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Infertility Centre, Bouali Ave, Safaeyeh, Yazd
Street address - Persian: یزد، خیابان بوعلی، خیابان صفائیه، مرکز ناباروری یزد
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Mobile: +98 913 151 5349
Fax: +98 35 3824 7087
Email: abbas_aflatonian@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Research and Clinical Centre for Infertility of Yazd Name of organization / entity - Persian: مرکز تحقیقاتی وبالینیودرمانی ناباروری یزد Full name of responsible person - English: Dr. Abbas Aflatonian Full name of responsible person - Persian: دکتر عباس افلاطونیان Position - English: Obstetrics and Gynecologyst and Proffesor of Infertility Position - Persian: پروفسور و متخصص زنان وزایمان وفوق تخصص نازایی Latest degree: sub_specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Infertility Centre, Bouali Ave, Safaeyeh, Yazd Street address - Persian: یزد، خیابان بوعلی، خیابان صفائیه، مرکز ناباروری یزد City - English: Yazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 89195-9998916877391 Phone: +98 35 18243824 7085 Mobile: +98 913 151 5349 Fax: +98 35 18243824 7087 Email: abbas_aflatonian@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Research and Clinical Centre for Infertility of Yazd
Name of organization / entity - Persian: مرکز تحقیقاتی وبالینی ناباروری یزد
Full name of responsible person - English: ِDr. Hoora Amuzegar
Full name of responsible person - Persian: دکتر حورا آموزگار
Position - English: Resident of Obstetrics and Gynecology
Position - Persian: رزیدنت زنان وزایمان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Infertility Centre, Bouali Ave, Safaeyeh
Street address - Persian: یزد، خیابان بوعلی، خیابان صفائیه، مرکز ناباروری یزد
City - English: Yazd
City - Persian: یزد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 89195-999
Phone: +98 35 1824 7085
Mobile: +98 912 353 0879
Fax: +98 82 47087
Email: amuzegarhoora@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Research and Clinical Centre for Infertility of Yazd
Name of organization / entity - Persian: مرکز تحقیقاتی ودرمانی ناباروری یزد
Full name of responsible person - English: ِDr. Hoora Amuzegar
Full name of responsible person - Persian: دکتر حورا آموزگار
Position - English: Resident of Obstetrics and Gynecology
Position - Persian: رزیدنت زنان وزایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Infertility Centre, Bouali Ave, Safaeyeh
Street address - Persian: یزد، خیابان بوعلی، خیابان صفائیه، مرکز ناباروری یزد
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Mobile: +98 912 353 0879
Fax: +98 35 3824 7087
Email: amuzegarhoora@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Research and Clinical Centre for Infertility of Yazd Name of organization / entity - Persian: مرکز تحقیقاتی وبالینیودرمانی ناباروری یزد Full name of responsible person - English: ِDr. Hoora Amuzegar Full name of responsible person - Persian: دکتر حورا آموزگار Position - English: Resident of Obstetrics and Gynecology Position - Persian: رزیدنت زنان وزایمان Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Infertility Centre, Bouali Ave, Safaeyeh Street address - Persian: یزد، خیابان بوعلی، خیابان صفائیه، مرکز ناباروری یزد City - English: Yazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 89195-9998916877391 Phone: +98 35 18243824 7085 Mobile: +98 912 353 0879 Fax: +98 82 4708735 3824 7087 Email: amuzegarhoora@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.
983538247085
پژوهشکده علوم تولید مثل یزد، خیابان بوعلی، یزد، ایران. 983538247085
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
Evaluation of the effectiveness of 17 alpha-hydroxyprogestrone on decreasing abortion and preterm labor
Design
Women who met inclusion criteria, were informed about the trial design and signed a written consent form. Participants were consecutively enrolled the study and randomly divided into two groups using randomized list. Participants enrolled in a randomized parallel, double-blind, phase 2 clinical trial with control group. Randomization was performed using random number table
Settings and conduct
Women who got pregnant after ART at Yazd Infertility Center and were at 16th week of gestational age were randomly divided into two groups of 7-α hydroxy progesterone and placebo. A double blind trial was performed using placebo (similarity in amount, shape and administration method). patients and data analyzer were blinded to the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who got pregnant after ART and were at 16 weeks of gestational age.
Exclusion criteria: Twin or multiple pregnancies; history of preterm labor; history of previous abortion; history of chronic diseases (Diabetes mellitus, Hypertention, and Hypo or Hyperthyroidism); uterine anatomical problems
Intervention groups
Intervention group: intramuscularly injection of 250 mg17-α hydroxy progesterone from16 to 36 weeks of gestation
Control group: intramuscularly injection of 250 mg placebo from16 to 36 weeks of gestation
Main outcome variables
Preterm labor and the second trimester abortion
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:IRCT2012101611132N1
Registration date:2012-12-24, 1391/10/04
Registration timing:retrospective
Last update:2021-04-16, 1400/01/27
Update count:2
Registration date
2012-12-24, 1391/10/04
Registrant information
Name
Hoora Amuzegar
Name of organization / entity
Yazd University of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 25 1772 2560
Email address
abbas_aflatonian@yahoo.com
Recruitment status
Recruitment complete
Funding source
ُShahid Sadoughi University of Medical Siences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-03-30, 1390/01/10
Actual recruitment start date
2010-10-23, 1389/08/01
Actual recruitment end date
2011-08-30, 1390/06/08
Trial completion date
2011-10-28, 1390/08/06
Scientific title
Evaluation the Effect of 17 alpha-hydroxyprogestrone caproate on dcreasing preterm labour and second trimester miscarriage in women pregnant with ART
Public title
The effect of progestrone on preterm labour in patient who are pregnant with ART teqnique
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy using ART
Gestational age of 16 weeks
Using progesterone for luteal phase support
Exclusion criteria:
Twin or multiple pregnancies
History of preterm labor
History of previous abortion
History of chronic diseases such as Diabetes mellitus, Hypertention, and Hypo or Hyperthyroidism
Uterine anatomical problems
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
106
Actual sample size reached:
99
Randomization (investigator's opinion)
Randomized
Randomization description
In this trial, 99 women who conceived through ART at 16th weeks of pregnancy 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)
Double blinded
Blinding description
The patients and statistical analyzer both were blind about the drug or placebo. In placebo group injections were done by a drug similar in shape and volume, but without progesterone which was prepared by the same company as placebo. All injections have done by trained nurses who were blinded about the type of drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadooghi medical university of Yazd
Street address
Central Committee of Medical University, Bahonar sq, Yazd
City
Yazd
Province
Yazd
Postal code
7240171-5
Approval date
2010-10-27, 1389/08/05
Ethics committee reference number
پ/17/1/81633
Health conditions studied
1
Description of health condition studied
preterm labour
ICD-10 code
O60,O75
ICD-10 code description
complication of labour and delivery
Primary outcomes
1
Description
Labour under37week/34-37week-32-34week and second trimestre abortion
Timepoint
weekly from16-36weeks of gestation
Method of measurement
Quastisonaries
2
Description
Etiology of preterm labour
Timepoint
Weekly from16-36weeks of gestations
Method of measurement
Quastionaries
Secondary outcomes
1
Description
NICU admission
Timepoint
After live birth
Method of measurement
Quastionaries
2
Description
Neonatal birth weigh
Timepoint
After live birth
Method of measurement
Quastionaries
3
Description
Drug complication
Timepoint
Weekly from16-36 weeks of gestation
Method of measurement
Quastionaries
Intervention groups
1
Description
control group:drug with all chachtristic of of 17alpha- hydroxyprogestrone caproate:only without efficient material of this drug:intramusculary injected from16-36weeks of gestation
Category
Placebo
2
Description
Drug group:17alpha-hydroxyprogestrone caproate(FEMOLIFE)intramusculary injected from16-36weeks of gestation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Centre for Infertility of Yazd
Full name of responsible person
Dr. Abbas Aflatonian
Street address
Research and Clinical Centre for Infertility, Bouali Ave, Safaeyeh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas_aflatoonian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Siences of Yazd
Full name of responsible person
Dr. Masood Mirzaie
Street address
Central Committee of Medical University, Bahonar sq, Yazd
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
Shahid Sadoughi University of Medical Siences of Yazd
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
Reseach and Clinical Centre for Infertility of Yazd
Full name of responsible person
Dr. Hoora Amuzegar
Position
Resident of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Reseach and Clinical Centre for Infertility, Bouali Ave, Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35182470856
Fax
+98 35 3824 7087
Email
amuzegarhoora@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Centre for Infertility of Yazd
Full name of responsible person
Dr. Abbas Aflatonian
Position
Obstetrics and Gynecologyst and Proffesor of Infertility
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Centre, Bouali Ave, Safaeyeh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas_aflatonian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical Centre for Infertility of Yazd
Full name of responsible person
ِDr. Hoora Amuzegar
Position
Resident of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Centre, Bouali Ave, Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
amuzegarhoora@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