Comparison of the efficacy of herbal medicine (Mixture) with Clomiphene citrate in treatment of Poly-cystic ovary syndrome (PCOS) and fertility rate in infertile women referring toTabriz Al-Zahra hospital.
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Protocol summary
The aim of study is to evaluate the effects of herbal medicine (Mixture) on Polycystic ovary syndrome (PCOS) in infertile women. herbal medicine (Mixture) is a 700 mg capsule containing 250 mg Mentha longifolia, 200 mg Zingiber officinale, 150 mg Cinnamon and 100 mg Citrus that is standardized by Part Teb International Company. 102 patients diagnosed with PCOS and infertility and aged 20-35 after obtaining inform consent will be randomly selected and assigned to 3 groups; 34 people in each. Random assignment of individuals to each group would allow confounding factors to be well controlled. In case of drug intolerance or dissatisfaction in any stage of the study, they are free to withdraw any time. The first group (intervention) will be given herbal medicine (Mixture) with a dose of 700mgs/day continuous for 3 months, the second group (control) will receive routine treatment of Clomiphene Citrate 50-150 mg for 3 menstrual cycles, starting from 5th day of menstruation for 5 days and the third group (intervention) will receive both herbal medicine (Mixture) and routine treatment as mentioned above. Before intervention and three months after the completion of medication patients in all three groups will be evaluated by blood tests of sex hormones (FSH, LH, estradiol, testosterone), biochemical markers (glucose, cholesterol, triglycerides, insulin), antioxidants levels (catalase, glutathione peroxidase, superoxide peroxidase, malondialdehyde) and Sonographic criteria of the ovary (ovarian size, number and size of follicles). This study is not blinded. In this study, improvement of ovarian cysts is considered as the primary outcome and pregnancy as secondary outcome.
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The aim of study is to evaluate the effects of herbal medicine (Mixture) on Polycystic ovary syndrome (PCOS) in infertile women. herbal medicine (Mixture) is a 700 mg capsule containing 250 mg Mentha longifolia, 200 mg Zingiber officinale, 150 mg Cinnamon and 100 mg Citrus that is standardized by Part Teb International Company. 102 patients diagnosed with PCOS and infertility and aged 20-35 after obtaining inform consent will be randomly selected and assigned to 3 groups; 34 people in each. Random assignment of individuals to each group would allow confounding factors to be well controlled. In case of drug intolerance or dissatisfaction in any stage of the study, they are free to withdraw any time. The first group (intervention) will be given herbal medicine (Mixture) with a dose of 700mgs/day continuous for 3 months, the second group (control) will receive routine treatment of Clomiphene Citrate 50-150 mg for 3 menstrual cycles, starting from 5th day of menstruation for 5 days and the third group (intervention) will receive both herbal medicine (Mixture) and routine treatment as mentioned above. Before intervention and three months after the completion of medication patients in all three groups will be evaluated by blood tests of sex hormones (FSH, LH, estradiol, testosterone), biochemical markers (glucose, cholesterol, triglycerides, insulin), antioxidants levels (catalase, glutathione peroxidase, superoxide peroxidase, malondialdehyde) and Sonographic criteria of the ovary (ovarian size, number and size of follicles). This study is not blinded. In this study, improvement of ovarian cysts is considered as the primary outcome and pregnancy as secondary outcome.
هدف از این مطالعه بررسی تأثیر مخلوط چند گیاه دارویی بر درمان سندرم تخمدان پلي كيستيك (PCOS) در زنان نابارور می باشد. مخلوط چند گیاه دارویی بصورت کپسول mg700 که شامل mg250 پونه+ mg200 زنجبیل+ mg 150دارچین و mg 100 پوست پرتقال می باشد که توسط شرکت بین المللی پارت طب ارس (دانش بنیان) استانداد سازی شده است. گروه مورد مطالعه 102 زن نابارور با تشخیص PCOS و در سن 20-35 که بعد از گرفتن رضایتنامه ی آگاهانه بصورت تصادفی در 3 گروه 34 نفره تقسیم شدند. انتساب تصادفی افراد به گروهها باعث خواهد شد عوامل مخدوشگر تا حدودی کنترل شود. در صورت عدم تحمل دارو یا عدم رضایت در هر مرحله با اختیار تمام افراد می توانند از مطالعه خارج شوند. گروه اول درمان (مداخله) مخلوط چند گیاه دارویی با دوزmg 700 روزانه یک عدد مداوم بمدت 3 ماه دریافت خواهد کرد، گروه دوم درمان (کنترل) دریافت درمان روتین قرص کلومیفن سیتراتmg 50-150 بمدت 3 سیکل قاعدگی که از روز پنجم سیکل قاعدگی بمدت 5 روز دریافت خواهد کرد و گروه سوم درمان (مداخله) مخلوط چند گیاه دارویی به همراه درمان روتین به شرح فوق را دریافت خواهد کرد. افراد مورد مطالعه، قبل از مداخله و سه ماه بعد از تکمیل دوره درمان میزان سطح خونی هورمون های جنسی (FSH، LH ،استرادیول، تستوسترون)، میزان سطح خونی مارکرهای بیوشیمیایی (قند خون، کلسترول، تری گلیسرید، انسولین)، میزان سطح آنتی اکسیدانتهای خون (کاتالاز، گلوتاتیون پراکسیداز، سوپر اکسید پراکسیداز، مالوندی آلدئید)و معیارهای سونوگرافیک تخمدان (سایز تخمدان، تعدد و اندازه ی فولیکولها) ارزیابی خواهد شد. این مطالعه کور نشده است. در این مطالعه، درمان کیست های تخمدانی بعنوان پیامد اول و حصول باروری بعنوان پیامد دوم در نظر گرفته شده است.
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هدف از این مطالعه بررسی تأثیر مخلوط چند گیاه دارویی بر درمان سندرم تخمدان پلي كيستيك (PCOS) در زنان نابارور می باشد. مخلوط چند گیاه دارویی بصورت کپسول mg700 که شامل mg250 پونه+ mg200 زنجبیل+ mg 150دارچین و mg 100 پوست پرتقال می باشد که توسط شرکت بین المللی پارت طب ارس (دانش بنیان) استانداد سازی شده است. گروه مورد مطالعه 102 زن نابارور با تشخیص PCOS و در سن 20-35 که بعد از گرفتن رضایتنامه ی آگاهانه بصورت تصادفی در 3 گروه 34 نفره تقسیم شدند. انتساب تصادفی افراد به گروهها باعث خواهد شد عوامل مخدوشگر تا حدودی کنترل شود. در صورت عدم تحمل دارو یا عدم رضایت در هر مرحله با اختیار تمام افراد می توانند از مطالعه خارج شوند. گروه اول درمان (مداخله) مخلوط چند گیاه دارویی با دوزmg 700 روزانه یک عدد مداوم بمدت 3 ماه دریافت خواهد کرد، گروه دوم درمان (کنترل) دریافت درمان روتین قرص کلومیفن سیتراتmg 50-150 بمدت 3 سیکل قاعدگی که از روز پنجم سیکل قاعدگی بمدت 5 روز دریافت خواهد کرد و گروه سوم درمان (مداخله) مخلوط چند گیاه دارویی به همراه درمان روتین به شرح فوق را دریافت خواهد کرد. افراد مورد مطالعه، قبل از مداخله و سه ماه بعد از تکمیل دوره درمان میزان سطح خونی هورمون های جنسی (FSH، LH ،استرادیول، تستوسترون)، میزان سطح خونی مارکرهای بیوشیمیایی (قند خون، کلسترول، تری گلیسرید، انسولین)، میزان سطح آنتی اکسیدانتهای خون (کاتالاز، گلوتاتیون پراکسیداز، سوپر اکسید پراکسیداز، مالوندی آلدئید)و معیارهای سونوگرافیک تخمدان (سایز تخمدان، تعدد و اندازه ی فولیکولها) ارزیابی خواهد شد. این مطالعه کور نشده است. در این مطالعه، درمان کیست های تخمدانی بعنوان پیامد اول و حصول باروری بعنوان پیامد دوم در نظر گرفته شده است.
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evaluate the effects of herbal Mixture in infertile women with Polycystic ovary syndrome (PCOS).
evaluate the effects of herbal Mixture in infertile women with Polycystic ovary syndrome (PCOS).
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بررسی تأثیر مخلوط چند گیاه دارویی بر درمان سندرم تخمدان پلي كيستيك در زنان نابارور می باشد.
بررسی تأثیر مخلوط چند گیاه دارویی بر درمان سندرم تخمدان پلي كيستيك در زنان نابارور می باشد.
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This single-blind randomized clinical trial the participants were divided into three groups (g1: Clomiphene Citrate (CC); g2: herbal mixture; and g3: herbal mixture along with (CC) by random allocation software through randomized blocks of three and six with an allocation ratio of 1:1:1. For allocation concealment, according to sequence generation opaque and sealed envelopes No; each contain a letter designating the allocation. The 1envelope was dedicated to 1 participant and this process was followed to the end of the research.ample size was calculated based on three variables of MDA, Testosterone and HOMA-IR.
This single-blind randomized clinical trial the participants were divided into three groups (g1: Clomiphene Citrate (CC); g2: herbal mixture; and g3: herbal mixture along with (CC) by random allocation software through randomized blocks of three and six with an allocation ratio of 1:1:1. For allocation concealment, according to sequence generation opaque and sealed envelopes No; each contain a letter designating the allocation. The 1envelope was dedicated to 1 participant and this process was followed to the end of the research.ample size was calculated based on three variables of MDA, Testosterone and HOMA-IR.
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در این کارآزمایی بالینی تصادفی کنترل شده تك سو كور زنان مورد مطالعه در سه گروه بطور تصادفی و با استفاده از جدول اعداد تصادفی كامپيوتري به سه گروه (گروه 1: كلوميفن سيترات، گروه 2: تركيب گياهي و گروه 3: كلوميفن سيترات همراه با تركيب گياهي) با نسبت تخصيص 1:1:1 تقسيم شدند. براي پنهان سازي تخصيص، نوع مداخله داخل پاكت هاي هم شکل قرار داده شده و پشت سرهم شماره گذاري شده و مهر و موم شد. از شروع نمونه گيري اولين پاكت به اولين فرد داراي معيارهاي ورود به مطالعه داده شد و به همين منوال تا تکمیل شدن حجم نمونه تا پایان مطالعه ادامه یافت.حجم نمونه بر اساس هر سه متغیر مالوندی آلدئید، تستوسترون و HOMA-IR محاسبه شد.
در این کارآزمایی بالینی تصادفی کنترل شده تك سو كور زنان مورد مطالعه در سه گروه بطور تصادفی و با استفاده از جدول اعداد تصادفی كامپيوتري به سه گروه (گروه 1: كلوميفن سيترات، گروه 2: تركيب گياهي و گروه 3: كلوميفن سيترات همراه با تركيب گياهي) با نسبت تخصيص 1:1:1 تقسيم شدند. براي پنهان سازي تخصيص، نوع مداخله داخل پاكت هاي هم شکل قرار داده شده و پشت سرهم شماره گذاري شده و مهر و موم شد. از شروع نمونه گيري اولين پاكت به اولين فرد داراي معيارهاي ورود به مطالعه داده شد و به همين منوال تا تکمیل شدن حجم نمونه تا پایان مطالعه ادامه یافت.حجم نمونه بر اساس هر سه متغیر مالوندی آلدئید، تستوسترون و HOMA-IR محاسبه شد.
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it was done in alzahra hospital ,TBZMED. All participants were informed about the purpose of the study, and an informed consent was obtained from each of them.
it was done in alzahra hospital ,TBZMED. All participants were informed about the purpose of the study, and an informed consent was obtained from each of them.
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در بخش نازایی بیمارستان الزهرا- دانشگاه علوم پزشکی تبریز انجام شد. پس از بيان اهداف مطالعه، عوارض جانبی احتمالی و مزاياي شركت در مطالعه با یاد آوری داوطلبانه بودن شركت در تحقيق و تکميل فرم رضایت آگاهانه جهت شركت در مطالعه دعوت به همکاري شدند.
در بخش نازایی بیمارستان الزهرا- دانشگاه علوم پزشکی تبریز انجام شد. پس از بيان اهداف مطالعه، عوارض جانبی احتمالی و مزاياي شركت در مطالعه با یاد آوری داوطلبانه بودن شركت در تحقيق و تکميل فرم رضایت آگاهانه جهت شركت در مطالعه دعوت به همکاري شدند.
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Inclusion: willing to participate in the study, having at least two out of three of the Rotterdam criteria (2003) for the diagnosis of PCOS, aged between 18–35 years old, having BMI less than 30, not receiving any treatment at least in the last 3 months.Exclusion: diabetes mellitus, use of medications such as those helping ovulation or insulin sensitizers, thyroid disorders, cholesterol-lowering drugs, smoking, Hypertension, cardiovascular diseases, Cushing syndrome, allergy to Mentha spicata , Zingiber officinale , Cinnamomum zeylanicum and Citrus Sinensis
Inclusion: willing to participate in the study, having at least two out of three of the Rotterdam criteria (2003) for the diagnosis of PCOS, aged between 18–35 years old, having BMI less than 30, not receiving any treatment at least in the last 3 months.Exclusion: diabetes mellitus, use of medications such as those helping ovulation or insulin sensitizers, thyroid disorders, cholesterol-lowering drugs, smoking, Hypertension, cardiovascular diseases, Cushing syndrome, allergy to Mentha spicata , Zingiber officinale , Cinnamomum zeylanicum and Citrus Sinensis
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ورود: تمایل به شركت در مطالعه، داشتن 2 تا از 3 معيار روتردام (2003) براي تشخیص PCOS، سن بین 18-35 سال، BMI کمتر از 30، حداقل تا 3 ماه قبل هيچ درمانی دریافت نکرده باشد.
خروج: مبتلا به دیابت، استفاده از هر داروی تحریک کننده تخمدان یا افزایش حساسیت به انسولین، بیماری تیروئید، داروهای کاهش دهنده ی چربی خون، سیگاری بودن، فشار خون بالا،بیماری قلبی ، سندرم کوشینگ، حساسیت به نعناع دشتی، زنجبیل، دارچین و پوست پرتقال
ورود: تمایل به شركت در مطالعه، داشتن 2 تا از 3 معيار روتردام (2003) براي تشخیص PCOS، سن بین 18-35 سال، BMI کمتر از 30، حداقل تا 3 ماه قبل هيچ درمانی دریافت نکرده باشد. خروج: مبتلا به دیابت، استفاده از هر داروی تحریک کننده تخمدان یا افزایش حساسیت به انسولین، بیماری تیروئید، داروهای کاهش دهنده ی چربی خون، سیگاری بودن، فشار خون بالا،بیماری قلبی ، سندرم کوشینگ، حساسیت به نعناع دشتی، زنجبیل، دارچین و پوست پرتقال
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clomiphene citrate group from third- fifth day of menstruation for five days for three menstrual cycles; herbal mixture capsule group, herbal mixture capsule group along with CC for 3 months
clomiphene citrate group from third- fifth day of menstruation for five days for three menstrual cycles; herbal mixture capsule group, herbal mixture capsule group along with CC for 3 months
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گروه كلوميفن سيترات ، گروه كپسول تركيب گياهي T گروه قرص كلوميفن سيترات همراه با كپسول تركيب گیاهی طبق دستور مصرف گروههاي قبل به مدت 3 ماه از روز 3 الی 5 قاعدگی
گروه كلوميفن سيترات ، گروه كپسول تركيب گياهي T گروه قرص كلوميفن سيترات همراه با كپسول تركيب گیاهی طبق دستور مصرف گروههاي قبل به مدت 3 ماه از روز 3 الی 5 قاعدگی
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Primary outcomes included serum levels of antioxidants blood biomarkers and sex hormones.Thyroid hormones and clinical features were considered as secondary outcomes.
Primary outcomes included serum levels of antioxidants blood biomarkers and sex hormones.Thyroid hormones and clinical features were considered as secondary outcomes.
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پيامد هاي اوليه شامل ميانگين سطوح سرمی شاخص هاي مرتبط با استرس اكسيداتيو بيوماركرهاي خون و هورمون های جنسی بود. ميانگين سطح سرمی هورمون هاي تيروئيد و شاخص هاي باليني به عنوان پيامدهاي ثانویه لحاظ شدند.
پيامد هاي اوليه شامل ميانگين سطوح سرمی شاخص هاي مرتبط با استرس اكسيداتيو بيوماركرهاي خون و هورمون های جنسی بود. ميانگين سطح سرمی هورمون هاي تيروئيد و شاخص هاي باليني به عنوان پيامدهاي ثانویه لحاظ شدند.
General information
20
18
2018
Not blinded
Single blinded
notblsingl
1
1
No
No
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It was requested that some sections that were incomplete be completed.
It was requested that some sections that were incomplete be completed.
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درخواست شده بود که بعضی بخش ها که ناقص هستند کامل شوند.
درخواست شده بود که بعضی بخش ها که ناقص هستند کامل شوند.
Evaluation of the effects of herbal medicine (Mixture) on Polycystic ovary syndrome (PCOS) in infertile women.
The effects of herbal mixture in infertile women with Polycystic ovary syndrome (PCOS): a randomized controlled trial
Evaluation of theThe effects of herbal medicine (Mixture) onmixture in infertile women with Polycystic ovary syndrome (PCOS) in infertile women.: a randomized controlled trial
بررسی تأثیر مخلوط چند گیاه دارویی بر درمان سندرم تخمدان پلي كيستيك (PCOS) در زنان نابارور
بررسی تأثیر مخلوط چند گیاه دارویی بر درمان سندرم تخمدان پلي كيستيك (PCOS) در زنان نابارور: کارآزمایی بالینی تصادفی کنترل شده
بررسی تأثیر مخلوط چند گیاه دارویی بر درمان سندرم تخمدان پلي كيستيك (PCOS) در زنان نابارور: کارآزمایی بالینی تصادفی کنترل شده
willing to participate in the study
having at least two out of three of the Rotterdam criteria (2003) for the diagnosis of PCOS
aged between 18–35 years old
having body mass index (BMI) less than 30
not receiving any treatment at least in the last 3 months (wash out)
willing to participate in the study having at least two out of three of the Rotterdam criteria (2003) for the diagnosis of PCOS aged between 18–35 years old having body mass index (BMI) less than 30 not receiving any treatment at least in the last 3 months (wash out)
تمایل به شركت در مطالعه
داشتن 2 تا از 3 معيار روتردام (2003) براي تشخیص PCOS
سن بین 18-35 سال
داشتن BMI کمتر از 30
حداقل تا 3 ماه قبل هيچ درمانی دریافت نکرده باشد (تا wash out صورت گیرد)
تمایل به شركت در مطالعه داشتن 2 تا از 3 معيار روتردام (2003) براي تشخیص PCOS سن بین 18-35 سال داشتن BMI کمتر از 30 حداقل تا 3 ماه قبل هيچ درمانی دریافت نکرده باشد (تا wash out صورت گیرد)
patients with diabetes mellitus
use of medications such as those helping ovulation or insulin sensitizers
thyroid disorders
cholesterol-lowering drugs
smoking
hypertension
cardiovascular diseases
Cushing syndrome
allergy to Mentha spicata (spearmint), Zingiber officinale (ginger) ,Cinnamomum zeylanicum (cinnamon), and Citrus Sinensis (sweet orange)
patients with diabetes mellitus use of medications such as those helping ovulation or insulin sensitizers thyroid disorders cholesterol-lowering drugs smoking hypertension cardiovascular diseases Cushing syndrome allergy to Mentha spicata (spearmint), Zingiber officinale (ginger) ,Cinnamomum zeylanicum (cinnamon), and Citrus Sinensis (sweet orange)
بیماران مبتلا به دیابت
استفاده از هر داروی تحریک کننده تخمدان یا افزایش حساسیت به انسولین
بیماری تیروئید
داروهای کاهش دهنده ی چربی خون
سیگاری بودن
فشار خون بالا
بیماریهای قلبی -عروقی
سندرم کوشینگ
حساسیت به نعناء دشتی، زنجبیل، دارچین و پوست پرتقال
بیماران مبتلا به دیابت استفاده از هر داروی تحریک کننده تخمدان یا افزایش حساسیت به انسولین بیماری تیروئید داروهای کاهش دهنده ی چربی خون سیگاری بودن فشار خون بالا بیماریهای قلبی -عروقی سندرم کوشینگ حساسیت به نعناء دشتی، زنجبیل، دارچین و پوست پرتقال
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The participants were divided into three groups (group 1: Clomiphene Citrate (CC); group 2: herbal mixture; and group 3: herbal mixture along with (CC) by random allocation software through randomized blocks of three and six with an allocation ratio of 1:1:1. For allocation concealment, according to sequence generation opaque and sealed envelopes numbered; each contain a letter designating the allocation. The first envelope was dedicated to first participant and this process was followed to the end of the research.Only the statistician was blind to the study.
The participants were divided into three groups (group 1: Clomiphene Citrate (CC); group 2: herbal mixture; and group 3: herbal mixture along with (CC) by random allocation software through randomized blocks of three and six with an allocation ratio of 1:1:1. For allocation concealment, according to sequence generation opaque and sealed envelopes numbered; each contain a letter designating the allocation. The first envelope was dedicated to first participant and this process was followed to the end of the research.Only the statistician was blind to the study.
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زنان مورد مطالعه در سه گروه بطور تصادفی و با استفاده از جدول اعداد تصادفی كامپيوتري به سه گروه (گروه 1: كلوميفن سيترات، گروه 2: تركيب گياهي و گروه 3: كلوميفن سيترات همراه با تركيب گياهي) با نسبت تخصيص 1:1:1 تقسيم شدند. براي پنهان سازي تخصيص، نوع مداخله داخل پاكت هاي هم شکل قرار داده شده و پشت سرهم شماره گذاري شده و مهر و موم شد. از شروع نمونه گيري اولين پاكت به اولين فرد داراي معيارهاي ورود به مطالعه داده شد و به همين منوال تا تکمیل شدن حجم نمونه تا پایان مطالعه ادامه یافت. شایان ذكر است كه نتایج آزمایش از دید آناليزور پنهان ماند.
زنان مورد مطالعه در سه گروه بطور تصادفی و با استفاده از جدول اعداد تصادفی كامپيوتري به سه گروه (گروه 1: كلوميفن سيترات، گروه 2: تركيب گياهي و گروه 3: كلوميفن سيترات همراه با تركيب گياهي) با نسبت تخصيص 1:1:1 تقسيم شدند. براي پنهان سازي تخصيص، نوع مداخله داخل پاكت هاي هم شکل قرار داده شده و پشت سرهم شماره گذاري شده و مهر و موم شد. از شروع نمونه گيري اولين پاكت به اولين فرد داراي معيارهاي ورود به مطالعه داده شد و به همين منوال تا تکمیل شدن حجم نمونه تا پایان مطالعه ادامه یافت. شایان ذكر است كه نتایج آزمایش از دید آناليزور پنهان ماند.
empty
The statistician was blind to the study.
The statistician was blind to the study.
empty
نتایج آزمایش از دید آناليزور پنهان ماند.
نتایج آزمایش از دید آناليزور پنهان ماند.
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empty
Recruitment centers
#1
Name of recruitment center - English: Infertility Center Of Alzahra Hospital
Name of recruitment center - Persian: کلینیک ناباروری بیمارستان الزهرا
Full name of responsible person - English: Dr.Elaheh Ouladsahebmadarek
Full name of responsible person - Persian: دکتر الهه اولاد صاحب مدارک
Street address - English: Alzahra Hospital, South Artesh Ave
Street address - Persian: ارتش جنوبی، مرکز آموزشی درمانی الزهرا
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Arash Khaki
Name of recruitment center - Persian: Arash Khaki
Full name of responsible person - English: Arash Khaki
Full name of responsible person - Persian: Arash Khaki
Street address - English: South shareati Street
Street address - Persian: ارتش جنوبی، مرکز آموزشی درمانی الزهرا
City - English: Tabriz
City - Persian: Tabriz
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5138815941
Phone: +98 51 3554 1221
Fax:
Email: arashkhaki@yahoo.com
Web page address: https://wrhrc-en.tbzmed.ac.ir/
Name of recruitment center - English: Infertility Center Of Alzahra HospitalArash Khaki Name of recruitment center - Persian: کلینیک ناباروری بیمارستان الزهراArash Khaki Full name of responsible person - English: Dr.Elaheh OuladsahebmadarekArash Khaki Full name of responsible person - Persian: دکتر الهه اولاد صاحب مدارکArash Khaki Street address - English: Alzahra Hospital, South Artesh Aveshareati Street Street address - Persian: ارتش جنوبی، مرکز آموزشی درمانی الزهرا City - English: Tabriz City - Persian: تبریزTabriz Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5138815941 Phone: +98 51 3554 1221 Fax: Email: arashkhaki@yahoo.com Web page address: https://wrhrc-en.tbzmed.ac.ir/
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for Research,Tabriz University Of Medical Sciences
Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr.Alireza Rashidi
Full name of responsible person - Persian: دکتر علیرضا رشیدی
Street address - English: Third Floor, Central Building of Number2, Golgasht Street
Street address - Persian: خیابان گلگشت، ساختمان مرکزی شماره دو، طبقه سوم
City - English: Tabriz
City - Persian: تبریز
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,Tabriz University Of Medical Sciences
Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr.Alireza Rashidi
Full name of responsible person - Persian: دکتر علیرضا رشیدی
Street address - English: Third Floor, Central Building of Number2, Golgasht Street
Street address - Persian: خیابان گلگشت، ساختمان مرکزی شماره دو، طبقه سوم
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 3554 1221
Fax:
Email: wrhrcenter@gmail.com
Web page address: https://wrhrc-en.tbzmed.ac.ir/
contact.organization_id: Name of organization / entity - English: Vice chancellor for Research,Tabriz University Of Medical Sciences Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr.Alireza Rashidi Full name of responsible person - Persian: دکتر علیرضا رشیدی Street address - English: Third Floor, Central Building of Number2, Golgasht Street Street address - Persian: خیابان گلگشت، ساختمان مرکزی شماره دو، طبقه سوم City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5138665793 Phone: +98 41 3554 1221 Fax: Email: wrhrcenter@gmail.com Web page address: https://wrhrc-en.tbzmed.ac.ir/
empty
Private
private
empty
Domestic
domestic
empty
Other
other
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Woman's Reproductive Health Research Center
Name of organization / entity - Persian: مرکز تحقیقات سلامت و باروری زنان
Full name of responsible person - English: Dr.arash khaki
Full name of responsible person - Persian: دکتر آرش خاکی
Position - English: Prof. of Pathology
Position - Persian: استاد پاتولوژی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Alzahra Hospital, South Artesh Ave
Street address - Persian: ارتش جنوبی چهار راه باغشمال
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3556 9543
Mobile: +98 914 313 8399
Fax:
Email: arashkaki@yahoo.com; wrhrcenter@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: PMC Pharmaceutical International Company
Name of organization / entity - Persian: شرکت داروسازی بین المللی پارت طب ارس
Full name of responsible person - English: Arash Khaki
Full name of responsible person - Persian: آرش خاکی
Position - English: Prof. of Pathology
Position - Persian: استاد پاتولوژی
Latest degree: phd
Area of specialty/work: 26
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: South shareati Street
Street address - Persian: شریعتی جنوبی
City - English: Tabriz
City - Persian: Tabriz
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138815941
Phone: +98 41 3555 6943
Mobile: +98 914 313 8399
Fax:
Email: arashkhaki@yahoo.com
Web page address: https://pmcpharma.org
contact.organization_id: Name of organization / entity - English: Woman's Reproductive Health Research CenterPMC Pharmaceutical International Company Name of organization / entity - Persian: مرکز تحقیقات سلامت و باروری زنانشرکت داروسازی بین المللی پارت طب ارس Full name of responsible person - English: Dr.arash khakiArash Khaki Full name of responsible person - Persian: دکتر آرش خاکی Position - English: Prof. of Pathology Position - Persian: استاد پاتولوژی Latest degree: phd Area of specialty/work: 026 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Alzahra Hospital, South Artesh Aveshareati Street Street address - Persian: ارتششریعتی جنوبی چهار راه باغشمال City - English: Tabriz City - Persian: تبریزTabriz Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5138815941 Phone: +98 41 3556 95433555 6943 Mobile: +98 914 313 8399 Fax: Email: arashkakiarashkhaki@yahoo.com; wrhrcenter@gmail.com Web page address: https://pmcpharma.org
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr.Elaheh Ouladsahebmadarek
Full name of responsible person - Persian: دکتر الهه اولاد صاحب مدارک
Position - English: Prof. of Ob & Gyn
Position - Persian: استاد- متخصص زنان و مامایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University Of Medical Sciences,Golgasht Street,
Street address - Persian: خیابان گلگشت دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3556 9543
Mobile: +98 914 114 4132
Fax:
Email: Ainehchi.nava@gmail.com; wrhrcenter@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr.Elaheh Ouladsahebmadarek
Full name of responsible person - Persian: دکتر الهه اولاد صاحب مدارک
Position - English: Prof. of Ob & Gyn
Position - Persian: استاد- متخصص زنان و مامایی
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University Of Medical Sciences,Golgasht Street,
Street address - Persian: خیابان گلگشت دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 3554 1221
Mobile: +98 914 114 4132
Fax:
Email: wrhrcenter@gmail.com
Web page address: https://wrhrc-en.tbzmed.ac.ir/
contact.organization_id: Name of organization / entity - English: Tabriz University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr.Elaheh Ouladsahebmadarek Full name of responsible person - Persian: دکتر الهه اولاد صاحب مدارک Position - English: Prof. of Ob & Gyn Position - Persian: استاد- متخصص زنان و مامایی Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tabriz University Of Medical Sciences,Golgasht Street, Street address - Persian: خیابان گلگشت دانشگاه علوم پزشکی تبریز City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5138665793 Phone: +98 41 3556 95433554 1221 Mobile: +98 914 114 4132 Fax: Email: Ainehchi.nava@gmail.com; wrhrcenter@gmail.com Web page address: https://wrhrc-en.tbzmed.ac.ir/
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tabriz University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr.Elaheh Ouladsahebmadarek
Full name of responsible person - Persian: دکتر الهه اولاد صاحب مدارک
Position - English: Prof. of Ob & Gyn
Position - Persian: استاد- متخصص زنان و زايمان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University Of Medical Sciences,Golgasht Street,
Street address - Persian: خیابان گلگشت-دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3556 9543
Mobile: +98 914 114 4132
Fax:
Email: Ainehchi.nava@gmail.com; wrhrcenter@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr.Elaheh Ouladsahebmadarek
Full name of responsible person - Persian: دکتر الهه اولاد صاحب مدارک
Position - English: Prof. of Ob & Gyn
Position - Persian: استاد- متخصص زنان و زايمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University Of Medical Sciences,Golgasht Street,
Street address - Persian: خیابان گلگشت-دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 3554 1221
Mobile: +98 914 114 4132
Fax:
Email: wrhrcenter@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr.Elaheh Ouladsahebmadarek Full name of responsible person - Persian: دکتر الهه اولاد صاحب مدارک Position - English: Prof. of Ob & Gyn Position - Persian: استاد- متخصص زنان و زايمان Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tabriz University Of Medical Sciences,Golgasht Street, Street address - Persian: خیابان گلگشت-دانشگاه علوم پزشکی تبریز City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5138665793 Phone: +98 41 3556 95433554 1221 Mobile: +98 914 114 4132 Fax: Email: Ainehchi.nava@gmail.com; wrhrcenter@gmail.com Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
empty
age of patient
age of patient
empty
سن بیمار
سن بیمار
empty
September 2019
September 2019
empty
شهریور ماه 1398,
شهریور ماه 1398,
empty
Academic member of universities
Academic member of universities
empty
اعضا هیت علمی دانشگاهها
اعضا هیت علمی دانشگاهها
empty
Ministry of Health and education
Ministry of Health and education
empty
وزارت بهداشت و درمان و آموزش پزشکی
وزارت بهداشت و درمان و آموزش پزشکی
empty
Womens Reproductive Health Research Center Tabriz University of Medical sciences , Dr Nava Ainehchi 00984135541221
Womens Reproductive Health Research Center Tabriz University of Medical sciences , Dr Nava Ainehchi 00984135541221
empty
دکتر نوا آیینه چی-شماره تماس 00984135541221 - مرکز تحقیقات سلامت باروری زنان دانشگاه علوم پزشکی تبریز
دکتر نوا آیینه چی-شماره تماس 00984135541221 - مرکز تحقیقات سلامت باروری زنان دانشگاه علوم پزشکی تبریز
empty
Direct Contact to Womens Reproductive Health Research Center Tabriz University of Medical sciences- 2 months
Direct Contact to Womens Reproductive Health Research Center Tabriz University of Medical sciences- 2 months
empty
تماس مستقیم با مرکز تحقیقات سلامت باروری زنان دانشگاه علوم پزشکی تبریز-2 ماه
تماس مستقیم با مرکز تحقیقات سلامت باروری زنان دانشگاه علوم پزشکی تبریز-2 ماه
Protocol summary
Study aim
evaluate the effects of herbal Mixture in infertile women with Polycystic ovary syndrome (PCOS).
Design
This single-blind randomized clinical trial the participants were divided into three groups (g1: Clomiphene Citrate (CC); g2: herbal mixture; and g3: herbal mixture along with (CC) by random allocation software through randomized blocks of three and six with an allocation ratio of 1:1:1. For allocation concealment, according to sequence generation opaque and sealed envelopes No; each contain a letter designating the allocation. The 1envelope was dedicated to 1 participant and this process was followed to the end of the research.ample size was calculated based on three variables of MDA, Testosterone and HOMA-IR.
Settings and conduct
it was done in alzahra hospital ,TBZMED. All participants were informed about the purpose of the study, and an informed consent was obtained from each of them.
Participants/Inclusion and exclusion criteria
Inclusion: willing to participate in the study, having at least two out of three of the Rotterdam criteria (2003) for the diagnosis of PCOS, aged between 18–35 years old, having BMI less than 30, not receiving any treatment at least in the last 3 months.Exclusion: diabetes mellitus, use of medications such as those helping ovulation or insulin sensitizers, thyroid disorders, cholesterol-lowering drugs, smoking, Hypertension, cardiovascular diseases, Cushing syndrome, allergy to Mentha spicata , Zingiber officinale , Cinnamomum zeylanicum and Citrus Sinensis
Intervention groups
clomiphene citrate group from third- fifth day of menstruation for five days for three menstrual cycles; herbal mixture capsule group, herbal mixture capsule group along with CC for 3 months
Main outcome variables
Primary outcomes included serum levels of antioxidants blood biomarkers and sex hormones.Thyroid hormones and clinical features were considered as secondary outcomes.
General information
Reason for update
It was requested that some sections that were incomplete be completed.
Acronym
IRCT registration information
IRCT registration number:IRCT201509295563N7
Registration date:2016-01-09, 1394/10/19
Registration timing:registered_while_recruiting
Last update:2020-01-16, 1398/10/26
Update count:1
Registration date
2016-01-09, 1394/10/19
Registrant information
Name
Elaheh Ouladsahebmadarek
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
madarek@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of herbal medicine (Mixture) with Clomiphene citrate in treatment of Poly-cystic ovary syndrome (PCOS) and fertility rate in infertile women referring toTabriz Al-Zahra hospital.
Public title
The effects of herbal mixture in infertile women with Polycystic ovary syndrome (PCOS): a randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
willing to participate in the study
having at least two out of three of the Rotterdam criteria (2003) for the diagnosis of PCOS
aged between 18–35 years old
having body mass index (BMI) less than 30
not receiving any treatment at least in the last 3 months (wash out)
Exclusion criteria:
patients with diabetes mellitus
use of medications such as those helping ovulation or insulin sensitizers
thyroid disorders
cholesterol-lowering drugs
smoking
hypertension
cardiovascular diseases
Cushing syndrome
allergy to Mentha spicata (spearmint), Zingiber officinale (ginger) ,Cinnamomum zeylanicum (cinnamon), and Citrus Sinensis (sweet orange)
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were divided into three groups (group 1: Clomiphene Citrate (CC); group 2: herbal mixture; and group 3: herbal mixture along with (CC) by random allocation software through randomized blocks of three and six with an allocation ratio of 1:1:1. For allocation concealment, according to sequence generation opaque and sealed envelopes numbered; each contain a letter designating the allocation. The first envelope was dedicated to first participant and this process was followed to the end of the research.Only the statistician was blind to the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistician was blind to the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arash Khaki
Street address
South shareati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138815941
Approval date
2015-10-03, 1394/07/11
Ethics committee reference number
TBZMED.REC.1394.576
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Treatment of ovarian cysts
Timepoint
Before the intervention, three months after intervention
Method of measurement
Ultrasound of the ovaries (ovarian size, number and size of follicles)
Secondary outcomes
1
Description
Pregnancy
Timepoint
3 months after taking medicinal plants (Citro Plus)
Method of measurement
Positive BhcG
Intervention groups
1
Description
" :Intervention group: " herbal medicine (Mixture) 700 mgs/day continuous for 3 cycles.
Category
Treatment - Drugs
2
Description
"Control group" Clomiphene Citrate 50-150 mg for 3 cycles
Category
Treatment - Drugs
3
Description
'' :Intervention group: " herbal medicine (Mixture) 700 mgs/day continuous with Clomiphene Citrate 50-150 mg for 3 cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Khaki
Full name of responsible person
Arash Khaki
Street address
South shareati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138815941
Phone
+98 51 3554 1221
Email
arashkhaki@yahoo.com
Web page address
https://wrhrc-en.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
wrhrcenter@gmail.com
Web page address
https://wrhrc-en.tbzmed.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,Tabriz University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
PMC Pharmaceutical International Company
Full name of responsible person
Arash Khaki
Position
Prof. of Pathology
Latest degree
Ph.D.
Other areas of specialty/work
Pathology
Street address
South shareati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138815941
Phone
+98 41 3555 6943
Fax
Email
arashkhaki@yahoo.com
Web page address
https://pmcpharma.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Elaheh Ouladsahebmadarek
Position
Prof. of Ob & Gyn
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences,Golgasht Street,
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Fax
Email
wrhrcenter@gmail.com
Web page address
https://wrhrc-en.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Elaheh Ouladsahebmadarek
Position
Prof. of Ob & Gyn
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences,Golgasht Street,
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Fax
Email
wrhrcenter@gmail.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
age of patient
When the data will become available and for how long
September 2019
To whom data/document is available
Academic member of universities
Under which criteria data/document could be used
Ministry of Health and education
From where data/document is obtainable
Womens Reproductive Health Research Center Tabriz University of Medical sciences , Dr Nava Ainehchi 00984135541221
What processes are involved for a request to access data/document
Direct Contact to Womens Reproductive Health Research Center Tabriz University of Medical sciences- 2 months