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Protocol summary
This study is done at Yazd infertility clinic. The participants don't aware about grouping.
This study is done at Yazd infertility clinic.
This study is done at Yazd infertility clinic. The participants don't aware about grouping.
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.
اين مطالعه در كلينيك درمانی ناباروری یزد انجام می شود. شركت كنندگان از گروهبندي اطلاعي ندارند.
General information
Single blinded
Not blinded
singlnotbl
1
1
2
3
23
Modification in Exclusion criteria, and recording the priority and latency of the most important results
type of blinding correction
Modification in Exclusion criteria, and recording the priority and latencytype of the most important resultsblinding correction
تصحیح معیار خروج، و ثبت تقدم و تاخر مهمترین نتایج
تصحیح نوع کورسازی
تصحیح معیار خروج، و ثبت تقدم و تاخر مهمترین نتایجنوع کورسازی
Comparison of oocyte quality in patients with poor ovarian response undergone two triggering methods.
Comparison of the oocyte quality in patients with poor ovarian response undergone two triggering methods.
Comparison of the oocyte quality in patients with poor ovarian response undergone two triggering methods.
Comparison of two methods of double- trigger (GNRHa+HCG) and HCG-trigger on final oocyte maturation in poor responder patients.
Comparison of two methods of double- trigger (GNRHa+HCG) and HCG-trigger on the final oocyte maturation in poor responder patients.
Comparison of two methods of double- trigger (GNRHa+HCG) and HCG-trigger on the final oocyte maturation in poor responder patients.
By random number table couples that participated in the study divided into experiments 1 and 2 groups.
For randomization selection of the patients, through the site www. randomization.ir, we create a list of random numbers for assigning patients to treatment groups (A&B). Then, the number of each patient, which is according to the entrance number to the clinic, is written on the envelope, and the type of treatment that was randomly selected through the mentioned site is put in the envelope. Also, thick envelopes are used in the aim to not be identifiable, the type of treatment for each patient, in the envelope, by the people who make the random assignment of the patient. In this way, each patient, who refer for giving treatment, comes with an envelope containing the type of assigned treatment.
ByFor randomization selection of the patients, through the site www. randomization.ir, we create a list of random numbers for assigning patients to treatment groups (A&B). Then, the number table couplesof each patient, which is according to the entrance number to the clinic, is written on the envelope, and the type of treatment that participatedwas randomly selected through the mentioned site is put in the study divided into experiments 1 and 2 groupsenvelope. Also, thick envelopes are used in the aim to not be identifiable, the type of treatment for each patient, in the envelope, by the people who make the random assignment of the patient. In this way, each patient, who refer for giving treatment, comes with an envelope containing the type of assigned treatment.
از طریق جدول اعداد تصادفي زوج های شرکت کننده در مطالعه به گروه های مداخله 1و2 تقسیم مي شوند.
برای انتخاب تصادفی افراد، از طریق سایت www.randomization.ir یک لیست از اعداد تصادفی برای تخصیص بیماران به گروههای درمانی (A&B) ایجاد میکنیم. سپس شماره بیماران که به ترتیب اخذ نوبت در کلینیک می باشد، روی پاکت نوشته شده و نوع درمان را که از طریق سایت مذکور به صورت تصادفی انتخاب شده را داخل پاکت می گذاریم. در صمن از پاکت های ضخیم استفاه می شود تا نوع درمان داخل پاکت برای هر بیمار، توسط افرادیکه تخصیص تصادفی بیمار را بانجام می دهد قابل شناسایی نباشد. با این شیوه هر بیماری که برای درمان مراجعه می کند، یک پاکت حاوی نوع درمان اختصاص داده شده را به همراه دارد.
برای انتخاب تصادفی افراد، از طریق جدولسایت www.randomization.ir یک لیست از اعداد تصادفي زوجتصادفی برای تخصیص بیماران به گروههای درمانی (A&B) ایجاد میکنیم. سپس شماره بیماران که به ترتیب اخذ نوبت در کلینیک می باشد، روی پاکت نوشته شده و نوع درمان را که از طریق سایت مذکور به صورت تصادفی انتخاب شده را داخل پاکت می گذاریم. در صمن از پاکت های شرکت کننده در مطالعهضخیم استفاه می شود تا نوع درمان داخل پاکت برای هر بیمار، توسط افرادیکه تخصیص تصادفی بیمار را بانجام می دهد قابل شناسایی نباشد. با این شیوه هر بیماری که برای درمان مراجعه می کند، یک پاکت حاوی نوع درمان اختصاص داده شده را به گروه های مداخله 1و2 تقسیم مي شوندهمراه دارد.
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 don't aware about grouping name and type of treatment in each group.
این مطالعه از نوع یک سویه کور است. افراد شرکت کننده 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.
Primary outcomes
#1
clinical pregnancy rate
Clinical pregnancy rate
clinicalClinical pregnancy rate
4 weeks after positive beta hCG
Four weeks after positive beta hCG
4Four weeks after positive beta hCG
fetal heart activity by trans-vaginal ultrasonography
Fetal heart activity by trans-vaginal ultrasonography
fetalFetal heart activity by trans-vaginal ultrasonography
Secondary outcomes
#1
positive B-HCG
Positive B-HCG
positivePositive B-HCG
#2
implantation rate
Implantation rate
implantationImplantation rate
is defined as the numbers of gestational sacs that detected throughout sonography per number of embryos transferred (100 embryo)
It is defined as the numbers of gestational sacs that detected throughout sonography per number of embryos transferred (100 embryo)
It is defined as the numbers of gestational sacs that detected throughout sonography per number of embryos transferred (100 embryo)
تعداد ساک مشاهده شده در سونوگرافی به ازاء جنین انتقال یافته (100 جنین)
بوسیله تعداد ساک مشاهده شده در سونوگرافی به ازاء جنین انتقال یافته (100 جنین) مشخص می شود.
بوسیله تعداد ساک مشاهده شده در سونوگرافی به ازاء جنین انتقال یافته (100 جنین) مشخص می شود.
#3
abortion rate
Abortion rate
abortionAbortion rate
before 20th weeks of gestation.
Before 20th weeks of gestation.
beforeBefore 20th weeks of gestation.
observation and counting
Observation and counting
observationObservation and counting
#4
the day of oocyte puncture
The day of oocyte puncture
theThe day of oocyte puncture
counting
Counting
countingCounting
#5
the day of puncture
The day of puncture
theThe day of puncture
counting
Counting
countingCounting
#6
counting
Counting
countingCounting
#7
estradiol level
Estradiol level
estradiolEstradiol level
#8
embryo grading
Embryo grading
embryoEmbryo grading
observation and grading according to the embryo references
Observation and grading according to the embryo references
observationObservation and grading according to the embryo references
Sharing plan
Get started 6 months after publishing study results
Get started 6 months after publishing the study results
Get started 6 months after publishing the study results
The findings of this study will be accessible to all individuals
The findings of this study will be accessible for all individuals
The findings of this study will be accessible tofor all individuals
To improve pregnancy outcomes in infertility clinics
To improve pregnancy outcomes of the infertility centers
To improve pregnancy outcomes inof the infertility clinicscenters
به منظور ارتقای نتایج بارداری در کلینیک های ناباروری
به منظور ارتقای نتایج بارداری در مراکز ناباروری
به منظور ارتقای نتایج بارداری در کلینیک هایمراکز ناباروری
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.
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
type of blinding correction
Acronym
IRCT registration information
IRCT registration number:IRCT20190409043207N2
Registration date:2019-10-22, 1398/07/30
Registration timing:registered_while_recruiting
Last update:2021-08-11, 1400/05/20
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 the final oocyte maturation in poor responder patients.
Public title
Comparison of the 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
3
Groups that have been masked
No information
Sample size
Target sample size:
122
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization selection of the patients, through the site www. randomization.ir, we create a list of random numbers for assigning patients to treatment groups (A&B). Then, the number of each patient, which is according to the entrance number to the clinic, is written on the envelope, and the type of treatment that was randomly selected through the mentioned site is put in the envelope. Also, thick envelopes are used in the aim to not be identifiable, the type of treatment for each patient, in the envelope, by the people who make the random assignment of the patient. In this way, each patient, who refer for giving treatment, comes with an envelope containing the type of assigned treatment.
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 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
Clinical pregnancy rate
Timepoint
Four weeks after positive beta hCG
Method of measurement
Fetal heart activity by trans-vaginal ultrasonography
Secondary outcomes
1
Description
Biochemical pregnancy rate
Timepoint
14 days after embryo transfer
Method of measurement
Positive B-HCG
2
Description
Implantation rate
Timepoint
4 weeks after embryo transfer
Method of measurement
It is defined as the numbers of gestational sacs that detected throughout sonography per number of embryos transferred (100 embryo)
3
Description
Abortion rate
Timepoint
Before 20th weeks of gestation.
Method of measurement
Observation and counting
4
Description
COC counting
Timepoint
The day of oocyte puncture
Method of measurement
Counting
5
Description
MII oocyte number
Timepoint
The day of puncture
Method of measurement
Counting
6
Description
2PN number
Timepoint
1 day after fertilization
Method of measurement
Counting
7
Description
Estradiol level
Timepoint
In the day of hCG injection
Method of measurement
Biochemical measurements in the blood
8
Description
Embryo grading
Timepoint
3 days after puncture
Method of measurement
Observation and grading according to the embryo references
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 the study results
To whom data/document is available
The findings of this study will be accessible for all individuals
Under which criteria data/document could be used
To improve pregnancy outcomes of the infertility centers
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