comparison of ovulation triggering outcome using these two methods: standard dose of human chorionic gonadotropin and human chorionic gonadotropin In combination with gonadotropin releasing hormone in IVF/ICSI cycles
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Protocol summary
This will be a two arm parallel group design of 40 patients candidate of IVF/ICSI , single blind randomised trial, with a computer-generated randomization list with a block size of 4, with 1:1 allocation.
This will be a two arm parallel group design of 100 patients candidate of IVF/ICSI , single blind randomised trial, with a computer-generated randomization list with a block size of 4, with 1:1 allocation.
This will be a two arm parallel group design of 40100 patients candidate of IVF/ICSI , single blind randomised trial, with a computer-generated randomization list with a block size of 4, with 1:1 allocation.
این مطالعه کارآزمایی بالینی با دو بازوی موازی یکسویه کور، تصادفی شده بر روی 40 بیمار کاندید IVF/ICSI انجام خواهد شد که تصادفی سازی آنها با بلوک های 4 تایی و جا گذاری 1به1 انجام خواهد شد.
این مطالعه کارآزمایی بالینی با دو بازوی موازی یکسویه کور، تصادفی شده بر روی 100 بیمار کاندید IVF/ICSI انجام خواهد شد که تصادفی سازی آنها با بلوک های 4 تایی و جا گذاری 1به1 انجام خواهد شد.
این مطالعه کارآزمایی بالینی با دو بازوی موازی یکسویه کور، تصادفی شده بر روی 40100 بیمار کاندید IVF/ICSI انجام خواهد شد که تصادفی سازی آنها با بلوک های 4 تایی و جا گذاری 1به1 انجام خواهد شد.
during ovarian stimulation and ultrasound control when there is at least 5 or more follicles above 17 mm in diameter we administer 0.2 mg decapeptide and 1500 unit HcG for triggering ovulation in the study group or 5000 unit HcG in the control group.
during ovarian stimulation and ultrasound control when there is at least 5 or more follicles above 17 mm in diameter we administer 0.2 mg decapeptide and 2500 unit HcG for triggering ovulation in the study group or 2 ampoules of 5000 unit HcG equivalent to 10,000 units HcG in the control group.
during ovarian stimulation and ultrasound control when there is at least 5 or more follicles above 17 mm in diameter we administer 0.2 mg decapeptide and 15002500 unit HcG for triggering ovulation in the study group or 2 ampoules of 5000 unit HcG equivalent to 10,000 units HcG in the control group.
در طی تحریک تخمدانی وقتی حداقل 5 فولیکول 17 میلیمتری یا بیشتر در بررسی سونوگرافی رویت شود، در گروه مطالعه 0.2 میلیگرم دکاپپتید و 1500 واحد HcG و در گروه کنترول 5000 واحد HcG جهت تحریک تخمک گذاری تجویز خواهد شد.
در طی تحریک تخمدانی وقتی حداقل 5 فولیکول 17 میلیمتری یا بیشتر در بررسی سونوگرافی رویت شود، در گروه مطالعه 0.2 میلیگرم دکاپپتید و 2500 واحد HcG و در گروه کنترول دو آمپول 5000 واحد HcG معادل 10000 واحد جهت تحریک تخمک گذاری تجویز خواهد شد.
در طی تحریک تخمدانی وقتی حداقل 5 فولیکول 17 میلیمتری یا بیشتر در بررسی سونوگرافی رویت شود، در گروه مطالعه 0.2 میلیگرم دکاپپتید و 15002500 واحد HcG و در گروه کنترول دو آمپول 5000 واحد HcG معادل 10000 واحد جهت تحریک تخمک گذاری تجویز خواهد شد.
General information
40
100
40100
empty
increment of the sample size and change in the dose of the drug in the control and intervention group because of the mistake in typing
increment of the sample size and change in the dose of the drug in the control and intervention group because of the mistake in typing
empty
افزایش حجم نمونه و تغییر دوز دارو در گروه مداخله و استاندارد به علت اشتباه تایپی
افزایش حجم نمونه و تغییر دوز دارو در گروه مداخله و استاندارد به علت اشتباه تایپی
Intervention groups
#1
Intervention group: 1500 unit human chorionic gonadotropin In combination with 0.2 miligram gonadotropin releasing hormone
Intervention group: 2500 unit human chorionic gonadotropin In combination with 0.2 miligram gonadotropin releasing hormone
Intervention group: 15002500 unit human chorionic gonadotropin In combination with 0.2 miligram gonadotropin releasing hormone
گروه مداخله: تحریک تخمک گذاری با استفاده از ترکیب 1500 واحد هورمون گنادوتروپین جفتی با 0.2 میلیگرم هورمون آزادکننده گنادوتروپین
گروه مداخله: تحریک تخمک گذاری با استفاده از ترکیب 2500 واحد هورمون گنادوتروپین جفتی با 0.2 میلیگرم هورمون آزادکننده گنادوتروپین
گروه مداخله: تحریک تخمک گذاری با استفاده از ترکیب 15002500 واحد هورمون گنادوتروپین جفتی با 0.2 میلیگرم هورمون آزادکننده گنادوتروپین
#2
Control group: 5000 unit human chorionic gonadotropin for triggering
Control group: 10000 unit human chorionic gonadotropin for triggering
Control group: 500010000 unit human chorionic gonadotropin for triggering
گروه کنترل: تحریک تخمک گذاری با 5000 واحد هورمون گنادوتروپین جفتی
گروه کنترل: تحریک تخمک گذاری با 10000 واحد هورمون گنادوتروپین جفتی
گروه کنترل: تحریک تخمک گذاری با 500010000 واحد هورمون گنادوتروپین جفتی
Recruitment centers
#1
Name of recruitment center - English: بیمارستان الزهرا(س)
Name of recruitment center - Persian: Alzahra Hospita
Full name of responsible person - English: دكتر نازلي نوالي
Full name of responsible person - Persian: Nazli Navali
Street address - English: south Artesh street
Street address - Persian: خیابان ارتش جنوبی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 3554 1221
Fax:
Email: navalin@tbzmed.ac.ir
Web page address: http://alzahrahosp.tbzmed.ac.ir
Name of recruitment center - English: Alzahra Hospital
Name of recruitment center - Persian: (بیمارستان الزهرا(س)
Full name of responsible person - English: Navali Nazli
Full name of responsible person - Persian: دكتر نازلي نوالي
Street address - English: south Artesh street
Street address - Persian: خیابان ارتش جنوبی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 3554 1221
Fax:
Email: navalin@tbzmed.ac.ir
Web page address: http://alzahrahosp.tbzmed.ac.ir
Name of recruitment center - English: بیمارستان الزهرا(س)Alzahra Hospital Name of recruitment center - Persian: Alzahra Hospita(بیمارستان الزهرا(س) Full name of responsible person - English: دكتر نازلي نواليNavali Nazli Full name of responsible person - Persian: Nazli Navaliدكتر نازلي نوالي Street address - English: south Artesh street Street address - Persian: خیابان ارتش جنوبی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5138665793 Phone: +98 41 3554 1221 Fax: Email: navalin@tbzmed.ac.ir Web page address: http://alzahrahosp.tbzmed.ac.ir
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: خانم دکترالهه صاحب اولاد مدارک
Full name of responsible person - Persian: خانم دکترالهه صاحب اولاد مدارک
Street address - English: Artesh street
Street address - Persian: خیابان ارتش جنوبی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 3554 1221
Fax:
Email: navalin@tbzmed.ac.ir
Web page address: http://alzahrahosp.tbzmed.ac.ir
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Elahe Saheb Olad Madarek
Full name of responsible person - Persian: خانم دکترالهه صاحب اولاد مدارک
Street address - English: Artesh street
Street address - Persian: خیابان ارتش جنوبی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 3554 1221
Fax:
Email: navalin@tbzmed.ac.ir
Web page address: http://alzahrahosp.tbzmed.ac.ir
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: خانم دکترالهه صاحب اولاد مدارکDr. Elahe Saheb Olad Madarek Full name of responsible person - Persian: خانم دکترالهه صاحب اولاد مدارک Street address - English: Artesh street Street address - Persian: خیابان ارتش جنوبی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5138665793 Phone: +98 41 3554 1221 Fax: Email: navalin@tbzmed.ac.ir Web page address: http://alzahrahosp.tbzmed.ac.ir
Protocol summary
Study aim
comparison of ovulation triggering outcome using these two methods: standard dose of human chorionic gonadotropin and human chorionic gonadotropin In combination with gonadotropin releasing hormone in IVF/ICSI cycles
Design
This will be a two arm parallel group design of 100 patients candidate of IVF/ICSI , single blind randomised trial, with a computer-generated randomization list with a block size of 4, with 1:1 allocation.
Settings and conduct
Infertile women candidates of IVF/ICSI for different reason, having the study criteria who come to infertility clinic of Alzahra hospital will be entered into the study. ّFirst we will take an informed written consent and all part of the study will be explained to the patient. The treatment allocation will be placed in a sealed opaque envelope and picked up consecutively.
Participants/Inclusion and exclusion criteria
women who are candidate of IVF/ICSI and have some risk of ovarian hyperstimulation syndrome (OHSS) will be entered in the study. Every body who has diminished ovarian reserve [antral folicular count (AFC) less than 4 or anti-mulerian hormone (AMH) less than 1] will be excluded.
Intervention groups
during ovarian stimulation and ultrasound control when there is at least 5 or more follicles above 17 mm in diameter we administer 0.2 mg decapeptide and 2500 unit HcG for triggering ovulation in the study group or 2 ampoules of 5000 unit HcG equivalent to 10,000 units HcG in the control group.
Main outcome variables
number and quality of oocytes؛ number and quality of embryos؛ fertilization rate؛ imlantation rate؛ the rate of OHSS
General information
Reason for update
increment of the sample size and change in the dose of the drug in the control and intervention group because of the mistake in typing
Acronym
IRCT registration information
IRCT registration number:IRCT20101227005485N7
Registration date:2019-07-18, 1398/04/27
Registration timing:registered_while_recruiting
Last update:2022-02-22, 1400/12/03
Update count:1
Registration date
2019-07-18, 1398/04/27
Registrant information
Name
Nazli Navali
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Medecine
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 2879
Email address
navalin@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of ovulation triggering outcome using these two methods: standard dose of human chorionic gonadotropin and human chorionic gonadotropin In combination with gonadotropin releasing hormone in IVF/ICSI cycles
Public title
comparison of standard dose of human chorionic gonadotropin and human chorionic gonadotropin In combination with gonadotropin releasing hormone in IVF/ICSI cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women who are candidate of IVF/ICSI and have some risk of OHSS will be entered in the study.
Exclusion criteria:
every body who have diminished ovarian reserve. (AFC<4 or AMH<1)
Age
From 20 years old to 40 years old
Gender
Female
Phase
4
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
A computer-generated randomization list with a block size of 4, with 1:1 allocation will be used to randomize patients. In such a case, one control will be checked for each intervention and with each of the 4 patients enrolled in the study, the two groups are balanced in terms of control and intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
The treatment allocation will be placed in a sealed, opaque, envelope and picked up consecutively. in the manner that the participant, the outcome evaluator and the analyzer will not be aware of the type of the drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research Deputy of Tabriz University of Medical Sciences, University of Tabriz, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.TBZMED.REC.1398.129
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
number and quality of resulted oocytes
Timepoint
the day of oocytes pick up
Method of measurement
microscopic evaluation
2
Description
fertilization rate
Timepoint
24 hours after intra-cytoplasmic sperm injection
Method of measurement
microscope
3
Description
implantation rate
Timepoint
2 weeks after embryo transfer
Method of measurement
Measurement of beta-hCG
4
Description
number and quality of embryos
Timepoint
after 24 hours, day 3 and day 5
Method of measurement
microscopic evaluation
Secondary outcomes
1
Description
ovarian hyperstimulation syndrome
Timepoint
the day of oocyte pick-up and a week later
Method of measurement
history, physical examination and laboratory tests
Intervention groups
1
Description
Intervention group: 2500 unit human chorionic gonadotropin In combination with 0.2 miligram gonadotropin releasing hormone
Category
Treatment - Drugs
2
Description
Control group: 10000 unit human chorionic gonadotropin for triggering
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Navali Nazli
Street address
south Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Web page address
http://alzahrahosp.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Elahe Saheb Olad Madarek
Street address
Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Web page address
http://alzahrahosp.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
infertility fellowship/associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Artesh street, Alzahra Hospita, infertility department
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
associate professor/infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility department, Alzahra Hospital, Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
associate professor/infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility department, Alzahra Hospital, Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
only a part of data could be shared
When the data will become available and for how long
2 years after publishing the results, the data could be attained.
To whom data/document is available
data will be given for every academic person who is interested in this field.
Under which criteria data/document could be used
for utilization in researches like in metha-analyses
From where data/document is obtainable
the applicants can mail there request to the person responsible for scientific inquiries.
What processes are involved for a request to access data/document
after application, data will be sent in two weeks.