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General information
empty
Updating the trial according to the last changes in methods and adding results
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
به روز رسانی کارازمایی بالینی بر اساس آخرین تغییرات و اضافه کردن نتایج
Secondary outcomes
#1
Miscarriage rate
empty
Miscarriage rate
ميزان سقط
empty
ميزان سقط
20 weeks after intervention
empty
20 weeks after intervention
20 هفته بعد از مداخله
empty
20 هفته بعد از مداخله
Absence of fetal heart activity in ultra sound sonography
empty
Absence of fetal heart activity in ultra sound sonography
عدم مشاهده ضربان قلب جنين در سونوگرافي
empty
عدم مشاهده ضربان قلب جنين در سونوگرافي
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abbas aflatoonian
Full name of responsible person - Persian: عباس افلاطونیان
Street address - English: Bouali
Street address - Persian: بوعلی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Fax:
Email: abbas/aflatoonian@ssu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Masoud Mirzaei
Full name of responsible person - Persian: مسعود میرزایی
Street address - English: Shahid Sadoughi
Street address - Persian: شهید صدوقی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916978477
Phone: +98 35 3724 0171
Fax:
Email: masoud_mirzaei@hotmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Abbas aflatoonianMasoud Mirzaei Full name of responsible person - Persian: عباس افلاطونیانمسعود میرزایی Street address - English: BoualiShahid Sadoughi Street address - Persian: بوعلیشهید صدوقی City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 89168773918916978477 Phone: +98 35 3824 70853724 0171 Fax: Email: abbas/aflatoonianmasoud_mirzaei@ssu.ac.irhotmail.com Web page address:
Trial results
No
Yes
1
empty
2021-03-07, 1399/12/17
2021-03-07 18:34:41
empty
2020-04-30, 1399/02/11
2020-04-30 00:00:00
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Abstract
Background
Aromatase inhibitors prevent the aromatization of androgens into estrogens, which reduces the negative feedback of estrogen on the hypothalamic-pituitary axis. It is clear that increasing the secretion of follicle-stimulating hormones results in an increased follicular growth.
Objective
This study aimed to evaluate the effect of adding letrozole to gonadotropin on in vitro fertilization outcomes in normal responders.
Materials and Methods
In this randomized clinical trial, 100 normal responder women candidate for controlled ovarian stimulation were randomly enrolled in two groups (n = 50/each). In the case group letrozole was added to gonadotropin in the antagonist protocol. The control group received the conventional antagonist protocol. The main outcome was clinical and chemical pregnancy; and the second outcomes were the number of mature oocytes, the fertilization rate, estradiol level, and the total dose of gonadotropins.
Results
Basic clinical and demographic features were comparable between the groups. Estradiol level on the day of human-chorionic-gonadotropin administration and the total gonadotropin consumption were significantly higher in the control group than the case group (p = 0.045). In addition, the number of MII oocytes was higher (but not significantl) in the case group than the control group (p = 0.09). Moreover, the endometrial thickness was significantly lower in the case group. There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups.
Conclusion
Although adding letrozole to gonadotropin in normal responders reduces the total dose of gonadotropin, it does not improve the pregnancy outcomes.
Abstract Background Aromatase inhibitors prevent the aromatization of androgens into estrogens, which reduces the negative feedback of estrogen on the hypothalamic-pituitary axis. It is clear that increasing the secretion of follicle-stimulating hormones results in an increased follicular growth. Objective This study aimed to evaluate the effect of adding letrozole to gonadotropin on in vitro fertilization outcomes in normal responders. Materials and Methods In this randomized clinical trial, 100 normal responder women candidate for controlled ovarian stimulation were randomly enrolled in two groups (n = 50/each). In the case group letrozole was added to gonadotropin in the antagonist protocol. The control group received the conventional antagonist protocol. The main outcome was clinical and chemical pregnancy; and the second outcomes were the number of mature oocytes, the fertilization rate, estradiol level, and the total dose of gonadotropins. Results Basic clinical and demographic features were comparable between the groups. Estradiol level on the day of human-chorionic-gonadotropin administration and the total gonadotropin consumption were significantly higher in the control group than the case group (p = 0.045). In addition, the number of MII oocytes was higher (but not significantl) in the case group than the control group (p = 0.09). Moreover, the endometrial thickness was significantly lower in the case group. There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups. Conclusion Although adding letrozole to gonadotropin in normal responders reduces the total dose of gonadotropin, it does not improve the pregnancy outcomes.
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خلاصه
زمینه
مهار کننده های آروماتاز از تبدیل آندروژن به استروژن جلوگیری می کنند ، که باعث کاهش بازخورد منفی استروژن در محور هیپوتالاموس-هیپوفیز می شود. واضح است که افزایش ترشح هورمون های محرک فولیکول منجر به افزایش رشد فولیکولی می شود.
هدف
این مطالعه با هدف بررسی تأثیر افزودن لتروزول به گنادوتروپین بر نتایج لقاح آزمایشگاهی در پاسخ دهندگان طبیعی انجام شد.
مواد و روش ها
در این کارآزمایی بالینی تصادفی ، 100 زن پاسخ دهنده طبیعی که داوطلب تحریک کنترل تخمدان بودند به طور تصادفی در دو گروه (50 نفر = هر نفر) ثبت نام شدند. در گروه مورد ، لتروزول به پروتئین آنتاگونیست به گنادوتروپین اضافه شد. گروه کنترل پروتکل آنتاگونیست متعارف را دریافت کرد. نتیجه اصلی حاملگی بالینی و شیمیایی بود. و نتایج دوم تعداد تخمک های بالغ ، میزان لقاح ، سطح استرادیول و دوز کل گنادوتروپین ها بود.
نتایج
ویژگی های اساسی بالینی و دموگرافیک بین دو گروه قابل مقایسه بود. سطح استراديول در روز تجويز گنادوتروپين كوريوني انسان و مصرف كل گنادوتروپين در گروه كنترل به طور معني داري بيشتر از گروه مورد بود (045/0 = p). علاوه بر این ، تعداد تخمک های MII در گروه مورد بیشتر از گروه شاهد بود (اما معنی دار نبود) (09/0 = p). علاوه بر این ، ضخامت آندومتر در گروه مورد به طور قابل توجهی کمتر بود. تفاوت معنی داری در میزان لقاح و میزان بارداری شیمیایی و بالینی بین دو گروه وجود نداشت.
نتیجه
اگرچه افزودن لتروزول به گنادوتروپین در پاسخ دهندگان طبیعی ، دوز کل گنادوتروپین را کاهش می دهد ، اما نتایج بارداری را بهبود نمی بخشد.
خلاصه زمینه مهار کننده های آروماتاز از تبدیل آندروژن به استروژن جلوگیری می کنند ، که باعث کاهش بازخورد منفی استروژن در محور هیپوتالاموس-هیپوفیز می شود. واضح است که افزایش ترشح هورمون های محرک فولیکول منجر به افزایش رشد فولیکولی می شود. هدف این مطالعه با هدف بررسی تأثیر افزودن لتروزول به گنادوتروپین بر نتایج لقاح آزمایشگاهی در پاسخ دهندگان طبیعی انجام شد. مواد و روش ها در این کارآزمایی بالینی تصادفی ، 100 زن پاسخ دهنده طبیعی که داوطلب تحریک کنترل تخمدان بودند به طور تصادفی در دو گروه (50 نفر = هر نفر) ثبت نام شدند. در گروه مورد ، لتروزول به پروتئین آنتاگونیست به گنادوتروپین اضافه شد. گروه کنترل پروتکل آنتاگونیست متعارف را دریافت کرد. نتیجه اصلی حاملگی بالینی و شیمیایی بود. و نتایج دوم تعداد تخمک های بالغ ، میزان لقاح ، سطح استرادیول و دوز کل گنادوتروپین ها بود. نتایج ویژگی های اساسی بالینی و دموگرافیک بین دو گروه قابل مقایسه بود. سطح استراديول در روز تجويز گنادوتروپين كوريوني انسان و مصرف كل گنادوتروپين در گروه كنترل به طور معني داري بيشتر از گروه مورد بود (045/0 = p). علاوه بر این ، تعداد تخمک های MII در گروه مورد بیشتر از گروه شاهد بود (اما معنی دار نبود) (09/0 = p). علاوه بر این ، ضخامت آندومتر در گروه مورد به طور قابل توجهی کمتر بود. تفاوت معنی داری در میزان لقاح و میزان بارداری شیمیایی و بالینی بین دو گروه وجود نداشت. نتیجه اگرچه افزودن لتروزول به گنادوتروپین در پاسخ دهندگان طبیعی ، دوز کل گنادوتروپین را کاهش می دهد ، اما نتایج بارداری را بهبود نمی بخشد.
Protocol summary
Study aim
Effect of adding letrozole to gonadotropin on pregnancy outcomes
Design
Clinical trials, sample size 100 patients, phase 3 of the clinical trial, with the control group, with parallel groups, without blindness, randomized with an enveloped packet.
Settings and conduct
This Randomized clinical trial without blindness is conducted for evaluating the effect of intrauterine injection of PRP in Asherman patients referred to Shahid Sadoughi Hospital or Research and Clinical Center for Infertility, Yazd, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile patients which are the candidate for ART.
Exclusion criteria: History of endocrine disorders, Intrauterine abnormality (uterine polyp & submucosal fibroma & intrauterine adhesions), Azoospermia of partner Severe endometriosis
Intervention groups
Intervention group: since the second day of the cycle all patients Will receive 150 unit gonadotropin, all patients in this group will receive 5 mg letrozole orally science the second day of the cycle When dominant follicle reached to 12-13 mm, antagonist.25 mg will be injected daily subcutaneously. when dominant follicle reaches 17 mm, final triggering will be done.
Control group: since the second day of the cycle all patients Will receive 150 unit gonadotropin, When the dominant follicle reached 12-13 mm, antagonist.25 mg will be injected daily subcutaneously. when dominant follicle reaches 17 mm, final triggering will be done.
Main outcome variables
Chemical pregnancy rate, clinical pregnancy rate
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:IRCT20110509006420N19
Registration date:2018-09-18, 1397/06/27
Registration timing:registered_while_recruiting
Last update:2021-03-07, 1399/12/17
Update count:2
Registration date
2018-09-18, 1397/06/27
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
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding letrozole to gonadotropin on pregnancy outcomes in patients who are the candidate for assisted reproductive techniques
Public title
Letrozole in assisted reproductive techniques protocol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to the Infertility Center, which is undergoing ovulation induction for assisted reproductive techniques.
Exclusion criteria:
History of endocrine disorders
Intrauterine abnormality (uterine polyp & sub mucosal fibroma & intrauterine adhesions)
Azoospermia of partner
Severe endometriosis
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Using computer-generated random numbers in wrapped,
unlabeled envelope each holding a unique number.
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
Ethic commitee of Yazd research center for infertility-Shahid Sadoughi University of Medical Scienc
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
Ir.SSU.RSI.REC.1397.009
Health conditions studied
1
Description of health condition studied
female Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
15 days after embryo transfer
Method of measurement
Blood laboratory kit
2
Description
Clinical pregnancy
Timepoint
3 weeks after positive beta-h Cg
Method of measurement
Observation of fetal heart activity by transvaginal ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.
Category
Treatment - Drugs
2
Description
Intervention group: antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously, all patients in this group will receive 5 mg letrozole (Iran hormone-Iran)) orally science send day of cycle, When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reaserch and clinical for infertility
Full name of responsible person
Abbas aflatoonian
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas/aflatoonian@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Sadoughi
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
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
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the privacy of patients
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
The study protocol, the statistical analysis map, the clinical study report will be available after the publishing of the article.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
use in the retrospective study
From where data/document is obtainable
use in the retrospective study
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
Participant flow diagram
Table of variable outcomes' results
Table of adverse events
First publication date
2020-04-30, 1399/02/11
Abstract of published paper
Abstract
Background
Aromatase inhibitors prevent the aromatization of androgens into estrogens, which reduces the negative feedback of estrogen on the hypothalamic-pituitary axis. It is clear that increasing the secretion of follicle-stimulating hormones results in an increased follicular growth.
Objective
This study aimed to evaluate the effect of adding letrozole to gonadotropin on in vitro fertilization outcomes in normal responders.
Materials and Methods
In this randomized clinical trial, 100 normal responder women candidate for controlled ovarian stimulation were randomly enrolled in two groups (n = 50/each). In the case group letrozole was added to gonadotropin in the antagonist protocol. The control group received the conventional antagonist protocol. The main outcome was clinical and chemical pregnancy; and the second outcomes were the number of mature oocytes, the fertilization rate, estradiol level, and the total dose of gonadotropins.
Results
Basic clinical and demographic features were comparable between the groups. Estradiol level on the day of human-chorionic-gonadotropin administration and the total gonadotropin consumption were significantly higher in the control group than the case group (p = 0.045). In addition, the number of MII oocytes was higher (but not significantl) in the case group than the control group (p = 0.09). Moreover, the endometrial thickness was significantly lower in the case group. There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups.
Conclusion
Although adding letrozole to gonadotropin in normal responders reduces the total dose of gonadotropin, it does not improve the pregnancy outcomes.