History
# Registration date Revision Id
3 2023-05-21, 1402/02/31 267869
2 2022-03-19, 1400/12/28 220909
1 2016-12-08, 1395/09/18 23922
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  • Protocol summary

    The aims of this interventional study are to examine the effects of energy restricted low glycemic diet on hormonal and reproductive variables of PCOS women and to compare the effects of energy restricted diet on anthropometric and metabolic characteristics between women with or without PCOS. This study will be included 30 PCOS women and 30 controls matched for BMI and age and will be recruited using convenience sampling. The case group will be recruited from PCOS women aged between 18-40 years, attending Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences. Healthy controls will be 30 age and BMI matched with PCOS women, who will be attending to the clinics of Shahid Beheshti University of Medical Sciences for annual gynecologic examinations. Sample size will be defined as 24 women in each group. Considering the loss of 20% of the subjects, 30 people will be determined for each group. For every individuals, a low energy restricted diet will be designed based on BMI of 22-23 kg/m² and a deficit of 500 kcal per day over 24 weeks. Overnight fasting venous samples will be taken for assessment of glucose, insulin SHBG and testosterone, at 0-12 and 24 weeks. Anthropometric measurements will be taken at 0-12-24 weeks. The effect of restricted energy low GI diet on hirsutism at 0-12-24 weeks and on frequency of menstrual cycles and quality of life at 0-24 weeks will be estimated.
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    هدف این مطالعه مداخله ایی تعیین اثرات رژیم محدود از کالری با نمایه گلایسمیک پایین بر متغیرهای هورمونی و باروری زنان مبتلا به سندرم تخمدان پلی کیستیک و مقایسه اثرات رژیم محدود از کالری بر روی متغیرهای تن سنجی و متابولیک زنان مبتلا و غیر مبتلا می باشد. این مطالعه شامل 30 زن مبتلا و 30 زن غیر مبتلا که از نظر سن و نمایه توده بدن با یکدیگر همسان خواهند شد و از طریق نمونه گیری در دسترس انتخاب خواهند شد، می باشد. افراد گروه مورد از زنان مبتلا به سندرم تخمدان پلی کیستیک مراجعه کننده به مرکز غدد تولید مثل، پژوهشکده علوم غدد درون ریز دانشگاه علوم پزشکی شهید بهشتی خواهند بود. افراد گروه کنترل 30 زن غیر مبتلایی خواهند بود که از نظر سن و نمایه توده بدنی با گروه مورد همسان شده بودند و برای معاینات زنان معمول به درمانگاههای وابسته به دانشگاه علوم پزشکی شهید بهشتی مراجعه خواهند کرد. حجم نمونه 24 نفر در هر گروه بر اورد شد و با در نظر گرفتن 20 درصد ریزش در هر گروه 30 نفر در نظر گرفته شد. برای هریک از افراد شرکت کننده در مطالعه، رژیم انفرادی بر اساس نمایه توده بدن 22-23 کیلوگرم بر متر مربع و کسر 500 کیلوکالری از آن در مدت 6 ماه تنظیم خواهد شد. نمونه خون ناشتا برای بررسی گلوکز، انسولین، پروتئین باند شونده به هورمون جنسی و تستسترون در هفته های 0-12و 24 گرفته خواهد شد. بررسی تن سنجی در هفته های 0-12و 24 انجام خواهد شد.تاثیر رژیم با محدودیت کالری دریافتی بر پرمویی در هفته های 0-12و 24 و بر تعداد سیکل قاعدگی و کیفیت زندگی در هفته صفر و 24 سنجیده خواهد شد.
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    The aims of this interventional study are to examine the effects of energy restricted low glycemic diet on the health-related quality of life questionnaire for women with PCOS (PCOSQ), hirsutism, frequency of menstrual cycles and to compare the effects of energy restricted diet on anthropometric and general Health related quality of life, depression, Rosenberg's Self-Esteem Scale , Body Image Concern Inventory (BICI), female sexual disorder between women with or without PCOS.
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    هدف این مطالعه مداخله ایی تعیین اثرات رژیم محدود از کالری با نمایه گلایسمیک پایین بر کیفیت زندگی اختصاصی زنان مبتلا به سندرم تخمدان پلی کیستیک- پرمویی و تعداد سیکل قاعدگی و مقایسه اثرات رژیم محدود از کالری بر روی متغیرهای تن سنجی- کیفیت زندگی عمومی- افسردگی- مقیاس عزت نفس روزنبرگ- نگرانی از تصویر بدن -اختلال عملکرد جنسی زنان مبتلا و غیر مبتلا می باشد.
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    A clinical trial with parallel groups in 101 women with polycystic ovary syndrome and 101 healthy control who were matched for body mass index and age and were selected by convenience sampling.
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    کار ازمایی بالینی با گروههای موازی در 101 زن مبتلا به سندرم تخمدان پلی کیستیک و 101 زن غیر مبتلا که از نظر سن و نمایه بدن با یکدیگر همسان شده و از طریق نمونه گیری در دسترس انتخاب شدند.
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    The case group will be recruited from PCOS women , attending Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences. Healthy controls recruited from women attending for their annual visit to the health care center affiliated to Shahid Beheshti University of Medical Sciences.
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    گروه مورد از زنان مبتلا به سندرم تخمدان پلی کیستیک مراجعه کننده به مرکز تحقیقات غدد تولید مثل، پژوهشکده علوم غدد، دانشگاه علوم پزشکی شهید بهشتی. انتخاب شدند و افراد گروه کنترل زنان غیر مبتلایی هستند که برای مراقبتهای معمول به درمانگاههای وابسته به دانشگاه علوم پزشکی شهید بهشتی مراجعه داشتند.
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    1-Diagnosis of PCOS according to Rotterdam criteria 2- Age between 18-40 years old 3- BMI > 25 kg / m² and < 38 kg / m² Exclusion criteria 1-Chronic disease 2- Using any hormonal drugs 3-Being pregnant and Lactation 4- Mental disorders
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    معیارهای ورود: 1- تشخیص سندرم تخمدان پلی کیستیک بر اساس معیار رتردام 2-سن بین 18 تا 40 سال 3-نمایه توده بدن بیش از 25 و کمتر یا مساوی 38 کیلوگرم بر متر مربع معیارهای خروج: 1-بیماری مزمن 2-استفاده از هر نوع داروی هورمونی 3- حاملگی و شیردهی 4-اختلالات روانی
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    The intervention includes a restricted energy low glycemic index diet of 500 kcal per day for 6 months to reduce weight by 5 - 10% in women with polycystic ovary syndrome and healthy control.
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    مداخله شامل رژیم غذایی با محدودیت کالری با اندکس گلایسمیک پایین به میزان 500 کیلوکالری در روز در مدت 6 ماه به منظور کاهش وزن 5 تا 10 درصد در زنان مبتلا به سندرم تخمدان پلی کیستیک و زنان غیر مبتلا است.
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    General Health related quality of life, depression, Rosenberg's Self-Esteem Scale , Body Image Concern Inventory (BICI), female sexual disorder, hirsutism, frequency of menstrual cycles, Health-related quality of life questionnaire for women with PCOS (PCOSQ), Anthropometric variables.
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    کیفیت زندگی عمومی; افسردگی; مقیاس عزت نفس روزنبرگ; نگرانی از تصویر بدن ;اختلال عملکرد جنسی; پرمویی; تعداد سیکل قاعدگی; کیفیت زندگی زنان مبتلا به سندرم تخمدان پلی کیستیک; متغیرهای انتروپومتریک
  • General information

    Other
    Supportive
    60
    220
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    Increase the number of samples to examine variables related to quality of life
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    افزایش تعداد نمونه ها برای بررسی متغیرهای مرتبط با کیفیت زندگی
    Diagnosis of PCOS according to Rotterdam criteria
    All participants are Iranian speakers and have the ability to read and write
    Age between 18-40 years old
    BMI > 25 kg / m² and < 38 kg / m²
    تشخیص سندرم تخمدان پلی کیستیک بر اساس معیار رتردام
    تمام شرکت کنندگان فارسی زبان بوده و توانایی خواندن و نوشتن دارند
    سن بین 18 تا 40 سال
    نمایه توده بدن بالاتر از 25 و کمتر از 38 کیلوگرم بر متر مربع
    chronic disease
    Using insulin-sensitizing drugs;
    Using contraceptive drugs
    Using antihypertensive drugs
    Using lipid lowering drugs
    Using any hormonal drugs
    Using any antidepressants
    Special diets or exercise for weight loss in past 6 months
    Participating in previous similar studies
    Ovulation induction in the past year
    Smoking or using alcohol
    Mental disorders
    History of any type of malignancy
    Being pregnant
    Lactation in the past year
    Bleeding of unknown cause
    بیماری مزمن
    استفاده از داروهای حساس کننده انسولین
    استفاده از داروهای ضد بارداری
    استفاده از داروهای ضد فشار خون
    استفاده از داروهای پایین اورنده چربی
    استفاده از هر نوع داروی هورمونی
    استفاده از داروهای ضد افسردگی
    رژیم یا ورزش خاص برای کاهش وزن در 6 ماه گذشته
    شرکت در مطالعات مشابه قبلی
    القای تخمک گذاری در سال قبل
    مصرف سیگار یا الکل
    اختلالات روانی
    سابقه هر نوع بدخیمی
    حاملگی
    شیردهی در سال گذشته
    خونریزی با دلیل ناشناخته
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  • Primary outcomes

    #1
    Free Androgen Index (FAI)
    Quality of Life Score in the Health Short Form Questionnaire (SF-36)
    نمایه آندروژن آزاد
    نمره کیفیت زندگی در پرسشنامه فرم کوتاه بررسی سلامت (SF-36)
    0-12-24 weeks
    0-24 weeks
    هفته های صفر-12-24
    هفته های صفر-24
    (testosterone/SHBG *100)
    The Short Form Health Survey(SF-36)
    از تقسیم تستسترون کل(نانو مول در لیتر) به گلوبولین متصل شونده به هورمون جنسی(نانو مول در لیتر) در صد
    پرسشنامه فرم کوتاه بررسی سلامت (SF-36)
    #2
    Homeostatic model assessment (Insulin resistance)
    Quality of Life Score in Polycystic Ovary Syndrome Questionnaire (PCOSQ)
    ارزیابی مدل هموستاتیک (مقاومت به انسولین)
    نمره کیفیت زندگی در پرسشنامه سندرم تخمدان پلی کیستیک
    0-12-24 weeks
    0--24 weeks
    هفته صفر - 12-24
    هفته صفر - 24
    [fasting insulin (mU/liter)  fasting glucose (mmol/liter)/22.5]
    Polycystic Ovary Syndrome Questionnaire (PCOSQ)
    غلظت انسولين ناشتا ميلي واحد در ليتر) ضرب در ميزان گلوكز ناشتا (ميلي مول در ليتر) تقسيم بر22/5
    پرسشنامه سندرم تخمدان پلی کیستیک
  • Secondary outcomes

    #1
    0-_24 weeks
    0-12-24 weeks
    هفته های صفر -24
    هفته های صفر -12 -24
    #2
    Quality of life
    Depression
    کیفیت زندگی
    افسردگی
    Polycystic Ovary Syndrome Questionnaire (PCOSQ)
    Beck's Depression Inventory
    پرسشنامه اختصاصی کیفیت زندگی زنان مبتلا به سندرم تخمدان پلی کیستیک
    پرسشنامه افسردگی بک
    #3
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    Self-esteem
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    عزت نفس
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    0-24 weeks
    empty
    هفته های صفر - 24
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    Rosenberg Self-esteem Scale (RSES)
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    مقیاس عزت نفس روزنبرگ
    #4
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    ُSexual function
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    عملکرد جنسی
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    Female Sexual Function Index (FSFI)
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    پرسشنامه عملکرد جنسي زنان
    empty
    0-24 weeks
    empty
    هفته های صفر - 24
    #5
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    Body image concern
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    نگرانی تصویر بدن
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    0-24 weeks
    empty
    هفته های صفر - 24
    empty
    Body image concern inventory
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    پرسشنامه نگرانی درباره تصویر بدن
  • Recruitment centers

    #1
    Name of recruitment center - English: Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Behesh
    Name of recruitment center - Persian: مرکز غدد تولید مثل، پژوهشکده علوم غدد درون ریز، دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Farnaz Shishehgar ( PhD in reproductive health)
    Full name of responsible person - Persian: فرناز شیشه گر ، دکتری بهداشت باروری
    Street address - English: 24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
    Street address - Persian: ایران، تهران، خیابان ولنجک، خیابان یمن، خیابان پروانه، پلاک 24
    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: Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Behesh
    Name of recruitment center - Persian: مرکز غدد تولید مثل، پژوهشکده علوم غدد درون ریز، دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Farnaz Shishehgar ( PhD in reproductive health)
    Full name of responsible person - Persian: فرناز شیشه گر، دکتری بهداشت باروری
    Street address - English: NO. 24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
    Street address - Persian: ایران، تهران، خیابان ولنجک، خیابان یمن، خیابان پروانه، پلاک 24
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717413
    Phone: +98 21 2243 2569
    Fax:
    Email: info@endocrine.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Health centers depended to the municipality( velenjak-bime- zaferanieh)
    Name of recruitment center - Persian: مراکز سلامت وابسته به شهرداری ( ولنجک- بیمه - زعفرانیه)
    Full name of responsible person - English: Farnaz Shishehgar ( PhD in reproductive health)
    Full name of responsible person - Persian: فرناز شیشه گر
    Street address - English: 24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
    Street address - Persian: ایران، تهران،خیابان ولنجک، خیابان یمن، خیابان پروانه، پلاک 24
    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: Health centers depended to the municipality( velenjak-bime- zaferanieh)
    Name of recruitment center - Persian: مراکز سلامت وابسته به شهرداری ( ولنجک- بیمه - زعفرانیه)
    Full name of responsible person - English: Farnaz Shishehgar ( PhD in reproductive health)
    Full name of responsible person - Persian: فرناز شیشه گر
    Street address - English: Floor 5, block 1, Islamic Azad University, Science and Research Branch, University Square, Shohada Hesarak Boulevard, Shahid Sattari Highway, Tehran, Iran
    Street address - Persian: تهران بزرگراه شهید ستاری، میدان دانشگاه، بلوار شهدای حصارک، دانشگاه ازاد اسلامی واحد علوم و تحقیقات، بلوک یک، طبقه 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1477893855
    Phone: +98 21 2200 4355
    Fax:
    Email: info@endocrine.ac.ir
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for research of Research Institute for Endocrine Sciences, Shahid Beheshti Universit
    Name of organization / entity - Persian: معاونت پژوهشی پژوهشکده غدد درون ریز دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Doctor Azita Zadeh Vakili
    Full name of responsible person - Persian: دکتر آزیتا زاده وکیلی
    Street address - English: 24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
    Street address - Persian: ایران ، تهران ، ولنجک - خیابان پروانه، پلاک 24
    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 Research Institute for Endocrine Sciences, Shahid Beheshti Universit
    Name of organization / entity - Persian: معاونت پژوهشی پژوهشکده غدد درون ریز دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Doctor Shahram alamdari
    Full name of responsible person - Persian: دکتر شهرام علمداری
    Street address - English: No. 24, Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
    Street address - Persian: ایران ، تهران ، ولنجک ،خیابان پروانه، پلاک 24
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717413
    Phone: +98 21 2243 2500
    Fax:
    Email: info@endocrine.ac.ir
    Web page address:
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    Public
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    Domestic
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    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Behesh
    Name of organization / entity - Persian: مرکز غدد تولید مثل، پژوهشکده علوم غدد درون ریز، دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Fahimeh Ramezani Tehrani
    Full name of responsible person - Persian: فهیمه رمضانی تهرانی
    Position - English: Phd, Gynecologist
    Position - Persian: دکتری، متخصص زنان و زایمان
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 24 Parvaneh, Yaman Street, Velenjak, Tehran, Iran
    Street address - Persian: ایران، تهران، ولنجک ، خیابان پروانه ، پلاک 24
    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 2243 2500
    Mobile:
    Fax:
    Email: ramezani@endocrine.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Farnaz Shishehgar
    Full name of responsible person - Persian: فرناز شیشه گر
    Position - English: Assistant professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: floor 5, block 1, Islamic Azad University, Science and Research Branch, University Square, Shohada Hesarak Boulevard, Shahid Sattari Highway, Tehran, Iran
    Street address - Persian: ایران، تهران، بزرگراه شهید ستاری، میدان دانشگاه، بلوار شهدای حصارک ، دانشگاه ازاد اسلامی واحد علوم و تحقیقات، بلوک یک، طبقه 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1477893855
    Phone: +98 21 2243 2500
    Mobile: +98 910 672 3415
    Fax:
    Email: fshishehgar@iaut.mu.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Behesh
    Name of organization / entity - Persian: مرکز غدد تولید مثل، پژوهشکده علوم غدد درون ریز، دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Farnaz Shishehgar
    Full name of responsible person - Persian: فرناز شیشه گر
    Position - English: Phd, Reproductive Health
    Position - Persian: دکترا - بهداشت باروری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 24 Parvaneh, Yaman Street, Velenjak, Tehran, Iran.
    Street address - Persian: ایران، تهران ، ولنجک ، خیابان پروانه، پلاک 24
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1985717413
    Phone: +98 21 2240 9309
    Mobile: +98 912 159 6693
    Fax:
    Email: shishehgarf@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Farnaz Shishehgar
    Full name of responsible person - Persian: فرناز شیشه گر
    Position - English: Assistant professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: floor 5, block 1, Islamic Azad University, Science and Research Branch, University Square, Shohada Hesarak Boulevard, Shahid Sattari Highway, Tehran, Iran
    Street address - Persian: ایران، بزرگراه شهید ستاری، میدان دانشگاه، بلوار شهدای حصارک ، دانشگاه ازاد اسلامی واحد علوم و تحقیقات، بلوک یک، طبقه 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1985717413
    Phone: +98 21 2240 9309
    Mobile: +98 910 672 3415
    Fax:
    Email: fshishehgar@iaut.mu.ac.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Islamic Azad University , Tehran medical Branch
    Name of organization / entity - Persian: تهران ،دانشگاه ازاد اسلامی واحد علوم پزشکی تهران
    Full name of responsible person - English: farnaz Shishehgar
    Full name of responsible person - Persian: فرناز شبشه گر
    Position - English: PhD -Reproductive Health
    Position - Persian: دکتری، بهداشت باروری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Tehran Medical Branch , Islamic Azad University, khaghani st, shariati Ave , Tehran, Iran
    Street address - Persian: ایران ، تهران ، خیابان شریعتی، خیابان خاقانی، دانشگاه علوم پزشکی آزاد اسلامی واحد تهران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 212226660
    Mobile: +98 15 96693
    Fax:
    Email: shishehgarf@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: farnaz Shishehgar
    Full name of responsible person - Persian: فرناز شبشه گر
    Position - English: Assistant professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: floor 5, block 1, Islamic Azad University, Science and Research Branch, University Square, Shohada Hesarak Boulevard, Shahid Sattari Highway, Tehran, Iran
    Street address - Persian: ایران ، تهران بزرگراه شهید ستاری، میدان دانشگاه، بلوار شهدای حصارک ، دانشگاه ازاد اسلامی واحد علوم و تحقیقات، بلوک یک، طبقه 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1477893855
    Phone: +98 21 2200 4355
    Mobile: +98 910 672 3415
    Fax:
    Email: fshishehgar@iautmu.ac.ir
    Web page address:
  • Sharing plan

    yes
    yes
    yes
    yes
    yes
    undecided
    undecided
    empty
    Main consequences, statistical analysis
    empty
    پیامدهای اصلی، انالیز اماری،
    empty
    The access period will start 6 months after the results are published.
    empty
    شروع دوره دسترسی 6 ماه پس از چاپ نتایج
    empty
    Researchers working in academic and scientific institutions
    empty
    محققین شاغل در موسسات دانشگاهی و علمی
    empty
    Use of statistical tests in the present research in similar studies, Use the main results of current research by citing references to the main authors to compare the results of the current research with the studies of others.
    empty
    استفاده از نحوه انجام انالیز اماری برای انجام در مطالعات مشابه، استفاده از نتایج مطالعه با ذکر ارجاع به نویسندگان اصلی برای مقایسه نتایج مطالعه حاضر با مطالعات دیگران.
    empty
    Email address shishehgarf@yahoo.com
    empty
    ادرس پست الکترونیک
    empty
    6 months after the publication of the current research results, the information requested by the academic persons will be sent to their e-mail.
    empty
    6 ماه بعد از چاپ نتایج مطالعه حاضر، اطلاعات درخواست شده از طرف افراد اکادمیک به ایمیل انها ارسال خواهد شد.

Protocol summary

Study aim
The aims of this interventional study are to examine the effects of energy restricted low glycemic diet on the health-related quality of life questionnaire for women with PCOS (PCOSQ), hirsutism, frequency of menstrual cycles and to compare the effects of energy restricted diet on anthropometric and general Health related quality of life, depression, Rosenberg's Self-Esteem Scale , Body Image Concern Inventory (BICI), female sexual disorder between women with or without PCOS.
Design
A clinical trial with parallel groups in 101 women with polycystic ovary syndrome and 101 healthy control who were matched for body mass index and age and were selected by convenience sampling.
Settings and conduct
The case group will be recruited from PCOS women , attending Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences. Healthy controls recruited from women attending for their annual visit to the health care center affiliated to Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
1-Diagnosis of PCOS according to Rotterdam criteria 2- Age between 18-40 years old 3- BMI > 25 kg / m² and < 38 kg / m² Exclusion criteria 1-Chronic disease 2- Using any hormonal drugs 3-Being pregnant and Lactation 4- Mental disorders
Intervention groups
The intervention includes a restricted energy low glycemic index diet of 500 kcal per day for 6 months to reduce weight by 5 - 10% in women with polycystic ovary syndrome and healthy control.
Main outcome variables
General Health related quality of life, depression, Rosenberg's Self-Esteem Scale , Body Image Concern Inventory (BICI), female sexual disorder, hirsutism, frequency of menstrual cycles, Health-related quality of life questionnaire for women with PCOS (PCOSQ), Anthropometric variables.

General information

Reason for update
Increase the number of samples to examine variables related to quality of life
Acronym
IRCT registration information
IRCT registration number: IRCT2016092129909N1
Registration date: 2016-12-08, 1395/09/18
Registration timing: registered_while_recruiting

Last update: 2022-03-26, 1401/01/06
Update count: 2
Registration date
2016-12-08, 1395/09/18
Registrant information
Name
Farnaz Shishehgar
Name of organization / entity
Reproductive Endocrinology Research Center of Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 4017
Email address
fshishehgar@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-10-18, 1395/07/27
Expected recruitment end date
2017-04-09, 1396/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of interventions based on life style modification in women with polycystic ovarian syndrom
Public title
interventions based on lifestyle modification
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of PCOS according to Rotterdam criteria All participants are Iranian speakers and have the ability to read and write Age between 18-40 years old BMI > 25 kg / m² and < 38 kg / m²
Exclusion criteria:
chronic disease Using insulin-sensitizing drugs; Using contraceptive drugs Using antihypertensive drugs Using lipid lowering drugs Using any hormonal drugs Using any antidepressants Special diets or exercise for weight loss in past 6 months Participating in previous similar studies Ovulation induction in the past year Smoking or using alcohol Mental disorders History of any type of malignancy Being pregnant Lactation in the past year Bleeding of unknown cause
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of research institute for endocrine sciences, Shahid Beheshti University of Medical
Street address
24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
2ERCIES 93/10/23

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E20-E35
ICD-10 code description
Disorders of other endocrine glands

Primary outcomes

1

Description
Quality of Life Score in the Health Short Form Questionnaire (SF-36)
Timepoint
0-24 weeks
Method of measurement
The Short Form Health Survey(SF-36)

2

Description
Quality of Life Score in Polycystic Ovary Syndrome Questionnaire (PCOSQ)
Timepoint
0--24 weeks
Method of measurement
Polycystic Ovary Syndrome Questionnaire (PCOSQ)

Secondary outcomes

1

Description
Hirsutism
Timepoint
0-12-24 weeks
Method of measurement
Ferriman-Gallwey scoring

2

Description
Menstural Cyclicity
Timepoint
0-12-24 weeks
Method of measurement
Questionnare

3

Description
Waist Circumference
Timepoint
0-12-24 weeks
Method of measurement
non flexible tape measure

4

Description
Hip circumference
Timepoint
0-12-24 weeks
Method of measurement
non flexible tape measure

5

Description
Weight
Timepoint
0-12-24 weeks
Method of measurement
digital scale

6

Description
Depression
Timepoint
0-24 weeks
Method of measurement
Beck's Depression Inventory

7

Description
Self-esteem
Timepoint
0-24 weeks
Method of measurement
Rosenberg Self-esteem Scale (RSES)

8

Description
ُSexual function
Timepoint
Female Sexual Function Index (FSFI)
Method of measurement
0-24 weeks

9

Description
Body image concern
Timepoint
0-24 weeks
Method of measurement
Body image concern inventory

Intervention groups

1

Description
energy restricted low glycemic اindex diet
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Behesh
Full name of responsible person
Farnaz Shishehgar ( PhD in reproductive health)
Street address
NO. 24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2569
Email
info@endocrine.ac.ir

2

Recruitment center
Name of recruitment center
Health centers depended to the municipality( velenjak-bime- zaferanieh)
Full name of responsible person
Farnaz Shishehgar ( PhD in reproductive health)
Street address
Floor 5, block 1, Islamic Azad University, Science and Research Branch, University Square, Shohada Hesarak Boulevard, Shahid Sattari Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 2200 4355
Email
info@endocrine.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Research Institute for Endocrine Sciences, Shahid Beheshti Universit
Full name of responsible person
Doctor Shahram alamdari
Street address
No. 24, Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
info@endocrine.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Research Institute for Endocrine Sciences, Shahid Beheshti Universit
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
Islamic Azad University
Full name of responsible person
Farnaz Shishehgar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
floor 5, block 1, Islamic Azad University, Science and Research Branch, University Square, Shohada Hesarak Boulevard, Shahid Sattari Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 2243 2500
Fax
Email
fshishehgar@iaut.mu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farnaz Shishehgar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
floor 5, block 1, Islamic Azad University, Science and Research Branch, University Square, Shohada Hesarak Boulevard, Shahid Sattari Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2240 9309
Fax
Email
fshishehgar@iaut.mu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
farnaz Shishehgar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
floor 5, block 1, Islamic Azad University, Science and Research Branch, University Square, Shohada Hesarak Boulevard, Shahid Sattari Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 2200 4355
Fax
Email
fshishehgar@iautmu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Main consequences, statistical analysis
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of statistical tests in the present research in similar studies, Use the main results of current research by citing references to the main authors to compare the results of the current research with the studies of others.
From where data/document is obtainable
Email address shishehgarf@yahoo.com
What processes are involved for a request to access data/document
6 months after the publication of the current research results, the information requested by the academic persons will be sent to their e-mail.
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