History
# Registration date Revision Id
2 2019-01-11, 1397/10/21 75260
1 2017-03-08, 1395/12/18 25167
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  • Protocol summary

    The aim of this study is to evaluate the effect of dietary based on traditional medicine on the results of assisted reproductive technology (ART). For this purpose, the traditional meal plan is designed based on the Iranian traditional medicine and its evaluation is performed by using a randomized clinical trial. The candidates of IVF/ICSI referring to Shahrekord infertility center, who causes of their infertility are not anatomical, uterine fibroids or hydrosalpinx but are ovarian endometriosis or unexplained. The patients must not be diabetic, smoker or alcoholic. After obtaining written informed consent from the patients, they will be examined and demographic and food frequency questionnaires will be completed for all of them. Then, the patients are assigned to intervention and control groups based on stratified random allocation rule in four age groups of under 30, 30-34, 35-37 and 38-40 years old using block size of six. Recommendations to protect the health and nutrition recommendations based on traditional medicine will be educated to the case group and the usual dietary recommendations based on conventional medicine and public health will be educated to the control group. The duration of treatment will be two to three months and the patients will be followed up to obey and use the recommendations. At the end of the study, IVF success will be measured in two groups. The response variables in this study are the outcomes of IVF/ICSI, including: oocytes quality, embryo quality, implantation rate, fertility rate, chemical and clinical pregnancy.
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    هدف از این مطالعه، بررسی اثر رژیم غذایی مبتنی بر طب سنتی بر نتایج روشهای کمک باروری می باشد. برنامه غذایی مبتنی برطب سنتی از منابع طب سنتی ایران استخراج می گردد و ارزیابی آن با یک مطالعه کارآزمایی بالینی تصادفی انجام میشود. در ابتدا، بیماران کاندیدای IVF/ICSI مراجعه کننده به مرکز ناباروری شهرکرد که ناباروری آنها به علل آناتومیک، فیبروم رحمی یا هیدروسالپنکس نباشد بلکه تخمدانی، آندومتریوز یا توجیه نشده باشد با شرایط عدم ابتلا به دیابت و عدم استعمال سیگار و مشروبات الکلی به روش نمونه گیری در دسترس وارد مطالعه خواهند شد. پس از اخذ رضایت آگاهانه کتبی از بیماران و معاینه کامل، پرسشنامه دموگرافیک و بسامد خوراک برای همه بیماران تکمیل خواهد شد. بیماران به روش تصادفی طبقه‏ای بر حسب چهار گروه سنی زیر 30 ، 34-30 ،37-35 و 38-40 سال در بلوکهای شش نفره به گروههای مورد و شاهد تخصیص می یابند. به گروه مورد تدابیر حفظ سلامتی و توصیه ‏های غذایی مبتنی بر طب سنتی و به گروه کنترل توصیه ‏های غذایی معمول بر اساس طب رایج و توصیه‏های عمومی سلامتی آموزش داده خواهد شد. مدت زمان رژیم غذایی دو تا سه ماه خواهد بود و افراد دو گروه برای اجرای توصیه ‏های غذایی پیگیری خواهند شد. در پایان مطالعه موفقیت IVF در دو گروه اندازه گیری می‏گردد. متغیرهای پاسخ در این مطالعه پیامد IVF/ICSI شامل: کیفیت تخمک، کیفیت جنین، نرخ لانه گزینی، نرخ باروری، حاملگی شیمیایی و حاملگی بالینی می‏باشد.
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    the effects of Iranian Traditional Medicine diet on invitro fertilization outcomes
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    تاثیر رژیم مبتنی بر طب سنتی بر نتایج لقاح آزمایشگاهی
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    A Randomized Controlled Trial
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    کارآزمایی بالینی تصادفی دارای گروه کنترل
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    The study was designed as a randomized clinical trial. Participants in the study were referred to Hazrat Zahra infertility treatment center affiliated to Shahrekord University of Medical Sciences. At the beginning of the study, the volunteers were examined by a practitioner to qualify for the study. The control group received routine healthcare and modern dietary recommendations and the intervention group was advised to observe health principles and nutritional recommendations based on ITM sources. Each individual in the intervention group was trained on traditional dietary advices , foods preparation, nutritionally-prohibited foods and essential health recommendations by the researcher. They also received a training guidance text on the above- mentioned points for further self-learning.
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    مطالعه به صورت کارآزمایی بالینی طراحی شد. مکان انجام مطالعه درمانگاه ناباروری حضرت زهرا(س) شهرکرد وابسته به دانشگاه علوم پزشکی شهرکرد بود. به گروه شاهد توصیه های عمومی سلامتی(routin health care) و توصیه های غذایی طب مدرن و به گروه مداخله توصیه های حفظ سلامتی و توصیههای غذایی مبتنی بر منابع طب ایرانی داده شد. افراد در هر دو گروه برای اجرای این توصیه های غذایی پیگیری شدند. تک تک افراد گروه مداخله توسط پژوهشگر در خصوص توصیه های غذایی طب سنتی، نحوه تهیه غذا، پرهیزات غذایی و تدابیر حفظ الصحه آموزش دیده و راهنمایی های لازم را کسب نمودند همچنین جزوات آموزش در خصوص موارد ذکر شده جهت مطالعه بیشتر در اختیار آنها قرار گرفت. افراد گروه مداخله به دقت پیگیری میشدند و میزان و نحوه رعایت رژیم غذایی بر اساس پرسشنامه یادآمد 24 ساعته خوراک که سه مرتبه به ازای هر دو هفته(یک روز تعطیل و دو روز غیر تعطیل) برای آنها تکمیل می‏گردید، بررسی شد.
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    The inclusion criteria: infertile women with ovulatory problems or endometriosis or ideophatic infertility, age 20 to 40 years, giving written consent to participate in the study. Women who had infertility with anatomical causes, infertility of their husbands, having uterine myoma or hydrosalpinx, smoking, drinking alcohol, and diabetes mellitus were not included. Exclusion criteria were as follow: lack of interest or cooperation during the study, refusal to go through IVF / ICSI.
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    - زنان بالغ - سن بین 20 تا 40 سال - رضایتمندی برای شرکت در مطالعه - زنان نابارور با مشکلات تخمدانی یا ناباروری با علل توجیه نشده، آندومتریوز - عدم ابتلا به ناباروری با علل آناتومیک - عدم ابتلا به ناباروری با علل صرفا مردانه - عدم ابتلا به میوم رحمی و هیدروسالپنکس - عدم استعمال سیگار - عدم مصرف مشروبات الکلی - عدم ابتلا به دیابت
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    Each individual in the intervention group was trained on traditional dietary advices ,prohibited foods and essential health recommendations.
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    به گروه مداخله توصیه های حفظ سلامتی و توصیه های غذایی مبتنی بر منابع طب ایرانی داده شد. به این افراد پرهیزات غذایی و تدابیر حفظ الصحه آموزش داده شد.
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    The primary outcomes of the study were the rate of sponteneous pregnancy and clinical pregnancy, and the secondary outcomes included ovum number, mature ovum number, embryo number, embryo quality, fertilization rate, implantation rate, and chemical pregnancy.
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    پیامد های اصلی مورد مطالعه عبارت بودند از : میزان بارداری خود به خودی، تعداد و کیفیت تخمک، تعداد و کیفیت جنین، نرخ باروری، نرخ لانه گزینی و بارداری شیمیایی و پیامد اولیه، بارداری کلینیکی میباشد.
  • General information

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    2017-11-20, 1396/08/29
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    2018-03-11, 1396/12/20
    infertile women with ovulatory problems or endometriosis or idiopathic infertility and endometriosis
    age 20 to 40 years
    giving written consent to participate in the study
    no infertility with anatomical causes
    no infertility of their husbands
    not having uterine myoma or hydrosalpinx
    no smoking
    no alcohol drinking
    not diabetic
    زنان نابارور با مشکلات تخمدانی یا ناباروری با علل توجیه نشده، آندومتریوز-
    سن بین 20 تا 40 سال
    رضایتمندی برای شرکت در مطالعه
    عدم ابتلا به ناباروری با علل آناتومیک
    عدم ابتلا به ناباروری با علل صرفا مردانه
    عدم ابتلا به میوم رحمی و هیدروسالپنکس
    عدم استعمال سیگار
    عدم مصرف الکل
    دیابت نداشتن
    lack of interest or cooperation during the study,
    refusal to go through IVF / ICSI.
    عدم علاقمندی یا همکاری بیمار در طول مطالعه
    انصراف بیمار از انجام IVF/ICSI
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    In the order of entry to study based on a permuted blocks of size four, the patients in each four age groups of under 30, 30-34, 35-37, and 38-40 years were randomly assigned to the intervention and control groups. The random allocation sequence was generated by an investigator who was not involved in eliciting data or conducting the study.
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    بیماران به ترتیب ورود به مطالعه به روش بلوک بندی تصادفی طبقه ای در چهار گروه سنی زیر 30 ، 34-30 ،37-35 و 38-40 سال در بلوکهای چهار نفره به گروه های رژیم غذایی مبتنی بر طب ایرانی و رژیم غذایی معمولی به تصادف به کمک نرم افزار تخصیص یافتند. تولید دنباله تصادفی توسط فردی که در جمع آوری داده ها و هدایت مطالعه نقشی نداشت انجام گرفت.
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  • Ethics committees

    #1
    2017-01-16, 1395/10/27
    2017-01-15, 1395/10/26
    IR.IUMS.REC 1395.9221309206
    IR.IUMS.REC1395.9221309206
  • Intervention groups

    #1
    Intervention group: Diet based on traditional medicine in the intervention group for 2 to 3 months before IVF/ICSI. Intervention group: Diet based on traditional medicine in the intervention group for 2 to 3 months before IVF/ICSI. The recommended foods are those that help gestation, enhance libido, are semen producer, resolve the liver and spleen obstruction, strengthen uterine and main body organs including the brain, liver and heart and they have been used in infertility treatments. These food choices are derived from traditional medicine literature sources and are recommended to be included in patients’ meal plan (breakfast, lunch, dinner and snacks).
    Intervention group: Diet based on traditional medicine in the intervention group for 2 to 3 months before IVF/ICSI. The recommended foods are those that help gestation, enhance libido, are semen producer, resolve the liver and spleen obstruction, strengthen uterine and main body organs including the brain, liver and heart and they have been used in infertility treatments. These food choices are derived from traditional medicine literature sources and are recommended to be included in patients’ meal plan (breakfast, lunch, dinner and snacks).
  • Recruitment centers

    #1
    Name of recruitment center - English: Shahrekord Infertility Center of Hazrat Zahra
    Name of recruitment center - Persian: مرکز ناباروری حضرت زهرا(س) شهرکرد
    Full name of responsible person - English: Maryam Nemati, Gynecologist and infertility specialist
    Full name of responsible person - Persian: دکتر مریم نعمتی متخصص زنان فوق تخصص نازایی
    Street address - English: Infertility Center of Hazrat Zahra, Next to the Imam Hassan mosque, West Saadi Street, Shahrekord
    Street address - Persian: شهرکرد، خیابان سعدی غربی، جنب مسجد امام حسن، مرکز ناباروری حضرت زهرا(س)
    City - English: Shahrekord
    City - Persian: شهرکرد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Shahrekord Infertility Center of Hazrat Zahra
    Name of recruitment center - Persian: مرکز ناباروری حضرت زهرا(س) شهرکرد
    Full name of responsible person - English: Maryam Nemati, Gynecologist and infertility specialist
    Full name of responsible person - Persian: دکتر مریم نعمتی متخصص زنان فوق تخصص نازایی
    Street address - English: Infertility Center of Hazrat Zahra, Next to the Imam Hassan mosque, West Saadi Street, Shahrekord
    Street address - Persian: شهرکرد، خیابان سعدی غربی، جنب مسجد امام حسن، مرکز ناباروری حضرت زهرا(س)
    City - English: Shahrekord
    City - Persian: شهرکرد
    Province: Chahar-Mahal-va-Bakhtiari
    Country: Iran (Islamic Republic of)
    Postal code: 8816866659
    Phone: +98 38 3222 0478
    Fax:
    Email: mertanem@yahoo.co.uk
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Research Institute for Islamic and Complementary Medicine (RICM)
    Name of organization / entity - Persian: مؤسسه مطالعات تاریخ پزشکی ، طب اسلامی و مکمل
    Full name of responsible person - English: Fataneh Hashem Dabaghian
    Full name of responsible person - Persian: دکتر فاطمه هاشم دباغیان
    Street address - English: 9, Pirnia Allay, Lalezar Street, Jomhuri Street
    Street address - Persian: خیابان جمهوری، خیابان لاله زار، انتهای کوچه پیرنیا،پلاک 9
    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: Research Institute for Islamic and Complementary Medicine (RICM)
    Name of organization / entity - Persian: مؤسسه مطالعات تاریخ پزشکی ، طب اسلامی و مکمل
    Full name of responsible person - English: Fataneh Hashem Dabaghian
    Full name of responsible person - Persian: دکتر فاطمه هاشم دباغیان
    Street address - English: 9, Pirnia Allay, Lalezar Street, Jomhuri Street
    Street address - Persian: خیابان جمهوری، خیابان لاله زار، انتهای کوچه پیرنیا،پلاک 9
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 114587111
    Phone: +98 21 5563 9724
    Fax:
    Email: fataneh.dabaghian@yahoo.com
    Web page address:
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    Academic
    #2
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for research of Iran University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Ali Javad Musavi
    Full name of responsible person - Persian: دکترسید علی جواد موسوی
    Street address - English: Iran University of Medical Sciences, Besides Milad Tower, Hemmat Highway, Tehran
    Street address - Persian: بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
    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: Vice Chancellor for research of Iran University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Ali Javad Musavi
    Full name of responsible person - Persian: دکترسید علی جواد موسوی
    Street address - English: Iran University of Medical Sciences, Besides Milad Tower, Hemmat Highway, Tehran
    Street address - Persian: بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 8670 2550
    Fax:
    Email: Dr_moosavi@yahoo.com
    Web page address:
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    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Zeinab Alibeigi Beni
    Full name of responsible person - Persian: زینب علی بیگی بنی
    Position - English: PhD Student of Traditional Medicine
    Position - Persian: دانشجوی PhD طب سنتی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
    Street address - Persian: تهران، خیابان وحدت اسلامی، ضلع جنوبی پارک شهر،خیابان بهشت، دانشکده طب سنتی
    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 5563 9724
    Mobile: +98 913 184 7190
    Fax: -
    Email: alibeigibeni.zeinab@gmail.com; zalibeigibeni@yahoo.com
    Web page address: -
    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Zeinab Alibeigi Beni
    Full name of responsible person - Persian: زینب علی بیگی بنی
    Position - English: PhD Student of Traditional Medicine
    Position - Persian: دانشجوی PhD طب سنتی
    Latest degree: med_doctor
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
    Street address - Persian: تهران، خیابان وحدت اسلامی، ضلع جنوبی پارک شهر،خیابان بهشت، دانشکده طب سنتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: +98 21 5563 9724
    Mobile: +98 913 184 7190
    Fax: +98 21 5561 3191
    Email: alibeigibeni.zeinab@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Mojgan Tansaz
    Full name of responsible person - Persian: مژگان تن ساز
    Position - English: Traditional Medicine Assistant Professor
    Position - Persian: استادیار طب سنتی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional Medicine, Shams Allay, Tavanir Opposite, Valiasr Street, Tehran
    Street address - Persian: تهران، خیابان ولیعصر، روبروی توانیر، کوچه شمس، دانشکده طب سنتی
    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 8877 3521
    Mobile: +98 912 313 6276
    Fax: -
    Email: tansaz_mojgan@yahoo.com
    Web page address: -
    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Mojgan Tansaz
    Full name of responsible person - Persian: مژگان تن ساز
    Position - English: Traditional Medicine Assistant Professor
    Position - Persian: استادیار طب سنتی
    Latest degree: phd
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional Medicine, Shams Allay, Tavanir Opposite, Valiasr Street, Tehran
    Street address - Persian: تهران، خیابان ولیعصر، روبروی توانیر، کوچه شمس، دانشکده طب سنتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: +98 21 8877 3521
    Mobile: +98 912 313 6276
    Fax: +98 21 5561 3191
    Email: tansaz_mojgan@yahoo.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Efat Jafari Dehkordi
    Full name of responsible person - Persian: عفت جعفری دهکردی
    Position - English: Traditional Medicine Assistant Professor
    Position - Persian: استادیار طب سنتی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
    Street address - Persian: تهران، خیابان وحدت اسلامی، ضلع جنوبی پارک شهر،خیابان بهشت، دانشکده طب سنتی
    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 5563 9667
    Mobile: +98 912 547 7323
    Fax: -
    Email: efjafari@yahoo.com
    Web page address: -
    contact.organization_id:
    Name of organization / entity - English: Iran University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Efat Jafari Dehkordi
    Full name of responsible person - Persian: عفت جعفری دهکردی
    Position - English: Traditional Medicine Assistant Professor
    Position - Persian: استادیار طب سنتی
    Latest degree: phd
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
    Street address - Persian: تهران، خیابان وحدت اسلامی، ضلع جنوبی پارک شهر،خیابان بهشت، دانشکده طب سنتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: +98 21 5563 9667
    Mobile: +98 912 547 7323
    Fax: +98 21 5561 3191
    Email: efjafari@yahoo.com
    Web page address:
  • Sharing plan

    yes
    yes
    yes
    yes
    yes
    yes
    yes
    empty
    Data will be sent to researchers upon request.
    empty
    در صورت درخواست از طرف محققین داده ها ارسال خواهد شد.
    empty
    After publication the results of study
    empty
    پس از چاپ نتایج مطالعه
    empty
    Researchers
    empty
    محققین
    empty
    for systematic or meta-analysis study
    empty
    برای مطالعات مرور سیستماتیک یا متا آنالیز
    empty
    ِDr Mojgan Tansaz tansaz_mojgan@yahoo.com
    empty
    دکتر مژگان تن ساز tansaz_mojgan@yahoo.com
    empty
    E-mail correspondence with the principle researcher
    empty
    مکاتبه توسط ایمیل با مجری طرح
    empty
    There are no patient names in the data file and numerical codes are used to identify them.
    empty
    در فایل داده ها اسامی بیماران وجود ندارد و برای شناسایی از کدهای عددی استفاده شده است.
  • Trial results

    empty
    The number of ovum, mature ovum number, embryos number, embryo quality and fertilization rate were significantly higher in the intervention group than control group (for all items; P<0.05). Overall pregnancy rate was significantly higher in the intervention group (35.2% vs. 12.4%; odds ratio [OR], 3.8; 95% confidence interval [CI] 1.8-8.3). The intervention group had higher rate of getting spontaneous pregnancy than the control group (20.9% vs. 2.2%; odds ratio [OR], 11.5; 95% confidence interval [CI] 2.6-50.9). Chemical pregnancy was significantly higher in the intervention group (64% vs. 27.5%; odds ratio [OR], 4.7; 95% confidence interval [CI] 1.9-11.6).
    empty
    . از نظر پیامدهای اصلی مطالعه، تعداد تخمک، تعداد تخمک بالغ، تعداد جنین، کیفت جنین، نرخ بارداری شیمیایی و نرخ باروری در گروه مداخله بطور معنی‌داری بیشتر از گروه کنترل بود (برای همه موارد، P <0.05). نرخ بارداری خود بخودی و نرخ حاملگی شیمیایی در گروه مداخله بطور معنی داری بیشتر بود. درمجموع نرخ بارداری حاصل از سه نوع بارداری خودبخودی، IUI و IVF در گروه مداخله بطور معنی داری بیشتر از گروه کنترل بود. اما از نظر پیامدهای نرخ لانه گزینی و بارداری کلینیکی تفاوت معنی داری بین دو گروه دیده نشد.

Protocol summary

Study aim
the effects of Iranian Traditional Medicine diet on invitro fertilization outcomes
Design
A Randomized Controlled Trial
Settings and conduct
The study was designed as a randomized clinical trial. Participants in the study were referred to Hazrat Zahra infertility treatment center affiliated to Shahrekord University of Medical Sciences. At the beginning of the study, the volunteers were examined by a practitioner to qualify for the study. The control group received routine healthcare and modern dietary recommendations and the intervention group was advised to observe health principles and nutritional recommendations based on ITM sources. Each individual in the intervention group was trained on traditional dietary advices , foods preparation, nutritionally-prohibited foods and essential health recommendations by the researcher. They also received a training guidance text on the above- mentioned points for further self-learning.
Participants/Inclusion and exclusion criteria
The inclusion criteria: infertile women with ovulatory problems or endometriosis or ideophatic infertility, age 20 to 40 years, giving written consent to participate in the study. Women who had infertility with anatomical causes, infertility of their husbands, having uterine myoma or hydrosalpinx, smoking, drinking alcohol, and diabetes mellitus were not included. Exclusion criteria were as follow: lack of interest or cooperation during the study, refusal to go through IVF / ICSI.
Intervention groups
Each individual in the intervention group was trained on traditional dietary advices ,prohibited foods and essential health recommendations.
Main outcome variables
The primary outcomes of the study were the rate of sponteneous pregnancy and clinical pregnancy, and the secondary outcomes included ovum number, mature ovum number, embryo number, embryo quality, fertilization rate, implantation rate, and chemical pregnancy.

General information

Reason for update
Acronym
-
IRCT registration information
IRCT registration number: IRCT2017013032245N2
Registration date: 2017-03-08, 1395/12/18
Registration timing: prospective

Last update: 2019-01-14, 1397/10/24
Update count: 1
Registration date
2017-03-08, 1395/12/18
Registrant information
Name
Zeinab Alibeigi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 9724
Email address
alibeigibeni.zeinab@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
2017-04-10, 1396/01/21
Actual recruitment end date
2017-11-20, 1396/08/29
Trial completion date
2018-03-11, 1396/12/20
Scientific title
Clinical trial comparing the effects of diet based on traditional medicine and usual diet on the results of in vitro fertilization for infertile women
Public title
The impact of diet based on Iranian Traditional Medicine on IVF/ICSI outcomes of infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
infertile women with ovulatory problems or endometriosis or idiopathic infertility and endometriosis age 20 to 40 years giving written consent to participate in the study no infertility with anatomical causes no infertility of their husbands not having uterine myoma or hydrosalpinx no smoking no alcohol drinking not diabetic
Exclusion criteria:
lack of interest or cooperation during the study, refusal to go through IVF / ICSI.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 124
Actual sample size reached: 180
Randomization (investigator's opinion)
Randomized
Randomization description
In the order of entry to study based on a permuted blocks of size four, the patients in each four age groups of under 30, 30-34, 35-37, and 38-40 years were randomly assigned to the intervention and control groups. The random allocation sequence was generated by an investigator who was not involved in eliciting data or conducting the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه ع پ ایران
Street address
تهران - بزرگراه همت - جنب برج میلاد - دانشگاه علوم پزشکی ایران
City
تهران
Province
Tehran
Postal code
1449614535
Approval date
2017-01-15, 1395/10/26
Ethics committee reference number
IR.IUMS.REC1395.9221309206

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
clinical pregnancy
Timepoint
3 mounts after intervention
Method of measurement
sonography

Secondary outcomes

1

Description
Oocyt quality
Timepoint
2-3 mounts after intervention
Method of measurement
Oocyt quality evaluation criteria

2

Description
Embryo quality
Timepoint
2-3 mounts after intervention
Method of measurement
Embryo quality evaluation criteria

3

Description
Endometrium tickness
Timepoint
2-3 mounts after intervention
Method of measurement
Sonography

4

Description
Implantation rate
Timepoint
2-3 mounts after intervention
Method of measurement
The number of gestational sac divided by the number of transferred embryos

5

Description
Fertility rate
Timepoint
2-3 mounts after intervention
Method of measurement
the number of oocytes fertilized divided by the number of oocytes inseminated

6

Description
Chemical pregnancy
Timepoint
2-3 mounts after intervention
Method of measurement
Serum Β-hCG meausurment

Intervention groups

1

Description
Intervention group: Diet based on traditional medicine in the intervention group for 2 to 3 months before IVF/ICSI. The recommended foods are those that help gestation, enhance libido, are semen producer, resolve the liver and spleen obstruction, strengthen uterine and main body organs including the brain, liver and heart and they have been used in infertility treatments. These food choices are derived from traditional medicine literature sources and are recommended to be included in patients’ meal plan (breakfast, lunch, dinner and snacks).
Category
Treatment - Other

2

Description
Control group: The usual daily diet in the control group for 2 to 3 months before IVF/ICSI.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Infertility Center of Hazrat Zahra
Full name of responsible person
Maryam Nemati, Gynecologist and infertility specialist
Street address
Infertility Center of Hazrat Zahra, Next to the Imam Hassan mosque, West Saadi Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816866659
Phone
+98 38 3222 0478
Fax
Email
mertanem@yahoo.co.uk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine (RICM)
Full name of responsible person
Fataneh Hashem Dabaghian
Street address
9, Pirnia Allay, Lalezar Street, Jomhuri Street
City
Tehran
Province
Tehran
Postal code
114587111
Phone
+98 21 5563 9724
Email
fataneh.dabaghian@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic and Complementary Medicine (RICM)
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Ali Javad Musavi
Street address
Iran University of Medical Sciences, Besides Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2550
Email
Dr_moosavi@yahoo.com
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 of Iran University of Medical Sciences
Proportion provided by this source
50
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
Iran University of Medical Science
Full name of responsible person
Zeinab Alibeigi Beni
Position
PhD Student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 5563 9724
Fax
+98 21 5561 3191
Email
alibeigibeni.zeinab@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Mojgan Tansaz
Position
Traditional Medicine Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine, Shams Allay, Tavanir Opposite, Valiasr Street, Tehran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8877 3521
Fax
+98 21 5561 3191
Email
tansaz_mojgan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Efat Jafari Dehkordi
Position
Traditional Medicine Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 5563 9667
Fax
+98 21 5561 3191
Email
efjafari@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
Data will be sent to researchers upon request.
When the data will become available and for how long
After publication the results of study
To whom data/document is available
Researchers
Under which criteria data/document could be used
for systematic or meta-analysis study
From where data/document is obtainable
ِDr Mojgan Tansaz tansaz_mojgan@yahoo.com
What processes are involved for a request to access data/document
E-mail correspondence with the principle researcher
Comments
There are no patient names in the data file and numerical codes are used to identify them.
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