Evaluation and comparison of GnRH antagonist versus long GnRH agonist protocol in poor responders undergoing IVF from POSEIDON group3- 4: A randomized clinical trial
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Secondary outcomes
#1
The number of embryos with qualities of A,B,or C
rate of early abortion
The numberrate of embryos with qualities of A,B,or Cearly abortion
تعداد امبریو های بدست آمده با کیفیت A, B , C
میزان سقط زودرس
تعداد امبریو های بدست آمده با کیفیت A, B , Cمیزان سقط زودرس
En 1-2 days after ovarian puncture
the loss of the gestational sac or fetal heartbeat in clinically pregnant individuals prior to 8 weeks of gestational age
En 1-2 days after ovarian puncturethe loss of the gestational sac or fetal heartbeat in clinically pregnant individuals prior to 8 weeks of gestational age
1-2روز بعداز پونکسیون تخمدان
از دست دادن کیسه حاملگی یا ضربان قلب جنین در افراد باردار بالینی قبل از 8 هفته سن بارداری
1-2روز بعداز پونکسیون تخمداناز دست دادن کیسه حاملگی یا ضربان قلب جنین در افراد باردار بالینی قبل از 8 هفته سن بارداری
Microscopic manual counting by embryologist
sonography
Microscopic manual counting by embryologistsonography
شمارش دستی زیر میکروسکوپ توسط جنین شناس
سونوگرافی
شمارش دستی زیر میکروسکوپ توسط جنین شناسسونوگرافی
#2
En The duration of controlled ovarian stimulation period
نرخ حاملگی مداوم
En The duration of controlled ovarian stimulation periodنرخ حاملگی مداوم
طول دوره تحریک تخمدان
ongoing pregnancy rate
طول دوره تحریک تخمدانongoing pregnancy rate
Immediatly after controlled ovarian stimulation
the continuation of pregnancy after 12 wk of gestational age.
Immediatlythe continuation of pregnancy after controlled ovarian stimulation12 wk of gestational age.
بلافاصله پس ازاتمام سیکل تحریک کنترل شده تخمدان
ادامه بارداری بعد از 12 هفته بارداری
بلافاصله پس ازاتمام سیکل تحریک کنترل شده تخمدانادامه بارداری بعد از 12 هفته بارداری
Time scale(day)
sonography
Time scale(day)sonography
مقیاس زمانی ( روز)
سونوگرافی
مقیاس زمانی ( روز)سونوگرافی
#3
The dosage of Gonadotropin used
Chemical pregnancy
The dosage of Gonadotropin usedChemical pregnancy
دوز گنادوتروپین مصرف شده
بارداری شیمیایی
دوز گنادوتروپین مصرف شدهبارداری شیمیایی
After controlled ovarian stimulation
2 weeks after embryo transfer
After controlled ovarian stimulation2 weeks after embryo transfer
بعد از اتمام سیکل تحریک کنترل شده تخمدان
2هفته بعد از انتقال جنین
2هفته بعد از اتمام سیکل تحریک کنترل شده تخمدانانتقال جنین
Counting
pregnancy test
Countingpregnancy test
شمارش
تست حاملگی
شمارشتست حاملگی
#4
Chemical pregnancy
Implantation
Chemical pregnancyImplantation
بارداری شیمیایی
لانه گزینی
بارداری شیمیاییلانه گزینی
2 weeks after embryo transfer
After a positive pregnancy test
2 weeks after embryo transferAfter a positive pregnancy test
2هفته بعد از انتقال جنین
بعد از مثبت شدن تست حاملگی
2هفته بعد از انتقال جنینمثبت شدن تست حاملگی
pregnancy test
sonography
pregnancy testsonography
تست حاملگی
سونوگرافی
تست حاملگیسونوگرافی
#5
Implantation
empty
Implantation
لانه گزینی
empty
لانه گزینی
After a positive pregnancy test
empty
After a positive pregnancy test
بعد از مثبت شدن تست حاملگی
empty
بعد از مثبت شدن تست حاملگی
sonography
empty
sonography
سونوگرافی
empty
سونوگرافی
Protocol summary
Study aim
comparison of GnRH antagonist versus long GnRH agonist protocol in poor responders undergoing IVF
Design
The phase 3 clinical trial, with a control group, will be conducted in parallel on 170 patients. The randomization of the samples will be done with Weber's simple randomization method according to the generated list of random numbers. The list of random numbers will be generated using the Random Allocation 1 software by A statistical consultant will be produced.
Settings and conduct
This study is conducted by the clinical trial method in Yazd Research Institute of Reproductive Sciences. The studied and control cases will be selected from among the people with poor ovarian response referring to the infertility clinic who are candidates for assisted reproductive methods. People who meet the inclusion criteria will be randomly assigned to two Gnrh agonist and Gnrh antagonist groups in the cycle of controlled ovarian stimulation.
Participants/Inclusion and exclusion criteria
Women aged 18 to 42 with poor ovarian response are candidates for ART without severe endometriosis and severe male factor infertility.
Intervention groups
Both groups of weakly responding patients who are candidates for ART will be selected. On the second day of the menstrual cycle, ultrasound will be performed and rFSH gonadotropin will be injected daily. In the agonist group, they will receive a depot dose of GnRH intramuscularly from the 21st day of the cycle before ovarian stimulation. . In the antagonist group, if there is a dominant follicle of 14 mm, steroid will be prescribed daily and will continue until the day of the trigger.
Main outcome variables
, the number of oocytes obtained, the number of embryos obtained with the qualities of A, B, C, the dose of gonadotropin used, the length of the ovarian stimulation periodو clinical pregnancy
General information
Reason for update
Termination of the test and completion of information
Acronym
IRCT registration information
IRCT registration number:IRCT20110509006420N28
Registration date:2024-01-30, 1402/11/10
Registration timing:prospective
Last update:2024-12-19, 1403/09/29
Update count:2
Registration date
2024-01-30, 1402/11/10
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
2024-01-30, 1402/11/10
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
2024-01-31, 1402/11/11
Actual recruitment end date
2024-07-22, 1403/05/01
Trial completion date
2024-10-31, 1403/08/10
Scientific title
Evaluation and comparison of GnRH antagonist versus long GnRH agonist protocol in poor responders undergoing IVF from POSEIDON group3- 4: A randomized clinical trial
Public title
Evaluation of GnRH long-acting agonist protocols and GnRH antagonist protocol in controlled ovarian stimulation in in vitro fertilization in infertile women with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
IVF/ICSI candidates
Women who respond poorly to ovulation stimulation: ovarian reserve less than 1.2 ng/ml and AFC number less than 5 POSEIDON group 3-4
Women between the ages of 18 and 42
Exclusion criteria:
sever Asherman's history
Severe uterine adenomyosis
Egg donation cycles
Cases of severe male infertility (azoospermia)
Cases where surrogacy is used
Endocrine or metabolic diseases (hypothyroidism, hyperthyroidism)
Age
From 18 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
170
Actual sample size reached:
170
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, using the simple randomization method using the Random Allocation1 software (http://random-allocation software.informer.com\1) and based on the simple randomization method, the list of samples in the two groups studied by the expert Statistics will be generated. In this software, in order to generate a list of random numbers, first specify the number of groups to be studied as 2 and the total number of samples required as 170 people, and then from the list of sample randomization methods, the method (simple randomization method in parallel group) by considering the same number of samples in the groups. Then a random list will be generated based on the groups and the number of samples in each group. Randomly and after obtaining informed consent by the researcher, they are assigned to two groups. The sealed envelope method is used for concealment. The envelopes are prepared as many samples as each envelope contains the name of the intervention group for each sample. Is.
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 Yazd reproductive Sience Institute- Shahid Sadoghi University of Medical Science
Street address
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Approval date
2024-01-10, 1402/10/20
Ethics committee reference number
IR.SSU.RSI.REC.1402.019
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
sonography
Secondary outcomes
1
Description
rate of early abortion
Timepoint
the loss of the gestational sac or fetal heartbeat in clinically pregnant individuals prior to 8 weeks of gestational age
Method of measurement
sonography
2
Description
نرخ حاملگی مداوم
Timepoint
the continuation of pregnancy after 12 wk of gestational age.
Method of measurement
sonography
3
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
pregnancy test
4
Description
Implantation
Timepoint
After a positive pregnancy test
Method of measurement
sonography
Intervention groups
1
Description
The GnRH antagonist group will start from the second day of the menstrual cycle, the ultrasound of gonadotropin IU225-300 rFSH signal-F daily subcutaneous injection. Then, if there is a dominant follicle ≥ 14 mm, the GNRH antagonist (Cetrotide 0.25 mg) is prescribed and will continue until the ovulation trigger day. With ultrasound monitoring, when there are The average follicle is ≥17 mm or one follicle is 18 mm, 10,000 hCG units were injected to induce the final maturation of follicles on the same day. Endometrial thickness and serum E2 level were measured for all 34-36 hours after the trigger under general anesthesia and ovarian puncture will be performed by ultrasound. became. 72 hours after ovarian puncture, two three-day-old embryos will be transferred and the remaining embryos will be frozen. If there is serum progesterone level ≥ 1.5ng/ml, all embryos will be frozen.
Category
Treatment - Drugs
2
Description
Intervention group: In the GnRH agonist long protocol group, they received a zoladex 3.6 mg dose of GnRH depot analog sc from day 21 of the cycle before ovarian stimulation. From the second day of the menstrual cycle, the ultrasound of gonadotropin IU225-300 rFSH signal-F will be injected daily subcutaneously. The dose of the drug will be adjusted according to the response of the ovary and will continue until the ovulation trigger day. With ultrasound monitoring, whenThe average follicle is ≥17 mm or one follicle is 18 mm In order to induce the final maturation of the follicle, 10,000 units of HCG were injected on the same day. Endometrial thickness and E2 serum level were measured for all 34-36 hours after the trigger under general anesthesia and ovarian puncture will be performed under ultrasound guidance. 72 hours after ovarian puncture, two three-day-old embryos will be transferred and the remaining embryos will be frozen. If there is serum progesterone level ≥ 1.5ng/ml, all embryos will be frozen.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Institute
Full name of responsible person
Zahra Amini Majomerd
Street address
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
info@Yazd-RSI.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Bahonar Ave
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
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
professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
City
yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
eftekhar@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
maryam eftekhar
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
City
yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
eftekhar@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
maryam eftekhar
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
City
yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
eftekhar@ssu.ac.ir
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
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
Undecided - It is not yet known if there will be 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
All participant data sets are to be shared
When the data will become available and for how long
2 months after the result publication
To whom data/document is available
In order to receive data or other study documents, researchers working in academic and scientific institutions are allowed to apply
Under which criteria data/document could be used
To evaluate the accuracy of the data and use data to complete other researches
From where data/document is obtainable
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran
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.