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Protocol summary
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.
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 and anexiety, Rosenberg's Self-Esteem Scale , Body Image, Binge eating scale, female sexual disorder between women with or without PCOS.
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 and anexiety, Rosenberg's Self-Esteem Scale , Body Image Concern Inventory (BICI), Binge eating scale, female sexual disorder between women with or without PCOS.
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.
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 و اضطراب- مقیاس عزت نفس روزنبرگ- تصویر بدن - مقیاس پرخوری-اختلال عملکرد جنسی زنان مبتلا و غیر مبتلا می باشد.
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 و اضطراب- مقیاس عزت نفس روزنبرگ- نگرانی از تصویر بدن - مقیاس پرخوری-اختلال عملکرد جنسی زنان مبتلا و غیر مبتلا می باشد.
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 Health related quality of life, depression, Rosenberg's Self-Esteem Scale , Body Image, Binge eating scale, female sexual disorder, hirsutism, frequency of menstrual cycles, Health-related quality of life questionnaire for women with PCOS (PCOSQ), Anthropometric variables.
General Health related quality of life, depression, Rosenberg's Self-Esteem Scale , Body Image Concern Inventory (BICI), Binge eating scale, female sexual disorder, hirsutism, frequency of menstrual cycles, Health-related quality of life questionnaire for women with PCOS (PCOSQ), Anthropometric variables.
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
کیفیت زندگی عمومی; افسردگی; مقیاس عزت نفس روزنبرگ; تصویر بدن ، مقیاس پرخوری;اختلال عملکرد جنسی; پرمویی; تعداد سیکل قاعدگی; کیفیت زندگی زنان مبتلا به سندرم تخمدان پلی کیستیک; متغیرهای انتروپومتریک
کیفیت زندگی عمومی; افسردگی; مقیاس عزت نفس روزنبرگ; نگرانی از تصویر بدن ، مقیاس پرخوری;اختلال عملکرد جنسی; پرمویی; تعداد سیکل قاعدگی; کیفیت زندگی زنان مبتلا به سندرم تخمدان پلی کیستیک; متغیرهای انتروپومتریک
General information
2016-10-18, 1395/07/27
2019-01-04, 1397/10/14
20162019-1001-1804 00:00:00
2017-04-09, 1396/01/20
2020-02-16, 1398/11/27
20172020-0402-0916 00:00:00
Increase the number of samples to examine variables related to quality of life
Due to executive problems, the start of sampling was postponed and ethical approval was acquired from the ethics committee of the Research Institute of Endocrine Sciences.
IncreaseDue to executive problems, the numberstart of samples to examine variables related to qualitysampling was postponed and ethical approval was acquired from the ethics committee of lifethe Research Institute of Endocrine Sciences.
افزایش تعداد نمونه ها برای بررسی متغیرهای مرتبط با کیفیت زندگی
بدلیل مشکلات اجرایی، شروع نمونه گیری به تعویق افتاد و تاییدیه اخلاقی از کمیته اخلاق پژوهشکده علوم غدد اخذ شد.
افزایش تعدادبدلیل مشکلات اجرایی، شروع نمونه ها برای بررسی متغیرهای مرتبط با کیفیت زندگیگیری به تعویق افتاد و تاییدیه اخلاقی از کمیته اخلاق پژوهشکده علوم غدد اخذ شد.
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:
Name of organization / entity - English:
Name of organization / entity - Persian:
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: 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:
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:
ندارد
ندارد
not applicable
not applicable
ندارد
ندارد
Vice Chancellor for research of Research Institute for Endocrine Sciences, Shahid Beheshti Universit
Shahid Beheshti University of Medical Sciences
Vice Chancellor for research of Research Institute for Endocrine Sciences, Shahid Beheshti UniversitUniversity of Medical Sciences
معاونت پژوهشی پژوهشکده غدد درون ریز دانشگاه علوم پزشکی شهید بهشتی
دانشگاه علوم پزشکی شهید بهشتی
معاونت پژوهشی پژوهشکده غدد درون ریز دانشگاه علوم پزشکی شهید بهشتی
Person responsible for general inquiries
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:
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: +98 912 159 6693
Fax:
Email: fshishehgar@iaut.mu.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 3415912 159 6693 Fax: Email: fshishehgar@iaut.mu.ac.ir Web page address:
Person responsible for scientific inquiries
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:
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: +98 912 159 6693
Fax:
Email: fshishehgar@iaut.mu.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، 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 3415912 159 6693 Fax: Email: fshishehgar@iaut.mu.ac.ir Web page address:
Person responsible for updating data
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:
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: +98 912 159 6693
Fax:
Email: fshishehgar@iautmu.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 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 3415912 159 6693 Fax: Email: fshishehgar@iautmu.ac.ir Web page address:
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 and anexiety, Rosenberg's Self-Esteem Scale , Body Image, Binge eating scale, 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, Binge eating scale, 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
Due to executive problems, the start of sampling was postponed and ethical approval was acquired from the ethics committee of the Research Institute of Endocrine Sciences.
Acronym
IRCT registration information
IRCT registration number:IRCT2016092129909N1
Registration date:2016-12-08, 1395/09/18
Registration timing:prospective
Last update:2023-06-13, 1402/03/23
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
2019-01-04, 1397/10/14
Expected recruitment end date
2020-02-16, 1398/11/27
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 Universityof Medical
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
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.