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Comparison of letrozole and clomiphen in mild protocol among infertile poor responders

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History
# Registration date Revision Id
4 2021-08-30, 1400/06/08 196777
3 2021-03-16, 1399/12/26 175742
2 2021-03-04, 1399/12/14 174236
1 2011-08-10, 1390/05/19 6861
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  • Protocol summary

    Poor ovarian response to controlled ovarian stimulation (COS) is still an important interest in assisted reproduction. To compare the effect of two protocols for mild ovarian stimulation on assisted reproductive technology (ART) outcomes in poor responders, in a randomized control study, 184 poor responder women who candidate for ART will randomly assign to two groups. In group I, women receive clomiphen/gonadotropin/antagonist protocol, and implantation; chemical and clinical pregnancy rate will compare with those of women in group II who give letrozole / gonadotropin / antagonist protocol.
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    پاسخ ضعيف به تحريك تخمدان در بيماران كانديد روشهاي باروري كمك شده بسيار حائز اهميت است و در حال حاضر هيچ پروتوكل دارويي تثبيت شده اي جهت اين بيماران وجود ندارد. لذا در يك مطالعه كارآزمايي باليني تصادفي تك مركزي 184 بيمار زن با پاسخ ضعيف تخمدان كه كانديد انجام باروري كمك شده هستند انتخاب مي شوند. اين بيماران به دو گروه مساوي تقسيم مي شوند. در گروه اول بيماران كلوميفن/گونادوتروپين/آنتاگونيست دريافت مي كنند و از نظر ميزان لانه گزيني ، حاملگي شيميايي و كلينيكي با گروه دوم كه لتروزول/گونادوتروپين/آنتاگونيست مقايسه مي شوند.
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    The aim of present study was to compare the efficacy of letrozole and clomiphene citrate for mild ovarian stimulation on ART outcomes in poor responder women.
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    هدف از مطالعه حاضر مقایسه اثر لتروزول و کلومیفن سیترات برای تحریک خفیف تخمدان بر نتایج ART در زنان پاسخ دهنده ضعیف بود.
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    phase 2 of clinical trial. a computer-generated list of random numbers was used for patient classification
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    مرحله 2 آزمایش بالینی. از لیست رایانه ای اعداد تصادفی برای طبقه بندی بیماران استفاده شد.
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    It is a randomized clinical trial, No blinding. Yazd Infertility Research Center was conducted.
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    کارآزمایی بالینی تصادفی بدون کورسازی است.در مرکز تحقیقات ناباروری یزد انجام شد.
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    women included in this study who had one or more previous failed ART cycle in which three or fewer oocytes were been retrieved and had serum E2 levels ≤500 pg/ml on the day of hCG administration. The exclusion criteria were: ٔBMI> 30 kg/m2 ,Endocrine or metabolic disorders,History of ovarian surgery ,Severe endometriosis,Azoospermia in male partner ,FSH >15 m IU/ml
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    خانمهایی در این مطالعه وارد شدند که یک یا چند چرخه ART شکست خورده قبلی داشت که در آن سه یا کمتر تخمک بازیابی شده بود و سطح استرادیول سرم کمتر از500 pg / ml در روز تجویز hCG بود. معیارهای خروج: BMI> 30 کیلوگرم در مترمربع ، اختلالات غدد درون ریز یا متابولیک ، سابقه جراحی تخمدان، آندومتریوز شدید ، آزواسپرمی مرد ، FSH> 15m IU / ml
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    All women received oral contraceptive for 21 days which started on the first day of previous cycle. In group I, stimulation was started by administration of clomiphene citrate 100 mg daily from day 3 of menstruation cycle until day 7 of the cycle. Patients in group II received letrozole from day 3 of the cycle 5mg /day for 5 days. In both groups, gonadotropins stimulation with hMG 225-300 IU daily was started from day 5 of cycle. Patient was monitored by serial vaginal ultrasonography and measurement of serum E2 levels.As the dominant follicle reached to 14mm in mean diameter, 0.25 mg/day GnRH antagonist . When at least two follicles with a mean diameter of 18 mm were observed, 10000 IU hCG (Pregnyl, Organon, Netherlands) was administrated.
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    همه خانمها به مدت 21 روز که از روز اول چرخه قبلی شروع شده است ، قرص پیشگیری از بارداری خوراکی دریافت کردند. در گروه I ، تحریک با استفاده از کلومیفن سیترات 100 میلی گرم در روز از روز 3 چرخه قاعدگی تا روز 7 چرخه شروع شد. بیماران در گروه II از روز 3 سیکل 5 میلی گرم در روز به مدت 5 روز لتروزول دریافت کردند. در هر دو گروه ، تحریک گنادوتروپین ها با hMG 225-300 واحد روزانه از روز 5 چرخه شروع شد. بیمار با سونوگرافی سریال واژن و اندازه گیری سطح E2 سرم کنترل شد.با رسیدن فولیکول غالب به قطر 14 میلی متر ، 0.25 میلی گرم در روز آنتاگونیست GnRH شروع شد. هنگامی که حداقل دو فولیکول با قطر متوسط 18 میلی متر مشاهده شد تجویز شد.
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    Chemical pregnancy was defined by positive β-hCG, 12 days after embryos transfer. Clinical pregnancy was identified as observation of fetal heart activity by transvaginal ultrasonography.
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    بارداری شیمیایی با β-hCG مثبت ، 12 روز پس از انتقال جنین تعریف شد. حاملگی بالینی به عنوان مشاهده فعالیت قلب جنین توسط سونوگرافی از طریق واژن مشخص شد.

  • General information

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    184
    2011-08-01, 1390/05/10
    2009-01-01, 1387/10/12
    2012-08-01, 1391/05/11
    2011-08-01, 1390/05/10
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    2009-03-01, 1387/12/11
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    2011-01-01, 1389/10/11
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    2011-10-30, 1390/08/08
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    Updating the trial according to the last changes in methods and adding results
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    به روز رسانی کارازمایی بالینی بر اساس آخرین تغییرات و اضافه کردن نتایج
    three or fewer oocytes were been retrieved in previous failed ART cycle; serum E2 levels ≤ 500 pg/ml on the day of hCG administration.
    اشتن سه يا كمتر اووسيت در سيكلهاي ناموفق قبلي؛ داشتن سطح سرمي استراديول كمتر يا مساوي 500 پيكوگرم در ميلي ليتر در روز تزريق هاچ سي جي
    BMI >30 mg/m2; endocrine or metabolic disorders; history of ovarian surgery; severe endometriosis; azoospermia in male partner.
    FSH >15 m IU/ml
    شاخص توده بدني بالاي 30؛اختلالات اندوكرين و متابوليك؛سابقه جراحي تخمدان؛اندومتريوز شديد؛ازواسپرمي در همسر بيمار
    FSH >15 m IU/ml
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    Randomization by table of random numbers
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    تصادفی سازی با استفاده از جدول اعداد تصادفی
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  • Secondary outcomes

    #1
    Endometrial thickness
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    ضخامت اندومتر
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    on the day of the hCG administration
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    روز تزريق هاچ سي جي
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    ultrasonography
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    مشاهده در سونوگرافي
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  • Recruitment centers

    #1
    Name of recruitment center - English: Research and Clinical Center for Infertility
    Name of recruitment center - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Street address - English:
    Street address - Persian:
    City - English: Yazd
    City - Persian: يزد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Research and Clinical Center for Infertility
    Name of recruitment center - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مریم افتخار
    Street address - English: Bouali Ave
    Street address - Persian: خیابان بوعلی
    City - English: Yazd
    City - Persian: يزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916977443
    Phone: +98 35 3824 7085
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Research and Clinical Center for Infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English: Robab Davar
    Full name of responsible person - Persian: دكتر رباب داور
    Street address - English: Safaeiyeh, Bouali Ave
    Street address - Persian: صفاييه -خيابان بوعلي
    City - English: Yazd
    City - Persian: يزد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: shahid sadoughi university of medical science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید صدوقی
    Full name of responsible person - English: masood mirzaee
    Full name of responsible person - Persian: مسعود میرزایی
    Street address - English: bahonar Ave
    Street address - Persian: خیابان باهنر
    City - English: Yazd
    City - Persian: يزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3726 3733
    Fax:
    Email: masoud_mirzaei@hotmail.com
    Web page address:
    empty
    Public
    empty
    Domestic
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    Academic
    Research and Clinical Center for Infertility
    shahid sadoughi university of medical science
    مركز تحقيقاتي و درماني ناباروري يزد
    دانشگاه علوم پزشکی شهید صدوقی

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Research and Clinical Center for Infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مريم افتخار
    Position - English: Reserch faculty member
    Position - Persian: هيئت علمي پ‍ژوهشي
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Safaeiyeh, Bouali Ave
    Street address - Persian: صفاييه - خيابان بوعلي
    City - English: Yazd
    City - Persian: يزد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 35 1824 7085
    Mobile:
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Research and Clinical Center for Infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مريم افتخار
    Position - English: Reserch faculty member
    Position - Persian: هيئت علمي پ‍ژوهشي
    Latest degree: med_doctor
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Safaeiyeh, Bouali Ave
    Street address - Persian: صفاييه - خيابان بوعلي
    City - English: Yazd
    City - Persian: يزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916977443
    Phone: +98 35 1824 7085
    Mobile: +98 913 156 3078
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Research and Clinical Center for Infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مريم افتخار
    Position - English: Gynecologist/MD
    Position - Persian: تخصص 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: Safaeiyeh, Bouali Ave
    Street address - Persian: صفاييه- خيابان بوعلي
    City - English: Yazd
    City - Persian: يزد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 35 1824 7085
    Mobile:
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Research and Clinical Center for Infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مريم افتخار
    Position - English: Gynecologist/MD
    Position - Persian: تخصص زنان و زايمان
    Latest degree: med_doctor
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Safaeiyeh, Bouali Ave
    Street address - Persian: صفاييه- خيابان بوعلي
    City - English: Yazd
    City - Persian: يزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 1824 7085
    Mobile: +98 913 156 3078
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Maryam eftekhar
    Full name of responsible person - Persian: مریم افتخار
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: med_doctor
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Yazd Yazd Infertility Research Center, Bouali Street
    Street address - Persian: مرکز تحقیقات ناباروری یزد خیابان بوعلی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916977443
    Phone: +98 35 3824 7085
    Mobile: +98 913 156 3078
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:

  • Sharing plan

    yes
    yes
    yes
    yes
    yes
    yes
    yes
    empty
    All participant data sets are to be shared
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    کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
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    2 months after the result publication
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    2 ماه بعد از چاپ نتایج
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    A journal in which the results are published
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    ژورنال چاپ کننده نتایج
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    Submission of an official application via the agent that is legally in charge
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    درخواست رسمی از طریق مرجع قانونی
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    Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran
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    پژوهشکده علوم تولید مثل یزد، خیابان بوعلی، یزد، ایران
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    Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.
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    درخواست از معاونت پژوهشی ، مطرح شدن در شورای پژوهشی مرکز ناباروری ،درصورت قبول درخواست ارجاع به حراست مرکز و تکمیل فرمهای مربوطه، ارجاع به کارشناس پژوهشی و دریافت داده ها

  • Trial results

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    Yes
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    2021-03-07, 1399/12/17
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    2014-11-15, 1393/08/24

    Baseline characteristics of the patients in both groups

    Variable Clomiphene group (n=80) Letrozole group (n=87) p-values
    Mean age (years) 37.37 ± 4.36 37.22 ± 3.95 0.807
    BMI (kg/m2) 24.56 ± 2.53 25.2 ± 2.34 0.099
    Infertility duration (years) 9.17 ± 6.53 7.93 ± 4.70 0.169
    Basal FSH level (mIU/mL) 8.95 ± 4.08 8.70 ±4.20 0.705
    Number of previous failed failing IVF/ICSI cycles 2.53 ± 1.12 2.16 ±0.44 0.431
    Duration of hormonal stimulation (days) 11.22 ± 1.39 11.35 ± 1.23 0.520
    Total number of hMG ampoules (IU) 29.60 ± 9.07 29.27 ± 9.78 0.825
    E2 level on the day of hCG (pg/mL) 978.46 ± 614.99 1131.83 ± 677.73 0.216
    Endometrial thickness (mm) 8.39 ± 0.38 9.16 ± 1.24 0.000
    Number of oocyte retrieved 3.97 ± 3.18 4.25 ± 2.84 0.553
    Number of embryo obtained 2.50 ± 2.04 2.31 ± 1.10 0.452
    Number of embryo transferred 2.01 ± 0.92 2.00 ± 0.83 0.927

    Outcome of IVF/ICSI-ET treatment cycles in both groups

    Variable Clomiphene group (n=80) Letrozole group (n=87) p-value
    Fertilization rate (%) 58.74% 62.6% 0.482
    Implantation rate (%) 6.6% 7.2% 0.024
    Chemical pregnancy rate a n, (%) 10.87 (11.5%) 11.80 (13.8%) 0.816
    Clinical pregnancy rate b n, (%) 7 (8%) 9 (11.3%) 0.601
    Miscarriage rate c n, (%) (30%) (27.3%) 1.00

    chi-square test was use.

    P ≤0.05 was considered statistically significant

    a: Chemical pregnancy per cycle b: Clinical pregnancy per cycle c: Miscarriage rate per pregnancy

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    Abstract Background: Poor ovarian response to controlled ovarian stimulation is one of the most important interest points in assisted reproduction. Mild ovarian stimulation seems to be preferable to high dose of FSH regimens in women with a history of poor ovarian response in previous protocol. Clomiphene citrate and letrozole alone or in combination with FSH have been used in mild ovarian stimulation protocol. Objective: To compare the efficacy of letrozole and clomiphene citrate for mild ovarian stimulation on assisted reproductive technology outcomes in poor responders. Materials and Methods: In a randomized control study, 184 women aged between 20 and 45 years with the history of poor response to ovarian stimulation who were candidate for ART were randomly subdivided into two groups: group I (n= 80), women who underwent the clomiphene/gonadotropin/antagonist protocol; and group II (n= 87), patients who underwent the letrozole/gonadotropin/antagonist protocol. Groups were compared regarding implantation, chemical and clinical pregnancy rates. Results: There was a significant difference in the mean endometrial thickness between two groups (9.16±1.2 mm vs. 8.3±0.3 mm). The implantation rate was significantly higher in letrozole group compare to clomiphene group (7.2 vs. 6.6%, p=0.024 respectively). No significant differences were found in chemical and clinical pregnancy rate between two groups. Conclusion: In mild ovarian stimulation protocol, letrozole and clomiphene have similar value for the poor responder. The optimal treatment strategy for these patients remains debated.

Protocol summary

Study aim
The aim of present study was to compare the efficacy of letrozole and clomiphene citrate for mild ovarian stimulation on ART outcomes in poor responder women.
Design
phase 2 of clinical trial. a computer-generated list of random numbers was used for patient classification
Settings and conduct
It is a randomized clinical trial, No blinding. Yazd Infertility Research Center was conducted.
Participants/Inclusion and exclusion criteria
women included in this study who had one or more previous failed ART cycle in which three or fewer oocytes were been retrieved and had serum E2 levels ≤500 pg/ml on the day of hCG administration. The exclusion criteria were: ٔBMI> 30 kg/m2 ,Endocrine or metabolic disorders,History of ovarian surgery ,Severe endometriosis,Azoospermia in male partner ,FSH >15 m IU/ml
Intervention groups
All women received oral contraceptive for 21 days which started on the first day of previous cycle. In group I, stimulation was started by administration of clomiphene citrate 100 mg daily from day 3 of menstruation cycle until day 7 of the cycle. Patients in group II received letrozole from day 3 of the cycle 5mg /day for 5 days. In both groups, gonadotropins stimulation with hMG 225-300 IU daily was started from day 5 of cycle. Patient was monitored by serial vaginal ultrasonography and measurement of serum E2 levels.As the dominant follicle reached to 14mm in mean diameter, 0.25 mg/day GnRH antagonist . When at least two follicles with a mean diameter of 18 mm were observed, 10000 IU hCG (Pregnyl, Organon, Netherlands) was administrated.
Main outcome variables
Chemical pregnancy was defined by positive β-hCG, 12 days after embryos transfer. Clinical pregnancy was identified as observation of fetal heart activity by transvaginal ultrasonography.

General information

Reason for update
Updating the trial according to the last changes in methods and adding results
Acronym
IRCT registration information
IRCT registration number: IRCT201107146420N3
Registration date: 2011-08-10, 1390/05/19
Registration timing: retrospective

Last update: 2021-03-07, 1399/12/17
Update count: 3
Registration date
2011-08-10, 1390/05/19
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Clinical Center for infertility, Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2011-08-01, 1390/05/10
Actual recruitment start date
2009-03-01, 1387/12/11
Actual recruitment end date
2011-01-01, 1389/10/11
Trial completion date
2011-10-30, 1390/08/08
Scientific title
Comparison of letrozole and clomiphen in mild protocol among infertile poor responders
Public title
Comparison of letrozole and clomiphen in mild protocol among infertile poor responders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
three or fewer oocytes were been retrieved in previous failed ART cycle; serum E2 levels ≤ 500 pg/ml on the day of hCG administration.
Exclusion criteria:
BMI >30 mg/m2; endocrine or metabolic disorders; history of ovarian surgery; severe endometriosis; azoospermia in male partner. FSH >15 m IU/ml
Age
From 20 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 184
Actual sample size reached: 184
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by table of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd Research and Clinical Center for infertility, Shahid Sadoughi University of
Street address
Bouali Ave, Safaeiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
1990-12-01, 1369/09/10
Ethics committee reference number
13/1389

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N70-N77
ICD-10 code description
Inflammatory diseases of female pelvic organs

Primary outcomes

1

Description
chemical pregnancy
Timepoint
12 day after embryo transfer
Method of measurement
beta hCG blood test

2

Description
clinical pregnancy
Timepoint
3 weeks after chemical pregnancy
Method of measurement
observation of fetal heart activity by transvaginal ultrasonography

3

Description
implantation rate
Timepoint
3 weeks after chemical pregnancy
Method of measurement
the ratio of the number of embryonic sacs diagnosed by sonography to the total number of the embryos transferred

Secondary outcomes

empty

Intervention groups

1

Description
group I: clomiphen citrate 50 mg twice a day from 3th day of menstruation cycle until 7th day of the cycle.
Category
Treatment - Drugs

2

Description
group II: letrozole 2.5 mg twice a day from 3th of the cycle until 8th day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Street address
Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 3824 7085
Email
eftekhar@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
shahid sadoughi university of medical science
Full name of responsible person
masood mirzaee
Street address
bahonar Ave
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
masoud_mirzaei@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahid sadoughi university of medical science
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
Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Position
Reserch faculty member
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Safaeiyeh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Position
Gynecologist/MD
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Safaeiyeh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam eftekhar
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd Yazd Infertility Research Center, Bouali Street
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 3824 7085
Email
eftekhar@ssu.ac.ir

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
All participant data sets are to be shared
When the data will become available and for how long
2 months after the result publication
To whom data/document is available
A journal in which the results are published
Under which criteria data/document could be used
Submission of an official application via the agent that is legally in charge
From where data/document is obtainable
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran
What processes are involved for a request to access data/document
Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.
Comments

Trial results

Please tick if results have been published
Yes
Summary result posting date
2021-03-07, 1399/12/17
Table of baseline comparison

Baseline characteristics of the patients in both groups

Variable Clomiphene group (n=80) Letrozole group (n=87) p-values
Mean age (years) 37.37 ± 4.36 37.22 ± 3.95 0.807
BMI (kg/m2) 24.56 ± 2.53 25.2 ± 2.34 0.099
Infertility duration (years) 9.17 ± 6.53 7.93 ± 4.70 0.169
Basal FSH level (mIU/mL) 8.95 ± 4.08 8.70 ±4.20 0.705
Number of previous failed failing IVF/ICSI cycles 2.53 ± 1.12 2.16 ±0.44 0.431
Duration of hormonal stimulation (days) 11.22 ± 1.39 11.35 ± 1.23 0.520
Total number of hMG ampoules (IU) 29.60 ± 9.07 29.27 ± 9.78 0.825
E2 level on the day of hCG (pg/mL) 978.46 ± 614.99 1131.83 ± 677.73 0.216
Endometrial thickness (mm) 8.39 ± 0.38 9.16 ± 1.24 0.000
Number of oocyte retrieved 3.97 ± 3.18 4.25 ± 2.84 0.553
Number of embryo obtained 2.50 ± 2.04 2.31 ± 1.10 0.452
Number of embryo transferred 2.01 ± 0.92 2.00 ± 0.83 0.927

Participant flow diagram
Table of variable outcomes' results

Outcome of IVF/ICSI-ET treatment cycles in both groups

Variable Clomiphene group (n=80) Letrozole group (n=87) p-value
Fertilization rate (%) 58.74% 62.6% 0.482
Implantation rate (%) 6.6% 7.2% 0.024
Chemical pregnancy rate a n, (%) 10.87 (11.5%) 11.80 (13.8%) 0.816
Clinical pregnancy rate b n, (%) 7 (8%) 9 (11.3%) 0.601
Miscarriage rate c n, (%) (30%) (27.3%) 1.00

chi-square test was use.

P ≤0.05 was considered statistically significant

a: Chemical pregnancy per cycle b: Clinical pregnancy per cycle c: Miscarriage rate per pregnancy

Table of adverse events
First publication date
2014-11-15, 1393/08/24
Abstract of published paper
Abstract Background: Poor ovarian response to controlled ovarian stimulation is one of the most important interest points in assisted reproduction. Mild ovarian stimulation seems to be preferable to high dose of FSH regimens in women with a history of poor ovarian response in previous protocol. Clomiphene citrate and letrozole alone or in combination with FSH have been used in mild ovarian stimulation protocol. Objective: To compare the efficacy of letrozole and clomiphene citrate for mild ovarian stimulation on assisted reproductive technology outcomes in poor responders. Materials and Methods: In a randomized control study, 184 women aged between 20 and 45 years with the history of poor response to ovarian stimulation who were candidate for ART were randomly subdivided into two groups: group I (n= 80), women who underwent the clomiphene/gonadotropin/antagonist protocol; and group II (n= 87), patients who underwent the letrozole/gonadotropin/antagonist protocol. Groups were compared regarding implantation, chemical and clinical pregnancy rates. Results: There was a significant difference in the mean endometrial thickness between two groups (9.16±1.2 mm vs. 8.3±0.3 mm). The implantation rate was significantly higher in letrozole group compare to clomiphene group (7.2 vs. 6.6%, p=0.024 respectively). No significant differences were found in chemical and clinical pregnancy rate between two groups. Conclusion: In mild ovarian stimulation protocol, letrozole and clomiphene have similar value for the poor responder. The optimal treatment strategy for these patients remains debated.
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