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Protocol summary
PCOS is the biggest cause of infertility due to ovulation disorders and the management and treatment of ovulation and menstrual disorders includes approximately 30% of the high cost of treatment. Clomiphene is often prescribed for treatment. Resistance to clomiphene and its failure to treatment are both common. Clinical and laboratory findings of previous studies suggest that acupuncture may induce ovulation and increase fertility in women with PCOS. This study aims to compare the effect of acupuncture with clomiphene to induce ovulation in PCOS. All patients with polycystic ovary syndrome referred to gynecology clinic of Imam Reza (AS) based on Rotterdam diagnostic criteria will be entered the study by simple-non probability sampling if they conform with inclusion and exclusion criteria, and will be put in one of two groups, intervention (real acupuncture + placebo clomiphene) and control (sham acupuncture + clomiphene). Treatment will start at day 3 after the start of spontaneous period or a Bleeding after progesterone consumption in both groups. Both groups will be treated with acupuncture/sham acupuncture for a maximum of 32 treatment sessions over 16 weeks (twice a week). Clomiphene citrate 50 mg daily will be prescribed to patients in control group for 5 days in 5 cycles. Same regimen will be prescribed for placebo in the intervention group. Serial ovarian trans-vaginal ultrasonography will be done from the third cycle day every 3 days until ovulation occurs. Detection of side effects during the study period will be recorded and compared in both groups.
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PCOS is the biggest cause of infertility due to ovulation disorders and the management and treatment of ovulation and menstrual disorders includes approximately 30% of the high cost of treatment. Clomiphene is often prescribed for treatment. Resistance to clomiphene and its failure to treatment are both common. Clinical and laboratory findings of previous studies suggest that acupuncture may induce ovulation and increase fertility in women with PCOS. This study aims to compare the effect of acupuncture with clomiphene to induce ovulation in PCOS. All patients with polycystic ovary syndrome referred to gynecology clinic of Imam Reza (AS) based on Rotterdam diagnostic criteria will be entered the study by simple-non probability sampling if they conform with inclusion and exclusion criteria, and will be put in one of two groups, intervention (real acupuncture + placebo clomiphene) and control (sham acupuncture + clomiphene). Treatment will start at day 3 after the start of spontaneous period or a Bleeding after progesterone consumption in both groups. Both groups will be treated with acupuncture/sham acupuncture for a maximum of 32 treatment sessions over 16 weeks (twice a week). Clomiphene citrate 50 mg daily will be prescribed to patients in control group for 5 days in 5 cycles. Same regimen will be prescribed for placebo in the intervention group. Serial ovarian trans-vaginal ultrasonography will be done from the third cycle day every 3 days until ovulation occurs. Detection of side effects during the study period will be recorded and compared in both groups.
PCOS بزرگترین علت ناباروری به دلیل اختلال تخمک گذاری است، و مدیریت و درمان اختلال تخمک گذاری و اختلال سیکل قاعدگی حدود 3/1 از هزینه های بالای درمان PCO را شامل می شود. درمان تجویز شده اغلب کلومیفن است. مقاومت به کلومیفن و شکست کلومیفن هر دو شایع هستند. یافته های مطالعات بالینی و آزمایشگاهی قبلی پیشنهاد کننده آنند که طب سوزنی ممکن است در خانم های مبتلا به PCOS، تخمک گذاری را تحریک و باروری را افزایش دهد. این پژوهش با هدف مقایسه تاثیر طب سوزنی با کلومیفن در القای تخمک گذاری در سندرم تخمدان پلی کیستیک انجام خواهد شد. کلیه بیماران مبتلا به سندرم تخمدان پلی کیستیک مراجعه کننده به درمانگاه زنان بیمارستان امام رضا (ع) بر اساس کرایتریای تشخیصی روتردام با نمونه گیری غیر احتمالی آسان و در صورت تطابق با معیارهای ورود و خروج مطالعه وارد یکی از دو گروه مداخله (طب سوزنی واقعی +پلاسبوی کلومیفن) و کنترل (طب سوزنی شم + کلومیفن) خواهند شد. درمان در هر دو گروه در روز 3 بعد از شروع یک پریود خودبخودی یا یک خونریزی بدنبال مصرف پروژسترون شروع خواهد شد. هر دو گروه تحت درمان با طب سوزنی/ طب سوزنی شم به مدت حداکثر 32 جلسه درمانی در طی 16 هفته (دو بار در هفته) قرار خواهند گرفت. 50 میلی گرم کلومیفن سیترات روزانه به مدت 5 روز برای 5 سیکل به گروه کنترل و پلاسبوی آن با همین متد به گروه مداخله داده خواهد شد. سونو گرافی سریال واژینال تخمدان از روز سوم سیکل هر 3 روز یکبار تا اثبات تخمک گذاری انجام خواهد شد. عوارض جانبی بروز کرده در دو گروه در طول مدت زمان مطالعه ثبت و مقایسه خواهد شد.
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PCOS بزرگترین علت ناباروری به دلیل اختلال تخمک گذاری است، و مدیریت و درمان اختلال تخمک گذاری و اختلال سیکل قاعدگی حدود 3/1 از هزینه های بالای درمان PCO را شامل می شود. درمان تجویز شده اغلب کلومیفن است. مقاومت به کلومیفن و شکست کلومیفن هر دو شایع هستند. یافته های مطالعات بالینی و آزمایشگاهی قبلی پیشنهاد کننده آنند که طب سوزنی ممکن است در خانم های مبتلا به PCOS، تخمک گذاری را تحریک و باروری را افزایش دهد. این پژوهش با هدف مقایسه تاثیر طب سوزنی با کلومیفن در القای تخمک گذاری در سندرم تخمدان پلی کیستیک انجام خواهد شد. کلیه بیماران مبتلا به سندرم تخمدان پلی کیستیک مراجعه کننده به درمانگاه زنان بیمارستان امام رضا (ع) بر اساس کرایتریای تشخیصی روتردام با نمونه گیری غیر احتمالی آسان و در صورت تطابق با معیارهای ورود و خروج مطالعه وارد یکی از دو گروه مداخله (طب سوزنی واقعی +پلاسبوی کلومیفن) و کنترل (طب سوزنی شم + کلومیفن) خواهند شد. درمان در هر دو گروه در روز 3 بعد از شروع یک پریود خودبخودی یا یک خونریزی بدنبال مصرف پروژسترون شروع خواهد شد. هر دو گروه تحت درمان با طب سوزنی/ طب سوزنی شم به مدت حداکثر 32 جلسه درمانی در طی 16 هفته (دو بار در هفته) قرار خواهند گرفت. 50 میلی گرم کلومیفن سیترات روزانه به مدت 5 روز برای 5 سیکل به گروه کنترل و پلاسبوی آن با همین متد به گروه مداخله داده خواهد شد. سونو گرافی سریال واژینال تخمدان از روز سوم سیکل هر 3 روز یکبار تا اثبات تخمک گذاری انجام خواهد شد. عوارض جانبی بروز کرده در دو گروه در طول مدت زمان مطالعه ثبت و مقایسه خواهد شد.
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To compare the effectiveness of acupuncture with clomiphene in stimulating ovulation in infertile women with polycystic ovary syndrome
To compare the effectiveness of acupuncture with clomiphene in stimulating ovulation in infertile women with polycystic ovary syndrome
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مقايسه میزان تاثیر طب سوزنی با کلومیفن در تحریک تخمک گذاری در خانمهای نابارور مبتلا به سندرم تخمدان پلی کیستیک
مقايسه میزان تاثیر طب سوزنی با کلومیفن در تحریک تخمک گذاری در خانمهای نابارور مبتلا به سندرم تخمدان پلی کیستیک
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Clinical trial with control group, parallel, single-blind, randomized, on 110 patients with simple randomization.
Clinical trial with control group, parallel, single-blind, randomized, on 110 patients with simple randomization.
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کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده، بر روی 110بیمار با تصادفی سازی ساده
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده، بر روی 110بیمار با تصادفی سازی ساده
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Clinical trial on infertile PCOS patients referred to women's clinic of Imam Reza Hospital and Milad Infertility Center, Mashhad, Iran
Acupuncture (real or sham) for up to 3 cycles, twice a week
Clomiphene (real or placebo) at a daily rate of 50, 100 and 150 mg in the first to third cycle of treatment from the third day of the cycle for 5 days
Evaluation based on serial vaginal ultrasound in each cycle in terms of follicle growth and proof of ovulation
In this study, patients were blinded to the type of treatment. Also, gynecologist, statistical analyst and research assistant (interrogator) were blinded to the study groups. Only the acupuncturist was aware of patients' groups.
Clinical trial on infertile PCOS patients referred to women's clinic of Imam Reza Hospital and Milad Infertility Center, Mashhad, Iran Acupuncture (real or sham) for up to 3 cycles, twice a week Clomiphene (real or placebo) at a daily rate of 50, 100 and 150 mg in the first to third cycle of treatment from the third day of the cycle for 5 days Evaluation based on serial vaginal ultrasound in each cycle in terms of follicle growth and proof of ovulation In this study, patients were blinded to the type of treatment. Also, gynecologist, statistical analyst and research assistant (interrogator) were blinded to the study groups. Only the acupuncturist was aware of patients' groups.
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کارآزمایی بالینی بر روی بیماران نابارور PCOS مراجعه کننده به درمانگاه زنان بیمارستان امام رضا و مرکز ناباروری میلاد، مشهد، ایران
طب سوزنی (واقعی یا ساختگی) به مدت حداکثر 3 سیکل، دو بار در هفته
کلومیفن (واقعی یا پلاسبو) به میزان روزانه 50، 100 و 150 میلی گرم در سیکل اول تا سوم درمان از روز سوم سیکل به مدت 5 روز
بررسی بیماران با سونوگرافی واژینال سریال در هر سیکل از نظر رشد فوليكول و اثبات تخمک گذاری
در این مطالعه بیماران نسبت به نوع درمان کور بودند. همچنین متخصص زنان و زایمان، تحلیل گر آماری و کمک پژوهشگر (پرسشگر) نسبت به گروههای مطالعه کورسازی شدند. تنها متخصص طب سوزنی از گروههای بیماران اطلاع داشت.
کارآزمایی بالینی بر روی بیماران نابارور PCOS مراجعه کننده به درمانگاه زنان بیمارستان امام رضا و مرکز ناباروری میلاد، مشهد، ایران طب سوزنی (واقعی یا ساختگی) به مدت حداکثر 3 سیکل، دو بار در هفته کلومیفن (واقعی یا پلاسبو) به میزان روزانه 50، 100 و 150 میلی گرم در سیکل اول تا سوم درمان از روز سوم سیکل به مدت 5 روز بررسی بیماران با سونوگرافی واژینال سریال در هر سیکل از نظر رشد فوليكول و اثبات تخمک گذاری در این مطالعه بیماران نسبت به نوع درمان کور بودند. همچنین متخصص زنان و زایمان، تحلیل گر آماری و کمک پژوهشگر (پرسشگر) نسبت به گروههای مطالعه کورسازی شدند. تنها متخصص طب سوزنی از گروههای بیماران اطلاع داشت.
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Inclusion conditions: age between 20 and 40 years; suffering from infertility and polycystic ovary syndrome according to the Rotterdam criteria.
Conditions of non-inclusion: simultaneous presence of other endocrine, hepatic and renal disorders; taking hormonal or herbal medicines containing hormones during the last three months; pregnancy, miscarriage or childbirth in the last 6 months; history of thromboembolism; drug dependence; Uncontrolled blood pressure
Inclusion conditions: age between 20 and 40 years; suffering from infertility and polycystic ovary syndrome according to the Rotterdam criteria. Conditions of non-inclusion: simultaneous presence of other endocrine, hepatic and renal disorders; taking hormonal or herbal medicines containing hormones during the last three months; pregnancy, miscarriage or childbirth in the last 6 months; history of thromboembolism; drug dependence; Uncontrolled blood pressure
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شرایط ورود: سن بین 20 تا 40 سال؛ ابتلا به ناباروری و سندرم تخمدان پلی کیستیک طبق کرایتریای روتردام
شرایط عدم ورود: وجود همزمان سایر اختلالات اندوکرین، کبدی و کلیوی؛ مصرف داروهای هورمونی یا گیاهی حاوی هورمون در طی سه ماه گذشته؛ حاملگی، سقط یا زایمان در 6 ماه اخیر؛ سابقه ترومبوآمبولی؛ وابستگی دارویی؛ فشار خون کنترل نشده
شرایط ورود: سن بین 20 تا 40 سال؛ ابتلا به ناباروری و سندرم تخمدان پلی کیستیک طبق کرایتریای روتردام شرایط عدم ورود: وجود همزمان سایر اختلالات اندوکرین، کبدی و کلیوی؛ مصرف داروهای هورمونی یا گیاهی حاوی هورمون در طی سه ماه گذشته؛ حاملگی، سقط یا زایمان در 6 ماه اخیر؛ سابقه ترومبوآمبولی؛ وابستگی دارویی؛ فشار خون کنترل نشده
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intervention group (real acupuncture + clomiphene placebo)
control group (real clomiphene + sham acupuncture)
intervention group (real acupuncture + clomiphene placebo) control group (real clomiphene + sham acupuncture)
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گروه مداخله (طب سوزنی واقعی+ کلومیفن پلاسبو)
گروه کنترل (کلومیفن واقعی+ طب سوزنی ساختگی)
گروه مداخله (طب سوزنی واقعی+ کلومیفن پلاسبو) گروه کنترل (کلومیفن واقعی+ طب سوزنی ساختگی)
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Primary endpoint: ovulation rate in two groups
Secondary outcomes: the number of developing follicles (greater than or equal to 14 mm) and mature follicles (greater than or equal to 18 mm); Adverse events
Primary endpoint: ovulation rate in two groups Secondary outcomes: the number of developing follicles (greater than or equal to 14 mm) and mature follicles (greater than or equal to 18 mm); Adverse events
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پیامد اصلی: میزان تخمک گذاری
پیامدهای ثانویه: تعداد فولیکول در حال رشد (بیشتر یا مساوی 14 میلی متر) و ماچور (بیشتر یا مساوی 18 میلی متر)؛ عوارض جانبی
پیامد اصلی: میزان تخمک گذاری پیامدهای ثانویه: تعداد فولیکول در حال رشد (بیشتر یا مساوی 14 میلی متر) و ماچور (بیشتر یا مساوی 18 میلی متر)؛ عوارض جانبی
General information
Double blinded
Single blinded
doublsingl
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1
1
1
1
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77
77
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2015-12-25, 1394/10/04
2015-12-25 00:00:00
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2016-07-24, 1395/05/03
2016-07-24 00:00:00
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2016-10-30, 1395/08/09
2016-10-30 00:00:00
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We decided to include the actual day patients entered the study
We decided to include the actual day patients entered the study
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ما تصمیم گرفتیم روز واقعی که بیماران داخل مطالعه شدند را ذکر کنیم
ما تصمیم گرفتیم روز واقعی که بیماران داخل مطالعه شدند را ذکر کنیم
Patients with infertility and polycystic ovary syndrome
Patients with infertility and polycystic ovary syndrome
بیماران مبتلا به ناباروری و سندرم تخمدان پلی کیستیک
بیماران مبتلا به ناباروری و سندرم تخمدان پلی کیستیک
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simple randomization
simple randomization
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تصادفی سازی ساده
تصادفی سازی ساده
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In this study, patients were blinded to the type of treatment. Also, the gynecologist, statistical analyst and research assistant (interrogator) were blinded to the study groups. Only the acupuncturist was informed of the patients' groups.
In this study, patients were blinded to the type of treatment. Also, the gynecologist, statistical analyst and research assistant (interrogator) were blinded to the study groups. Only the acupuncturist was informed of the patients' groups.
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در این مطالعه بیماران نسبت به نوع درمان کور بودند. همچنین متخصص زنان و زایمان، تحلیل گر آماری و کمک پژوهشگر (پرسشگر) نسبت به گروههای مطالعه کورسازی شدند. تنها متخصص طب سوزنی از گروههای بیماران اطلاع داشت.
در این مطالعه بیماران نسبت به نوع درمان کور بودند. همچنین متخصص زنان و زایمان، تحلیل گر آماری و کمک پژوهشگر (پرسشگر) نسبت به گروههای مطالعه کورسازی شدند. تنها متخصص طب سوزنی از گروههای بیماران اطلاع داشت.
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Ethics committees
#1
940058
IR.MUMS.fm.REC.1394.346
940058IR.MUMS.fm.REC.1394.346
Recruitment centers
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Name of recruitment center - English: Imam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا (ع)
Full name of responsible person - English: Dr Leili Hafizi Lotfabadi
Full name of responsible person - Persian: دکتر لیلی حفیظی لطف آبادی
Street address - English: Gynecology clinic, Imam Reza Hospital
Street address - Persian: بیمارستان امام رضا، درمانگاه زنان
City - English: Mashhad
City - Persian: مشهد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Imam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا (ع)
Full name of responsible person - English: Dr Leili Hafizi Lotfabadi
Full name of responsible person - Persian: دکتر لیلی حفیظی لطف آبادی
Street address - English: Gynecology clinic, Imam Reza Hospital
Street address - Persian: بیمارستان امام رضا، درمانگاه زنان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 91379 13316
Phone: +98 51 3854 3031
Fax:
Email: hafizil@mums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza hospital Name of recruitment center - Persian: بیمارستان امام رضا (ع) Full name of responsible person - English: Dr Leili Hafizi Lotfabadi Full name of responsible person - Persian: دکتر لیلی حفیظی لطف آبادی Street address - English: Gynecology clinic, Imam Reza Hospital Street address - Persian: بیمارستان امام رضا، درمانگاه زنان City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 91379 13316 Phone: +98 51 3854 3031 Fax: Email: hafizil@mums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr Mohsen Tafaghodi
Full name of responsible person - Persian: دکتر محسن تفقدی
Street address - English: MUM's central office, Daneshgah street, Mashhad
Street address - Persian: خیابان دانشگاه، سازمان مرکزی دانشگاه، معاونت پژوهشی
City - English: Mashhad
City - Persian: مشهد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr Mohsen Tafaghodi
Full name of responsible person - Persian: دکتر محسن تفقدی
Street address - English: MUM's central office, Daneshgah street, Mashhad
Street address - Persian: خیابان دانشگاه، سازمان مرکزی دانشگاه، معاونت پژوهشی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3841 2081
Fax:
Email: ramresearch@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Dr Mohsen Tafaghodi Full name of responsible person - Persian: دکتر محسن تفقدی Street address - English: MUM's central office, Daneshgah street, Mashhad Street address - Persian: خیابان دانشگاه، سازمان مرکزی دانشگاه، معاونت پژوهشی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9138813944 Phone: +98 51 3841 2081 Fax: Email: ramresearch@mums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Department of Gynecology, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه زنان و زایمان
Full name of responsible person - English: Dr. Hamideh Azizi
Full name of responsible person - Persian: دکتر حمیده عزیزی
Position - English: Gynecology resident
Position - Persian: دستیار تخصصی زنان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Gynecology, Imam Reza hospital
Street address - Persian: بیمارستان امام رضا (ع)، بخش زنان و زایمان
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 915 519 8656
Mobile:
Fax:
Email: azizih921@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Gynecology, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه زنان و زایمان
Full name of responsible person - English: Dr. Hamideh Azizi
Full name of responsible person - Persian: دکتر حمیده عزیزی
Position - English: Gynecology resident
Position - Persian: دستیار تخصصی زنان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Gynecology, Imam Reza hospital
Street address - Persian: بیمارستان امام رضا (ع)، بخش زنان و زایمان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9176885378
Phone: +98 915 519 8656
Mobile: +98 915 519 8656
Fax:
Email: azizih921@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Gynecology, Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه زنان و زایمان Full name of responsible person - English: Dr. Hamideh Azizi Full name of responsible person - Persian: دکتر حمیده عزیزی Position - English: Gynecology resident Position - Persian: دستیار تخصصی زنان Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Department of Gynecology, Imam Reza hospital Street address - Persian: بیمارستان امام رضا (ع)، بخش زنان و زایمان City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9176885378 Phone: +98 915 519 8656 Mobile: +98 915 519 8656 Fax: Email: azizih921@mums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Department of Chinese and complementary Medicine
Name of organization / entity - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل
Full name of responsible person - English: Dr. Hoda Azizi
Full name of responsible person - Persian: دکتر هدا عزیزی
Position - English: MD, PhD in Acupuncture, Assistant Professor
Position - Persian: پزشک و دکترای تخصصی بالینی طب سوزنی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Chinese and complementary Medicine
Street address - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 51 3855 2188
Mobile: +98 915 313 7194
Fax:
Email: azizih@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Chinese and complementary Medicine
Name of organization / entity - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل
Full name of responsible person - English: Dr. Hoda Azizi
Full name of responsible person - Persian: دکتر هدا عزیزی
Position - English: MD, PhD in Acupuncture, Assistant Professor
Position - Persian: پزشک و دکترای تخصصی بالینی طب سوزنی
Latest degree: phd
Area of specialty/work:
Area of specialty/work title - English: Acupuncture
Area of specialty/work title - Persian: طب سوزنی
Street address - English: Department of Chinese and complementary Medicine
Street address - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 51 3855 2188
Mobile: +98 915 313 7194
Fax:
Email: azizih@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Chinese and complementary Medicine Name of organization / entity - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل Full name of responsible person - English: Dr. Hoda Azizi Full name of responsible person - Persian: دکتر هدا عزیزی Position - English: MD, PhD in Acupuncture, Assistant Professor Position - Persian: پزشک و دکترای تخصصی بالینی طب سوزنی Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: Acupuncture Area of specialty/work title - Persian: طب سوزنی Street address - English: Department of Chinese and complementary Medicine Street address - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9177948564 Phone: +98 51 3855 2188 Mobile: +98 915 313 7194 Fax: Email: azizih@mums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr Hoda Azizi
Full name of responsible person - Persian: دکتر هدا عزیزی
Position - English: Assistant Professor
Position - Persian: پزشک و دکترای تخصصی بالینی طب سوزنی/ استادیار دانشگاه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Chinese and Complementary Medicine
Street address - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل، خیابان رازی شرقی
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Mobile: +98 915 313 7194
Fax:
Email: azizih@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr Hoda Azizi
Full name of responsible person - Persian: دکتر هدا عزیزی
Position - English: Assistant Professor
Position - Persian: پزشک و دکترای تخصصی بالینی طب سوزنی/ استادیار دانشگاه
Latest degree: phd
Area of specialty/work: 0
Area of specialty/work title - English: Acupuncture
Area of specialty/work title - Persian: طب سوزنی
Street address - English: Department of Chinese and Complementary Medicine
Street address - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل، خیابان رازی شرقی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 51 3882 9279
Mobile: +98 915 313 7194
Fax:
Email: azizih@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Dr Hoda Azizi Full name of responsible person - Persian: دکتر هدا عزیزی Position - English: Assistant Professor Position - Persian: پزشک و دکترای تخصصی بالینی طب سوزنی/ استادیار دانشگاه Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: Acupuncture Area of specialty/work title - Persian: طب سوزنی Street address - English: Department of Chinese and Complementary Medicine Street address - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل، خیابان رازی شرقی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9177948564 Phone: +98 51 3882 9279 Mobile: +98 915 313 7194 Fax: Email: azizih@mums.ac.ir Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
There is no further information.
There is no further information.
empty
اطلاعات بیشتری وجود ندارد.
اطلاعات بیشتری وجود ندارد.
Protocol summary
Study aim
To compare the effectiveness of acupuncture with clomiphene in stimulating ovulation in infertile women with polycystic ovary syndrome
Design
Clinical trial with control group, parallel, single-blind, randomized, on 110 patients with simple randomization.
Settings and conduct
Clinical trial on infertile PCOS patients referred to women's clinic of Imam Reza Hospital and Milad Infertility Center, Mashhad, Iran
Acupuncture (real or sham) for up to 3 cycles, twice a week
Clomiphene (real or placebo) at a daily rate of 50, 100 and 150 mg in the first to third cycle of treatment from the third day of the cycle for 5 days
Evaluation based on serial vaginal ultrasound in each cycle in terms of follicle growth and proof of ovulation
In this study, patients were blinded to the type of treatment. Also, gynecologist, statistical analyst and research assistant (interrogator) were blinded to the study groups. Only the acupuncturist was aware of patients' groups.
Participants/Inclusion and exclusion criteria
Inclusion conditions: age between 20 and 40 years; suffering from infertility and polycystic ovary syndrome according to the Rotterdam criteria.
Conditions of non-inclusion: simultaneous presence of other endocrine, hepatic and renal disorders; taking hormonal or herbal medicines containing hormones during the last three months; pregnancy, miscarriage or childbirth in the last 6 months; history of thromboembolism; drug dependence; Uncontrolled blood pressure
Intervention groups
intervention group (real acupuncture + clomiphene placebo)
control group (real clomiphene + sham acupuncture)
Main outcome variables
Primary endpoint: ovulation rate in two groups
Secondary outcomes: the number of developing follicles (greater than or equal to 14 mm) and mature follicles (greater than or equal to 18 mm); Adverse events
General information
Reason for update
We decided to include the actual day patients entered the study
Acronym
IRCT registration information
IRCT registration number:IRCT201512057265N3
Registration date:2015-12-23, 1394/10/02
Registration timing:prospective
Last update:2023-06-28, 1402/04/07
Update count:1
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-13, 1394/09/22
Expected recruitment end date
2016-05-11, 1395/02/22
Actual recruitment start date
2015-12-25, 1394/10/04
Actual recruitment end date
2016-07-24, 1395/05/03
Trial completion date
2016-10-30, 1395/08/09
Scientific title
Comparison acupuncture with Clomiphene for ovulation induction in polycystic ovary syndrome
Public title
Comparison acupuncture with Clomiphene for ovulation induction in polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with infertility and polycystic ovary syndrome
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Actual sample size reached:
77
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients were blinded to the type of treatment. Also, the gynecologist, statistical analyst and research assistant (interrogator) were blinded to the study groups. Only the acupuncturist was informed of the patients' groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
MUM's central office, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
IR.MUMS.fm.REC.1394.346
Health conditions studied
1
Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
F28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Ovulation
Timepoint
Every three days since subjects entered the study
Method of measurement
Serial vaginal ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: sham acupuncture + clomiphene
Category
Treatment - Other
2
Description
Intervention group: Real acupuncture + placebo Clomiphene
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr Leili Hafizi Lotfabadi
Street address
Gynecology clinic, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91379 13316
Phone
+98 51 3854 3031
Email
hafizil@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
MUM's central office, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Department of Gynecology, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hamideh Azizi
Position
Gynecology resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Gynecology, Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176885378
Phone
+98 915 519 8656
Fax
Email
azizih921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Chinese and complementary Medicine
Full name of responsible person
Dr. Hoda Azizi
Position
MD, PhD in Acupuncture, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Acupuncture
Street address
Department of Chinese and complementary Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3855 2188
Fax
Email
azizih@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoda Azizi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Acupuncture
Street address
Department of Chinese and Complementary Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Fax
Email
azizih@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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