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Comparison of two methods of double- trigger (GNRHa+HCG) and HCG-trigger on final oocyte maturation in poor responder patients.

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History
# Registration date Revision Id
4 2021-04-12, 1400/01/23 193593
3 2021-04-07, 1400/01/18 177916
2 2021-03-02, 1399/12/12 173456
1 2019-10-22, 1398/07/30 108623
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  • General information

    90
    122
    84
    90
    a mistake in recording sample size and type of study
    Modification in Exclusion criteria, and recording the priority and latency of the most important results
    اشتباه در ثبت حجم نمونه و نوع مطالعه
    تصحیح معیار خروج، و ثبت تقدم و تاخر مهمترین نتایج

  • Primary outcomes

    #1
    Number of follicles
    clinical pregnancy rate
    تعداد تخمک
    میزان حاملگی بالینی
    From the tenth day of the cycle
    4 weeks after positive beta hCG
    از روز دهم چرخه
    4 هفته پس hcg مثبت
    sonography
    fetal heart activity by trans-vaginal ultrasonography
    سونوگرافی
    ضربان قلب در سونوگرافی
    #2
    Number of recovered oocytes
    empty
    تعداد تخمک بازیافتی
    empty
    Oocyte recovery day
    empty
    روز تخمک گیری
    empty
    observation
    empty
    مشاهده
    empty
    #3
    Number of canceled cycles
    empty
    تعداد سیکل هاي لغو شده
    empty
    Oocyte recovery day
    empty
    روز تخمک گیری
    empty
    observation
    empty
    مشاهده
    empty
    #4
    Number of embryo
    empty
    تعداد جنین
    empty
    2 days after Oocyte recovery
    empty
    2 روز بعد تخمک گیری
    empty
    observation
    empty
    مشاهده
    empty
    #5
    embryo grading
    empty
    گریدینگ جنین
    empty
    3 days after Oocyte recovery
    empty
    3 روز بعد تخمک گیری
    empty
    observation
    empty
    مشاهده
    empty
    #6
    Number of transferred embryo
    empty
    جنین هاي ترانسفر شده
    empty
    embryo transferee day
    empty
    روز انتقال جنين
    empty
    observation
    empty
    مشاهده
    empty

  • Secondary outcomes

    #1
    Chemical pregnancy rate
    Biochemical pregnancy rate
    ميزان حاملگي شيميايي
    ميزان حاملگي بیوشيميايي
    #2
    clinical pregnancy rate
    implantation rate
    ميزان حاملگي كلينيكي
    میزان لانه گزینی
    4 هفته بعد از انتقال جنين
    4 هفته پس از انتقال جنین
    fetal heart rate in sonography
    is defined as the numbers of gestational sacs that detected throughout sonography per number of embryos transferred (100 embryo)
    ضربان قلب در سونوگرافي
    تعداد ساک مشاهده شده در سونوگرافی به ازاء جنین انتقال یافته (100 جنین)
    #3
    empty
    abortion rate
    empty
    میزان سقط
    empty
    before 20th weeks of gestation.
    empty
    تا 20 هفته پس از انتقال جنین
    empty
    observation and counting
    empty
    مشاهده و شمارش
    #4
    empty
    COC counting
    empty
    تعداد تخمک همراه با کومولوس
    empty
    the day of oocyte puncture
    empty
    در روز تخمک کشی
    empty
    counting
    empty
    شمارش
    #5
    empty
    MII oocyte number
    empty
    تعداد تخمک بالغ شده
    empty
    the day of puncture
    empty
    روز تخمک کشی
    empty
    counting
    empty
    شمارش
    #6
    empty
    2PN number
    empty
    تعداد تخمک بارور شده
    empty
    1 day after fertilization
    empty
    یک روز پس از لقاح
    empty
    counting
    empty
    شمارش
    #7
    empty
    estradiol level
    empty
    میزان استرادیول
    empty
    In the day of hCG injection
    empty
    روز تزریق hcg
    empty
    Biochemical measurements in the blood
    empty
    اندازه گیری بیوشیمیایی در خون
    #8
    empty
    embryo grading
    empty
    گریدینگ جنین
    empty
    3 days after puncture
    empty
    3روز پس از تخمک کشی
    empty
    observation and grading according to the embryo references
    empty
    مشاهده و نمره دهی بر اساس رفرنس های جنین شناسی

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
Modification in Exclusion criteria, and recording the priority and latency of the most important results
Acronym
IRCT registration information
IRCT registration number: IRCT20190409043207N2
Registration date: 2019-10-22, 1398/07/30
Registration timing: registered_while_recruiting

Last update: 2021-04-09, 1400/01/20
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 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: 122
Actual sample size reached: 90
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
clinical pregnancy rate
Timepoint
4 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
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 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
Comments
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