History
# Registration date Revision Id
2 2021-03-27, 1400/01/07 181146
1 2015-10-12, 1394/07/20 18451
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  • Protocol summary

    Objectives: To examine the effects of Mogza herbal capsules on count, motility and morphology of sperms and expression of antioxidant genes in them. Design: Participants are divided into two groups by permutation randomization method: control group (who are received standard male infertility drug prescribed by physican) and case group (who are received researcher's drug as Mogza in addition to standard male infertility drug prescribed by physican). Members of both groups are trained to go walking for 20 minutes as callisthenics, three times a week. According to the list given to them, they should follow a special diet, including a plate of vegetables, certain amounts and kinds of fruits in a week and a ban on fastfood consumption, etc. Setting and conduct: Semen samples are collected by masturbation in two to four days after their last sexual intercourse and are divided into three groups. Semen analysis are conducted on the first group immediately and in the other group, semen samples are stored in separate 1 ml tubes (which are free of DNAse and RNAse) in nitrogen tank in -80°C, to do further molecular tests (DNA extraction and anti oxidant gene expression) and measurements of semen enzymes activities. In third group, free levels of F2t Isoprostane in plasma are measured by ELISA method, using Caymann Chemical and Ann Arbor commercial kits. Participants: Oligospermic and asthenospermic patients in the age ranges of 20-40 years with normal genital anatomy (after necessary lab tests by Urology specialist) who are referred to IVF Center of Om Leila hospital are chosen by researcher-made checklist. Individuals with varicocele, prostatitis, epidimitis, orchidism, mumps, testicular trauma, hyperthyroidism, hypothyroisdism, diabetes, thalassemia major, genetic disorders affecting infertility, history of hernia surgery, vasectomy and who are consume antioxidant drugs, are excluded from study. Interventions: Four gram palm pollen are consumed daily in case groups as 1 gram Mogza capsules (two capsules in the morning and two capsules at night, one hour after meal) for two and a half months. Variables of main outcome: Count, motility and morphology of sperms and expression of antioxidant genes (SOD, CAT, GPX, NRF2 and KEAP1) in them.
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    اهداف: ارزیابی تاثیرات کپسول گیاهی مگزا بر پارامترهای تعداد، حرکت و مرفولوژی اسپرم ها و بیان ژنهای انتی اکسیدان در آن ها. طراحی: شرکت کنندگان در این مطالعه با روش تصادفی سازی جایگشتی به دو گروه تقسیم می شوند: گروه کنترل ( گروهی که داروی استاندارد درمان ناباروری مردان تجویز شده توسط پزشک را دریافت می کند) و گروه کیس (گروهی که علاوه داروی استاندارد درمان ناباروری مردان تجویز شده توسط پزشک، داروی محقق تحت عنوان مگزا را نیز دریافت می کند). به اعضای دو گروه تعلیم داده می شود که یک ورزش سبک 20 دقیقه ای پیاده روی را سه بار در هفته انجام دهند و رژیم غذایی معینی را طبق لیستی که به انها داده میشود، رعایت کنند که شامل مصرف یک بشقاب سبزی و مصرف مقدار و نوع مشخصی از میوه جات در طی یک هفته و عدم استفاده از غذا های فست فود و غیره می باشد. نحوه انجام: دو الی چهار روز پس از آخرین مقاربت جنسی، نمونه سیمن بصورت خود تحریکی از این افراد جمع آوری می شود. نمونه های سیمن شرکت کنندگان نیز پس از جمع آوری به سه گروه تقسیم می شوند، گروه یک را بلافاصله تحت ازمایشات انالیز سیمن قرار می دهیم و در گروه دیگر، نمونه مایع منی در لوله های با حجم یک میلی لیتر (که عاری از آنزیم های DNAآز و RNAآز هستند) در تانک نیتروژنی با دمای منفی 80 درجه سانتی گراد نگهداری می شوند تا برای انجام آزمایشات مولکولی بعدی (استخراج DNA و بیان ژن آنتی اکسیدان) و اندازه گیری فعالیت آنزیم های سیمن مورد استفاده قرار بگیرند. بر روی نمونه گروه سوم، اندازه گیری سطح آزاد ایزوپرستان F2t در پلاسمای خون بوسیله روش الایزا و با استفاده از کیت های تجاری Caymann Chemical و Ann Arbor انجام می گیرد. شرکت کنندگان: بیماران الیگواسپرمیک و استنواسپرمیک 20 تا 40 ساله (پس از انجام آزمایش های لازم توسط متخصص ارولوژی) مراجعه کننده به مرکز IVF بیمارستان ام لیلا که آناتومی ناحیه تناسلی نرمال دارند، بوسیله چک لیست محقق ساخته انتخاب می شوند و افراد دارای بیماری هایی از قبیل واریکوسل، التهاب پروستات، التهاب مجاری اپیدیدم، ارکیدیسم، اوریون، ضربه به بیضه، هایپرتیروئیدیسم، هایپوتیروئیدیسم، دیابت، تالاسمی ماژور، بیماریهایی ژنتیکی موثر در ناباروری، سابقه ی اعمال جراحی فتق، وازکتومی و مصرف داروهای آنتی اکسیدان از مطالعه خارج می شوند. مداخلات: گرده نخل به میزان 4 گرم در روز به صورت کپسولهای یک گرمی مگزا (دو کپسول صبح و دو کپسول شب، یک ساعت بعد از غذا) به مدت دو ماه و نیم در گروه مداخله مصرف می شود. متغیر های پیامد اصلی: پارامترهای تعداد، حرکت و مرفولوژی اسپرم ها و بیان ژنهای انتی اکسیدان (CAT ،GPX ،NRF2 ،KEAP1 و SOD) در آن ها.
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    The aim of this study was to investigate: The effect of palm pollen on sexual parameters As well as the expression of antioxidant genes Sex hormones in infertile men
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    هدف از انجام این مطالعه: بررسی اثر گرده نخل بر پارامترهای جنسی همچنین بیان ژنهای انتی اکسیدانی وشاخص 8- ایزوپرستان هورمونهای جنسی در مردان نابارور بوده است.
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    single-blind, and comparative clinical trial
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    کارآزمایی بالینی ، یک سو کور و مقایسه ای
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    This study was conducted during 2015. Palm pollen at a dose of 400 mg / kg in gelatin capsules was used for two consecutive months to treat eligible individuals. The control group was selected. Semen samples were analyzed before and after palm pollen treatment in the case group and also semen samples in the control group according to WHO guidelines.
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    این مطالعه طی سال1394 انجام شد. گرده نخل به میزان 400 mg/kg در کپسول های ژلاتینی به مدت دو ماه متوالی برای درمان افراد واجد شرایط مورد استفاده قرار گرفت علاوه بر این ، 20 مرد بارور که طی دو سال گذشته صاحب فرزند شده بودند و نمونه های مایع منی آنها به عنوان گروه شاهد انتخاب شدند. نمونه سیمن قبل و بعداز درمان با گرده نخل در گروه کیس و همچنین نمونه سیمن گروه کنترل بر اساس دستور العمل WHO انالیز شده همچنین اندازه گیری free 8-Isoprostane و بیان ژنهای SOD- CAT-NRF2- GPX4 بررسی شد.
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    Infertile men aged 20 to 42 years were included in the study We excluded the case with these criteria from the research: history of genetic and systemic disorders, reproductive tract abnormality, testicular trauma, alcohol and substance abuse, and fertility medications at least for six months before participation.
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    مردان نابارور 20 تا 42 سال وارد مطالعه شدند معیارهای خروج: سابقه اختلالات ژنتیکی و سیستمیک ، ناهنجاری دستگاه تولید مثل ، ضربه بیضه ، سو مصرف الکل و مواد و داروهای باروری حداقل به مدت شش ماه قبل از شرکت.
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    In order to intervene in the case group, in addition to receiving standard infertility medication by a specialist physician, they also received 400 mg / kg palm pollen powder in gelatin capsules for two months.
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    جهت مداخله در گروه کیس علاوه بر دریافت درمان دارویی استاندارد ناباروریتوسط یک پزشک متخصص، به مدت دوماه 400mg/kg پودر گرده نخل در کپسول های ژلاتینی را نیز دریافت کردند.
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    Changes in sperm parameters Sex hormones and prolactin free 8-Isoprostane Expression of SOD-CAT-NRF2-GPX4 genes
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    تغییرات در پارامترهای اسپرم هورمونهای جنسی و پرولاکتین free 8-Isoprostane بیان ژنهای SOD- CAT-NRF2- GPX4
  • General information

    40
    42
    Not blinded
    Single blinded
    1
    Parallel
    Other
    2
    N/A
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    120
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    No
    No
    2015-03-22, 1394/01/02
    2016-03-21, 1395/01/02
    2015-09-23, 1394/07/01
    2017-09-23, 1396/07/01
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    2016-03-12, 1394/12/22
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    2017-06-11, 1396/03/21
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    2017-06-22, 1396/04/01
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    Increase the sample size
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    افزایش تعداد حجم نمونه ها
    Evaluation of the Antioxidant Role of Palm Pollen in Oligospermic and Asthenozoospermic Men and Its Correlation with Characteristics of Spermatozoa
    Antioxidant role of palm pollen in infertility
    بررسی نقش آنتی اکسیدانی گرده نخل در مردان اولیگواسپرمیک و استنواسپرمیک و ارتباط آن با ویژگیهای اسپرم
    نقش آنتی اکسیدانی گرده نخل در نابارور
    Normal anatomy of the genital area; Infertility due to oligo asthenospermia
    آناتومی نرمال ناحیه تناسلی؛ ناباروری به دلیل اولیگو و آستنواسپرمیا
    The case with the following criteria were excluded from the study: history of genetic and systemic disorders, reproductive tract abnormality, testicular trauma, alcohol and substance abuse, and fertility medications at least for six months before participation.
    سابقه اختلالات ژنتیکی و سیستمیک ، ناهنجاری دستگاه تولید مثل ، ضربه بیضه ، سو مصرف الکل و مواد و داروهای باروری حداقل به مدت شش ماه قبل از مشارکت.
    Participants entered the study after signing a personal and written consent form based on inclusion criteria. Their cement sample was measured before and after treatment with palm pollen capsule for two months in the case group and also the sample of the control group was measured according to the WHO 2010 analysis analysis guidelines. Also, the concentration of 8-Isoprostane, antioxidant genes was examined.
    شرکت کنندگان پس از امضا فرم رضایت شخصی و کتبی بر اساس معیارهای ورود وارد مطالعه شدند. نمونه سیمن انها قبل و بعد از درمان با کپسول گرده نخل به مدت دو ماه در گروه کیس و همچنین نمونه سیمن گروه کنترل بر اساس دستورالعمل انالیز سیمن WHO 2010 اندازه گیری شد. همچنین بررسی Concentration of 8-Isoprostane , ژنهای انتی اکسیدانی مورد بررسی قرار گرفت.
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    Simple randomization with sealed envelope
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    تصادفی سازی ساده با پاکت مهروموم شده تهیه شده
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    This study is a randomized, single-blind and comparative clinical trial including 60 cases of male infertility that was conducted during the year March to June 17, 2016. Palm pollen powder at a rate of 400 mg / kg in gelatin capsules was used for two consecutive months to treat eligible individuals.Have been received. The coding is done by one of the project partners and they are blind evaluators.
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    این تحقیق یک کارآزمایی بالینی تصادفی ، یک سو کور و مقایسه ای شامل 60 مورد مبتلا به ناباروری مردان است که در طی سال اسفند تا ۲۷ خرداد ۱۳۹۵ انجام شد. پودرگرده نخل به میزان 400 میلی گرم در کیلوگرم در کپسول های ژلاتینی به مدت دو ماه متوالی برای درمان افراد واجد شرایط مورد استفاده قرار گرفت.بیمار دارو را در پاکت های دربسته که کد بندی شده اند دریافت می کند. کد بندی توسط یکی از همکاران طرح صورت می گیرد و ارزیابی کننده کور می باشند.
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  • Primary outcomes

    #1
    10 months
    2 months
    10 ماه
    2 ماه
    RT-PCR and Semen analysis
    Semen analysis
    آزمایشات آنالیز سیمن و RT-PCR
    آزمایشات آنالیز سیمن
    #2
    10 months
    2 months
    10 ماه
    2 ماه
    RT-PCR and Semen analysis
    RT-PCR
    آزمایشات آنالیز سیمن و RT-PCR
    RT-PCR
  • Secondary outcomes

    #1
    Evaluation the levels of 8-Isoprostane and free radicals metabolites
    Semen samples were obtained twice from the case group, before and after treatment, and once from the control group through masturbation, masturbation and abstinence for three to five days. We then collected fresh semen samples in sterile plastic containers.
    ارزیابی میزان 8-ایزوپرستان و متابولیت های رادیکال های آزاد
    نمونه های مایع منی دو بار از گروه کیس ، قبل و بعد از دوره درمان و یک بار از گروه کنترل از طریق استمنا masturbation و سه تا پنج روز پرهیز جنسی به دست آمد. سپس نمونه های منی تازه را در ظروف پلاستیکی استریل جمع آوری کردیم.
    3 months after consumption of palm pollen
    2 months after consumption of palm pollen
    سه ماه بعد از مصرف گرده نخل
    دو ماه بعد از مصرف گرده نخل
    RT-PCR, molecular and biochemical tests
    The samples were exposed to 37 ° C for 30 minutes for liquefaction and semen analysis (fluid volume, pH, viscosity, sperm morphology, concentration and motility) was performed immediately according to the WHO guideline. Sex hormones were also examined using ELISA. In addition, in this clinical trial, a blind and comparative semen analysis was performed by a technician blindly.
    انجام آزمایشات مولکولی و بیوشیمیایی و RT-PCR
    نمونه ها در دمای 37 درجه سانتیگراد به مدت 30 دقیقه جهت مایع شدن قرار گرفتند و انالیز مایع منی (حجم مایع ، pH ، ویسکوزیته ، مورفولوژی اسپرم ، غلظت و تحرک) بلافاصله بر اساس گاید لاین WHO انجام شد. هورمونهای جنسی نیز با استفاده از الایزا مورد بررسی قرار گرفت. علاوه بر این ، در این کارآزمایی بالینی ، یک سوکور و مقایسه ای ، تجزیه و تحلیل منی توسط تکنسین بصورت کور انجام شد.
    #2
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    Measurement of antioxidant genes and 8- isoprene index
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    اندازه گیری ژنهای انتی اکسیدانی و شاخص 8- ایزوپرستان
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    After two months, receive palm pollen
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    بعداز دوماه دریافت گرده نخل
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    BSA-free Ham’s-F10 was used twice to wash the samples and then stored in RNALater solution (Qiagen: Germany) at -80 ° C until RNA extraction. Then, after extraction and PCR test, real-time test was performed on the samples.
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    برای شستن نمونه ها دو بار از محیط BSA-free Ham’s-F10 استفاده شد و سپس در محلول RNALater (Qiagen: Germany) در دمای 80- درجه سانتیگراد تا زمان استخراج RNA ذخیره شد. سپس بعد از استخراج و انجام تست پی سی ار برای نمونه ها تست ریل تایم انجام گرفت.
  • Intervention groups

    #1
    Control group: They are received only the standard male infertility drug prescribed by Urologists.
    In addition to standard treatment by a urologist, the case group received 400 mg / kg of palm pollen powder in gelatin capsules for two months.
    گروه کنترل: تنها درمان استاندارد ناباروری را توسط متخصص ارولوژی دریافت می کنند.
    افراد گروه کیس علاوه بر درمان استاندارد توسط متخصص ارولوژی ، 400mg/kg پودر گرده نخل در کپسول های ژلاتینی را به مدت دو ماه دریافت کردند.
    #2
    Treatment - Drugs
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    Case group: They are received 4 gram palm pollen as 1 gram Mogza capsules (two capsules in the morning and two capsules at night, one hour after meal) in addition to standard male infertility drug prescribed by Urologist.
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    گروه مداخله: درمان استاندارد ناباروری را توسط متخصص ارولوژی دریافت می کنند و به طور همزمان از گرده نخل به میزان 4 گرم در روز به صورت کپسولهای یک گرمی مگزا (دو کپسول صبح و دو کپسول شب، یک ساعت بعد از غذا) استفاده می کنند.
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  • Recruitment centers

    #1
    Name of recruitment center - English: Research Center for Molecular Medicine of Shahid Mohammadi Hospital
    Name of recruitment center - Persian: مرکز تحقیقات پزشکی مولکولی بیمارستان شهیدمحمدی
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Street address - English: Laboratory of Molecular Medicine, Ground Floor, Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
    Street address - Persian: بندرعباس، بلوار جمهوری اسلامی، بیمارستان شهید محمدی، ضلع شرقی بیمارستان، معاونت پژوهشی، طبقه همکف، ازمایشگاه پزشکی مولکولی
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Fertility and infertility center Om-e-Leila
    Name of recruitment center - Persian: مرکز باروری و ناباروی ام لیلا
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Street address - English: Bandar Abbas, Om-e-Leila Hospital
    Street address - Persian: بندرعباس، بیمارستان ام لیلا
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 7915868462
    Phone: +98 76 3333 7192
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: Oom Leila IVF Center
    Name of recruitment center - Persian: مرکز IVF ام لیلا
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Street address - English: Oom Leila Hospital, Behind Seyyed Mozaffar Shine, Jomhouri Eslami Blv, Bandar Abbas
    Street address - Persian: بندرعیاس، بلوار جمهوری اسلامی،پشت زیارتگاه سید مظفر، بیمارستان ام لیلا
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Hormozgan University of Medical Sciences
    Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر عبدالعظیم نجاتی زاده
    Street address - English: Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
    Street address - Persian: بندرعباس، بلوار جمهوری اسلامی، بیمارستان شهید محمدی، ضلع شرقی بیمارستان، معاونت تحقیقات و فناوری
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Najati Zadeh
    Full name of responsible person - Persian: دکتر نجاتی زاده
    Street address - English: Jomhory Boulevard, Shahid Mohammadi Hospital - Vice Chancellor for Research, Reproduction and Infertility Research Center
    Street address - Persian: بلوار جمهوری، بیمارستان شهید محمدی- معاونت تحقیقات، مرکز تحقیقات باروری و ناباروری
    City - English: Bandarabbass
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 7915868462
    Phone: +98 76 3333 7192
    Fax:
    Email: fallahi.leila@gmail.com
    Web page address:
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    Vice chancellor for research, Hormozgan University of Medical Sciences
    Bandare-abbas University of Medical Sciences
    معاونت تحقیقات و فناوری دانشگاه علوم پزشکی هرمزگان
    دانشگاه علوم پزشکی بندرعباس
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Research Center for Molecular Medicine of Shahid Mohammadi Hospital
    Name of organization / entity - Persian: مرکز تحقیقات پزشکی مولکولی بیمارستان شهیدمحمدی
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: PhD Student Research of Molecular Medicine
    Position - Persian: دانشجوی دکترای تخصصی پژوهشی پزشکی مولکولی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Laboratory of Molecular Medicine, Ground Floor, Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
    Street address - Persian: بندرعباس، بلوار جمهوری اسلامی، بیمارستان شهید محمدی، ضلع شرقی بیمارستان، معاونت پژوهشی ، طبقه همکف، ازمایشگاه پزشکی مولکولی
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: fertility and infertility Research Center of Shahid Mohammadi Hospital, Bandar Abbas, Iran
    Name of organization / entity - Persian: مرکز تحقیقات باروری و ناباروری بیمارستان شهیدمحمدی- بندرعباس، ایران
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: PhD Student Research of Reproductive biology
    Position - Persian: دانشجوی دکترای تخصصی پژوهشی بیولوژی تولید مثل
    Latest degree: phd
    Area of specialty/work: 22
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kamarbandi St., Islamic Republic Boulevard, Shahid Mohammadi Hospital, fertility and Infertility Research Center, Bandar Abbas, Iran
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، بلوار جمهوری اسلامی،خیابان کمربندی ،مرکز تحقیقات باروری و ناباروری
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Research Center for Molecular Medicine of Shahid Mohammadi Hospital
    Name of organization / entity - Persian: مرکز تحقیقات پزشکی مولکولی بیمارستان شهید محمدی
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: PhD Student of Research in Molecular Medicine
    Position - Persian: دانشجوی دکترای تخصصی پژوهشی پزشکی مولکولی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Laboratory of Molecular Medicine, Ground Floor, Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
    Street address - Persian: بندرعباس، بلوار جمهوری اسلامی، بیمارستان شهید محمدی، ضلع شرقی بیمارستان، معاونت پژوهشی ، طبقه همکف، ازمایشگاه پزشکی مولکولی
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: fertility and infertility Research Center Shahid Mohammadi Hospital,Bandar Abbas
    Name of organization / entity - Persian: مرکز تحقیقات باروری و ناباروری بیمارستان شهید محمدی- بندرعباس
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: PhD Student of Research Reproductive biology
    Position - Persian: دانشجوی دکترای تخصصی پژوهشی بیولوژی تولید مثل
    Latest degree: phd
    Area of specialty/work: 22
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kamarbandi St., Islamic Republic Boulevard, Shahid Mohammadi Hospital, fertility and Infertility Research Center, Bandar Abbas, Iran
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، بلوار جمهوری اسلامی،خیابان کمربندی ،مرکز تحقیقات باروری و ناباروری
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Research Center for Molecular Medicine of Shahid Mohammadi Hospital
    Name of organization / entity - Persian: مرکز تحقیقات پزشکی مولکولی بیمارستان شهیدمحمدی
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: PhD Student of Research in Molecular Medicine
    Position - Persian: دانشجوی دکترای تخصصی پژوهشی پزشکی مولکولی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Laboratory of Molecular Medicine, Ground Floor, Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
    Street address - Persian: بندرعباس، بلوار جمهوری اسلامی، بیمارستان شهید محمدی، ضلع شرقی بیمارستان، معاونت پژوهشی ، طبقه همکف، ازمایشگاه پزشکی مولکولی
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Fertility and infertility research center shahid Mohammadi Hospital
    Name of organization / entity - Persian: مرکز تحقیقات باروری و ناباروری بیمارستان شهیدمحمدی
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: PhD Student of Research in Molecular Medicine
    Position - Persian: دانشجوی دکترای تخصصی پژوهشی بیولوژی تولید مثل
    Latest degree: phd
    Area of specialty/work: 22
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kamarbandi St., Islamic Republic Boulevard, Shahid Mohammadi Hospital, fertility and Infertility Research Center, Bandar Abbas, Iran
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، بلوار جمهوری اسلامی،خیابان کمربندی ،مرکز تحقیقات باروری و ناباروری
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:
  • Sharing plan

    yes
    no
    no
    no
    yes
    no
    no
    empty
    Abstract and original article after publication
    empty
    خلاصه و اصل مقاله بعداز چاپ
    empty
    two months
    empty
    دو ماه
    empty
    researchers
    empty
    محققین
    empty
    To conduct scientific research
    empty
    جهت انجام تحقیقات علمی
    empty
    To the clinical trial site
    empty
    به سایت کارازمایی بالینی
    empty
    Email - Call - SMS
    empty
    ایمیل - تماس- پیامک
    empty
    -
    empty
    -

Protocol summary

Study aim
The aim of this study was to investigate: The effect of palm pollen on sexual parameters As well as the expression of antioxidant genes Sex hormones in infertile men
Design
single-blind, and comparative clinical trial
Settings and conduct
This study was conducted during 2015. Palm pollen at a dose of 400 mg / kg in gelatin capsules was used for two consecutive months to treat eligible individuals. The control group was selected. Semen samples were analyzed before and after palm pollen treatment in the case group and also semen samples in the control group according to WHO guidelines.
Participants/Inclusion and exclusion criteria
Infertile men aged 20 to 42 years were included in the study We excluded the case with these criteria from the research: history of genetic and systemic disorders, reproductive tract abnormality, testicular trauma, alcohol and substance abuse, and fertility medications at least for six months before participation.
Intervention groups
In order to intervene in the case group, in addition to receiving standard infertility medication by a specialist physician, they also received 400 mg / kg palm pollen powder in gelatin capsules for two months.
Main outcome variables
Changes in sperm parameters Sex hormones and prolactin free 8-Isoprostane Expression of SOD-CAT-NRF2-GPX4 genes

General information

Reason for update
Increase the sample size
Acronym
IRCT registration information
IRCT registration number: IRCT2015020120895N2
Registration date: 2015-10-12, 1394/07/20
Registration timing: prospective

Last update: 2021-05-03, 1400/02/13
Update count: 1
Registration date
2015-10-12, 1394/07/20
Registrant information
Name
Soghra Fallahi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 7192
Email address
lfallahi@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hormozgan University of Medical Sciences
Expected recruitment start date
2016-03-21, 1395/01/02
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
2016-03-12, 1394/12/22
Actual recruitment end date
2017-06-11, 1396/03/21
Trial completion date
2017-06-22, 1396/04/01
Scientific title
Evaluation of the Antioxidant Role of Palm Pollen in Oligospermic and Asthenozoospermic Men and Its Correlation with Count, Motility and Morphology of the Sperm
Public title
Antioxidant role of palm pollen in infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal anatomy of the genital area; Infertility due to oligo asthenospermia
Exclusion criteria:
The case with the following criteria were excluded from the study: history of genetic and systemic disorders, reproductive tract abnormality, testicular trauma, alcohol and substance abuse, and fertility medications at least for six months before participation.
Age
From 20 years old to 42 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 120
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with sealed envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a randomized, single-blind and comparative clinical trial including 60 cases of male infertility that was conducted during the year March to June 17, 2016. Palm pollen powder at a rate of 400 mg / kg in gelatin capsules was used for two consecutive months to treat eligible individuals.Have been received. The coding is done by one of the project partners and they are blind evaluators.
Placebo
Not used
Assignment
Other
Other design features
Participants entered the study after signing a personal and written consent form based on inclusion criteria. Their cement sample was measured before and after treatment with palm pollen capsule for two months in the case group and also the sample of the control group was measured according to the WHO 2010 analysis analysis guidelines. Also, the concentration of 8-Isoprostane, antioxidant genes was examined.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Molecular Medicine Research Center
Street address
Laboratory of Molecular Medicine, Ground Floor, Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7915915517
Approval date
2015-02-23, 1393/12/04
Ethics committee reference number
HEC-93-12-4

Health conditions studied

1

Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Azoospermia NOS Oligospermia NOS

Primary outcomes

1

Description
Evaluation of count, motility and morphology of sperm
Timepoint
2 months
Method of measurement
Semen analysis

2

Description
Evaluation of expression of antioxidant SOD, CAT, GPX, NRF2 and KEAP1 genes
Timepoint
2 months
Method of measurement
RT-PCR

Secondary outcomes

1

Description
Semen samples were obtained twice from the case group, before and after treatment, and once from the control group through masturbation, masturbation and abstinence for three to five days. We then collected fresh semen samples in sterile plastic containers.
Timepoint
2 months after consumption of palm pollen
Method of measurement
The samples were exposed to 37 ° C for 30 minutes for liquefaction and semen analysis (fluid volume, pH, viscosity, sperm morphology, concentration and motility) was performed immediately according to the WHO guideline. Sex hormones were also examined using ELISA. In addition, in this clinical trial, a blind and comparative semen analysis was performed by a technician blindly.

2

Description
Measurement of antioxidant genes and 8- isoprene index
Timepoint
After two months, receive palm pollen
Method of measurement
BSA-free Ham’s-F10 was used twice to wash the samples and then stored in RNALater solution (Qiagen: Germany) at -80 ° C until RNA extraction. Then, after extraction and PCR test, real-time test was performed on the samples.

Intervention groups

1

Description
In addition to standard treatment by a urologist, the case group received 400 mg / kg of palm pollen powder in gelatin capsules for two months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fertility and infertility center Om-e-Leila
Full name of responsible person
Dr Soghra Fallahi
Street address
Bandar Abbas, Om-e-Leila Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7915868462
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Najati Zadeh
Street address
Jomhory Boulevard, Shahid Mohammadi Hospital - Vice Chancellor for Research, Reproduction and Infertility Research Center
City
Bandarabbass
Province
Hormozgan
Postal code
7915868462
Phone
+98 76 3333 7192
Fax
Email
fallahi.leila@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
fertility and infertility Research Center of Shahid Mohammadi Hospital, Bandar Abbas, Iran
Full name of responsible person
Dr Soghra Fallahi
Position
PhD Student Research of Reproductive biology
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Kamarbandi St., Islamic Republic Boulevard, Shahid Mohammadi Hospital, fertility and Infertility Research Center, Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7915915517
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
fertility and infertility Research Center Shahid Mohammadi Hospital,Bandar Abbas
Full name of responsible person
Dr Soghra Fallahi
Position
PhD Student of Research Reproductive biology
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Kamarbandi St., Islamic Republic Boulevard, Shahid Mohammadi Hospital, fertility and Infertility Research Center, Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7915915517
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fertility and infertility research center shahid Mohammadi Hospital
Full name of responsible person
Dr Soghra Fallahi
Position
PhD Student of Research in Molecular Medicine
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Kamarbandi St., Islamic Republic Boulevard, Shahid Mohammadi Hospital, fertility and Infertility Research Center, Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7915915517
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Abstract and original article after publication
When the data will become available and for how long
two months
To whom data/document is available
researchers
Under which criteria data/document could be used
To conduct scientific research
From where data/document is obtainable
To the clinical trial site
What processes are involved for a request to access data/document
Email - Call - SMS
Comments
-
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