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Protocol summary
In this randomized clinical trial with parallel group design, 80 infertile women with poor ovarian response were divided into two intervention 1 and 2 groups. Participates don't aware of the study grouping. The data analyzer is also unaware of the grouping and type of treatment.
In this randomized clinical trial with parallel group design, 90 infertile women with poor ovarian response were divided into two intervention 1 and 2 groups. Participates don't aware of the study grouping.
In this randomized clinical trial with parallel group design, 8090 infertile women with poor ovarian response were divided into two intervention 1 and 2 groups. Participates don't aware of the study grouping. The data analyzer is also unaware of the grouping and type of treatment.
در اين كارازمايي باليني تصادفي شده 80 بيمار نابارور كه داراي پاسخ ضعيف تخداني هستند به دو گروه مداخله 1 و 2 با گروه هاي درماني موازي تقسيم مي شوند و هيچكدام از گروه بندي مطالعه آگاهي ندارند. اناليز كننده داده ها نيز از گروهبندي و نوع درمان اطلاعي ندارد.
در اين كارازمايي باليني تصادفي شده 90 بيمار نابارور كه داراي پاسخ ضعيف تخمداني هستند به دو گروه مداخله 1 و 2 با گروه هاي درماني موازي تقسيم مي شوند و هيچكدام از گروه بندي مطالعه آگاهي ندارند.
در اين كارازمايي باليني تصادفي شده 8090 بيمار نابارور كه داراي پاسخ ضعيف تخدانيتخمداني هستند به دو گروه مداخله 1 و 2 با گروه هاي درماني موازي تقسيم مي شوند و هيچكدام از گروه بندي مطالعه آگاهي ندارند. اناليز كننده داده ها نيز از گروهبندي و نوع درمان اطلاعي ندارد.
This study is done at Yazd infertility clinic. The participants and data analyzer don't aware about grouping.
This study is done at Yazd infertility clinic. The participants don't aware about grouping.
This study is done at Yazd infertility clinic. The participants and data analyzer don't aware about grouping.
اين مطالعه در كلينيك درمانی ناباروری یزد انجام می شود. شركت كنندگان و اناليزور داده ها از گروهبندي اطلاعي ندارند.
اين مطالعه در كلينيك درمانی ناباروری یزد انجام می شود. شركت كنندگان از گروهبندي اطلاعي ندارند.
اين مطالعه در كلينيك درمانی ناباروری یزد انجام می شود. شركت كنندگان و اناليزور داده ها از گروهبندي اطلاعي ندارند.
Inclusion criteria:
Based on the Bologna criteria, poor responder women are included in the study who have two of the following three criteria:
Age more than 40 years or other risk factors for poor ovarian response; Less than three oocytes in the previous IVF cycle; Abnormal ovarian reserve test;
Two episodes of poor ovarian response with maximal stimulation in previous cycles without other criteria.
Exclusion criteria:
Severe male factor; Untreated thyroid disorders; Severe uterine anomaly; BMI less than 18 and more than 35; Hyperprolactinemia; Congenital adrenal hyperplasia
Inclusion criteria:
Based on the Bologna criteria, poor responder women are included in the study who have two of the following three criteria:
Age more than 40 years or other risk factors for poor ovarian response; Less than three oocytes in the previous IVF cycle; Abnormal ovarian reserve test;
Two episodes of poor ovarian response with maximal stimulation in previous cycles without other criteria.
Exclusion criteria:
Severe male factor; Untreated endocrine disorders; Severe uterine anomaly;
Inclusion criteria: Based on the Bologna criteria, poor responder women are included in the study who have two of the following three criteria: Age more than 40 years or other risk factors for poor ovarian response; Less than three oocytes in the previous IVF cycle; Abnormal ovarian reserve test; Two episodes of poor ovarian response with maximal stimulation in previous cycles without other criteria. Exclusion criteria: Severe male factor; Untreated thyroidendocrine disorders; Severe uterine anomaly; BMI less than 18 and more than 35; Hyperprolactinemia; Congenital adrenal hyperplasia
معيارهاي ورود:
بر اساس معیارهای Bologna خانمهای poor responder به مطالعه وارد میشوند که واجد 2 مورد از سه معیار زیر باشند:
سن بیشتر مساوی 40 سال و یا سایر ریسک فاکتورهای پاسخ ضعیف تخمدان؛ تعداد کمتر مساوی سه اووسیت در سیکل قبلی IVF؛ تست غیر طبیعی ذخیره تخمدان؛ دو اپیزود پاسخ ضعیف تخمدان با حداکثر تحریک در سیکلهای قبلی بدون وجود سایر معیارها
معيارهاي خروج:
فاکتور مردانه شدید؛ اختلالات تیروئید درمان نشده؛ آنومالی رحمی شدید؛ BMI كمتر از 18 و بيشتر از 35؛ هايپرپرولاكتينمي؛ هايپرپلازي مادرادي ادرنال
معيارهاي ورود:
بر اساس معیارهای Bologna خانمهای poor responder به مطالعه وارد میشوند که واجد 2 مورد از سه معیار زیر باشند:
سن بیشتر مساوی 40 سال و یا سایر ریسک فاکتورهای پاسخ ضعیف تخمدان؛ تعداد کمتر مساوی سه اووسیت در سیکل قبلی IVF؛ تست غیر طبیعی ذخیره تخمدان؛ دو اپیزود پاسخ ضعیف تخمدان با حداکثر تحریک در سیکلهای قبلی بدون وجود سایر معیارها
معيارهاي خروج:
فاکتور مردانه شدید؛ اختلالات اندوکرین درمان نشده؛ آنومالی رحمی شدید؛
معيارهاي ورود: بر اساس معیارهای Bologna خانمهای poor responder به مطالعه وارد میشوند که واجد 2 مورد از سه معیار زیر باشند: سن بیشتر مساوی 40 سال و یا سایر ریسک فاکتورهای پاسخ ضعیف تخمدان؛ تعداد کمتر مساوی سه اووسیت در سیکل قبلی IVF؛ تست غیر طبیعی ذخیره تخمدان؛ دو اپیزود پاسخ ضعیف تخمدان با حداکثر تحریک در سیکلهای قبلی بدون وجود سایر معیارها معيارهاي خروج: فاکتور مردانه شدید؛ اختلالات تیروئیداندوکرین درمان نشده؛ آنومالی رحمی شدید؛ BMI كمتر از 18 و بيشتر از 35؛ هايپرپرولاكتينمي؛ هايپرپلازي مادرادي ادرنال
General information
30
18
3018
Double blinded
Single blinded
doublsingl
1
1
80
90
8090
empty
84
84
empty
2019-09-06, 1398/06/15
2019-09-06 00:00:00
empty
2020-02-09, 1398/11/20
2020-02-09 00:00:00
empty
2020-08-22, 1399/06/01
2020-08-22 00:00:00
empty
a mistake in recording sample size and type of study
a mistake in recording sample size and type of study
empty
اشتباه در ثبت حجم نمونه و نوع مطالعه
اشتباه در ثبت حجم نمونه و نوع مطالعه
Age more than 40 years or other risk factors for poor ovarian response.
Less than three oocytes in the previous IVF cycle
Abnormal ovarian reserve test
Age more than 40 years or other risk factors for poor ovarian response.
Less than three oocytes in the previous IVF cycle
Abnormal ovarian reserve test
Two histories of poor ovarian response following receiving maximal stimulation
Age more than 40 years or other risk factors for poor ovarian response. Less than three oocytes in the previous IVF cycle Abnormal ovarian reserve test Two histories of poor ovarian response following receiving maximal stimulation
سن بیشتر مساوی 40 سال و یا سایر ریسک فاکتورهای پاسخ ضعیف تخمدان
تعداد کمتر مساوی سه اووسیت در سیکل قبلی IVF
تست غیر طبیعی ذخیره تخمدان
سن بیشتر مساوی 40 سال و یا سایر ریسک فاکتورهای پاسخ ضعیف تخمدان
تعداد کمتر مساوی سه اووسیت در سیکل قبلی IVF
تست غیر طبیعی ذخیره تخمدان
سابقه 2 بار پاسخ ضعیف تخمدان در سیکل درمانی با حداکثر دوز
سن بیشتر مساوی 40 سال و یا سایر ریسک فاکتورهای پاسخ ضعیف تخمدان تعداد کمتر مساوی سه اووسیت در سیکل قبلی IVF تست غیر طبیعی ذخیره تخمدان سابقه 2 بار پاسخ ضعیف تخمدان در سیکل درمانی با حداکثر دوز
Severe male factor
Untreated thyroid disorders
Severe uterine anomaly
BMI less than 18 and more than 35
Hyperprolactinemia
Congenital adrenal hyperplasia
Severe male factor
Untreated endocrine disorders
Severe uterine anomaly
Severe male factor Untreated thyroidendocrine disorders Severe uterine anomaly BMI less than 18 and more than 35 Hyperprolactinemia Congenital adrenal hyperplasia
فاکتور مردانه شدید
اختلالات تیروئید درمان نشده
آنومالی رحمی شدید
BMI كمتر از 18 و بيشتر از 35
هايپرپرولاكتينمي
هايپرپلازي مادرادي ادرنال
فاکتور مردانه شدید اختلالات تیروئیداندوکرین درمان نشده آنومالی رحمی شدید BMI كمتر از 18 و بيشتر از 35 هايپرپرولاكتينمي هايپرپلازي مادرادي ادرنال
This is a double-blind study. The participants and data analyzer don't aware about grouping name and type of treatment in each group.
This is a double-blind study. The participants don't aware about grouping name and type of treatment in each group.
This is a double-blind study. The participants and data analyzer don't aware about grouping name and type of treatment in each group.
این مطالعه از نوع دوسویه کور است. افراد شرکت کننده و همچنین اناليز كننده داده ها در مورد گروه بندي و نوع درمان اطلاعي ندارد.
این مطالعه از نوع یک سویه کور است. افراد شرکت کننده در مورد گروه بندي و نوع درمان اطلاعي ندارد.
این مطالعه از نوع دوسویهیک سویه کور است. افراد شرکت کننده و همچنین اناليز كننده داده ها در مورد گروه بندي و نوع درمان اطلاعي ندارد.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Prof Abbas Aflatoonian
Full name of responsible person - Persian: پروفسور عباس افلاطونيان
Street address - English: Bu ali Ave- Safaeieh
Street address - Persian: صفائيه خيابان بوعلي
City - English: Yazd
City - Persian: يزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 8119
Fax:
Email: M_mortazavi58@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Masoud Mirzaee
Full name of responsible person - Persian: دكتر مسعود ميرزايي
Street address - English: Bu Ali Ave- Safaeieh
Street address - Persian: صفائيه خيابان بوعلي
City - English: Yazd
City - Persian: يزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 8119
Fax:
Email: M_mortazavi58@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Prof Abbas AflatoonianDr Masoud Mirzaee Full name of responsible person - Persian: پروفسور عباس افلاطونياندكتر مسعود ميرزايي Street address - English: Bu aliAli Ave- Safaeieh Street address - Persian: صفائيه خيابان بوعلي City - English: Yazd City - Persian: يزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 8119 Fax: Email: M_mortazavi58@yahoo.com Web page address:
Protocol summary
Study aim
Evaluation and comparison of two Trigger methods, dubble trigger (HCG + GNRH agonist) and Trigger with HCG on oocyte maturation in patients with poor ovarian response.
Design
In this randomized clinical trial with parallel group design, 90 infertile women with poor ovarian response were divided into two intervention 1 and 2 groups. Participates don't aware of the study grouping.
Settings and conduct
This study is done at Yazd infertility clinic. The participants don't aware about grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Based on the Bologna criteria, poor responder women are included in the study who have two of the following three criteria:
Age more than 40 years or other risk factors for poor ovarian response; Less than three oocytes in the previous IVF cycle; Abnormal ovarian reserve test;
Two episodes of poor ovarian response with maximal stimulation in previous cycles without other criteria.
Exclusion criteria:
Severe male factor; Untreated endocrine disorders; Severe uterine anomaly;
Intervention groups
All patients under antagonist protocol receive 250-300 unit recombinant FSH from the second day of menstrual cycle and when dominant follicle size be13-14 mm , the antagonist (cetrotide or olegalotran ampoule) is started at a dose of 250 μg daily and continues until trigger day.
Intervention group 1: In this group Trigger done with 0.2 mg Deca peptil ampoule and 1000unit HCG ampoule 34-40 hours before oocyte retriveal.
Intervention group 2: In this group triggers were performed by standard trigger method with 1000 HCG units approximately 36 hours before oocyte retriveal.
Main outcome variables
Follicles number; Number of recovered oocytes; Number of embryos; Pregnancy rate.
General information
Reason for update
a mistake in recording sample size and type of study
Acronym
IRCT registration information
IRCT registration number:IRCT20190409043207N2
Registration date:2019-10-22, 1398/07/30
Registration timing:registered_while_recruiting
Last update:2021-03-02, 1399/12/12
Update count:3
Registration date
2019-10-22, 1398/07/30
Registrant information
Name
Soheila Pourmasumi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0086
Email address
pourmasumis871@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
2019-09-06, 1398/06/15
Actual recruitment end date
2020-02-09, 1398/11/20
Trial completion date
2020-08-22, 1399/06/01
Scientific title
Comparison of two methods of double- trigger (GNRHa+HCG) and HCG-trigger on final oocyte maturation in poor responder patients.
Public title
Comparison of oocyte quality in patients with poor ovarian response undergone two triggering methods.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 40 years or other risk factors for poor ovarian response.
Less than three oocytes in the previous IVF cycle
Abnormal ovarian reserve test
Two histories of poor ovarian response following receiving maximal stimulation
Exclusion criteria:
Severe male factor
Untreated endocrine disorders
Severe uterine anomaly
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
90
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
By random number table couples that participated in the study divided into experiments 1 and 2 groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a double-blind study. The participants don't aware about grouping name and type of treatment in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Bouali Ave, Safayeh.
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.SSU.RSI.REC.1398.011
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Number of follicles
Timepoint
From the tenth day of the cycle
Method of measurement
sonography
2
Description
Number of recovered oocytes
Timepoint
Oocyte recovery day
Method of measurement
observation
3
Description
Number of canceled cycles
Timepoint
Oocyte recovery day
Method of measurement
observation
4
Description
Number of embryo
Timepoint
2 days after Oocyte recovery
Method of measurement
observation
5
Description
embryo grading
Timepoint
3 days after Oocyte recovery
Method of measurement
observation
6
Description
Number of transferred embryo
Timepoint
embryo transferee day
Method of measurement
observation
Secondary outcomes
1
Description
Chemical pregnancy rate
Timepoint
14 days after embryo transfer
Method of measurement
positive B-HCG
2
Description
clinical pregnancy rate
Timepoint
4 weeks after embryo transfer
Method of measurement
fetal heart rate in sonography
Intervention groups
1
Description
Intervention group: Intervention group: Trigger with 0.2 mg deca peptil ampoule and 10000 HCG ampoule 40 and 34 hours before oocyte retrieval.
Category
Treatment - Drugs
2
Description
Intervention group: Trigger by standard method with 10000units HCG 36 hours before oocyte retrieval.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical center for infertility
Full name of responsible person
Prof Abbas Aflatoonian
Street address
Bu ali Ave, Safaeieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8119
Email
M_mortazavi58@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masoud Mirzaee
Street address
Bu Ali Ave- Safaeieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8119
Email
M_mortazavi58@yahoo.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
Dr maryam Mortazavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bu Ali Ave, Safaeieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8119
Email
m_mortazavi58@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Maryam Mortazavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bu Ali Ave- Safaeieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8119
Email
m_mortazavi58@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Maryam Mortazavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bu Ali Ave- Safaeieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8119
Email
m_mortazavi58@yahoo.com
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 data obtained from this study will be released after being unidentified studies participants
When the data will become available and for how long
Get started 6 months after publishing study results
To whom data/document is available
The findings of this study will be accessible to all individuals
Under which criteria data/document could be used
To improve pregnancy outcomes in infertility clinics
From where data/document is obtainable
Yazd Research and Clinical Center for Infertility
What processes are involved for a request to access data/document
Receiving the author's confirmation and obtaining approval from the director of the Yazd Infertility Clinic