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Comparison of the effectiveness of GnRH agonist stop-Antagonist protocol versus GnRH antagonist protocol in poor respondent IVF candidate patients

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History
# Registration date Revision Id
2 2021-07-04, 1400/04/13 189049
1 2020-12-15, 1399/09/25 163194
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  • Protocol summary

    number of oocytes, M II oocytes, and embryos, chemical, and clinical pregnancy
    number of oocytes, M II oocytes, and embryos and embryo quality
    تعداد تخمک M II، تعداد فولیکول ها، تعداد جنین ها، بارداری شیمیایی و کلینیکی
    تعداد تخمک M II، تعداد تخمک، تعداد جنین ها، کیفیت جنین ها

  • General information

    2021-06-10, 1400/03/20
    2021-08-01, 1400/05/10
    empty
    Due to the prevalence of Covid-19 and the reluctance of most patients to transfer fresh embryos in the cycle has begun, so we faced a reduction in sample size, so we requested a change in the protocol to investigate the effect of these treatments on oocyte count ,oocyte quality and embryo quality regardless of pregnancy and pregnancy outcomes
    empty
    با سلام و احترام با توجه به شیوع کووید-19 و عدم تمایل اکثر بیماران به انتقال جنین فرش در سیکل شروع شده، لذا با کاهش حجم نمونه مواجه شدیم لذا درخواست تغییر پروتکل برای بررسی تاثیر این روش های درمانی بر کیفیت تخمک و جنین بدون در نظر گرفتن بارداری و سرانجام ان را داریم .

  • Primary outcomes

    #1
    Chemical pregnancy
    Number of mature oocytes
    بارداری شیمیایی
    تعداد اووسیت مچور
    14 days after embryo transfer
    During IVF process
    14 روز بعد از انتقال جنین
    در پروسهIVF
    bHCG blood test
    Embryologist opinion
    bhCG خون
    نظر جنین شناس
    #2
    Number of mature oocytes
    Number of mature oocytes at retrieval
    تعداد اووسیت مچور
    تعداد جنین به دست آمده
    در پروسهIVF
    در پروسه IVF
    #3
    Number of mature oocytes at retrieval
    empty
    تعداد جنین به دست آمده
    empty
    During IVF process
    empty
    در پروسه IVF
    empty
    Hospital record
    empty
    ثبت در پرونده
    empty

  • Secondary outcomes

    #1
    Clinical pregnancy
    Embryo quality
    بارداری کلینیکی
    کیفیت جنین
    In 5 weeks of pregnancy
    Embryo formation
    هفته 5 بارداری
    تشکیل جنین
    Transvaginal ultrasounds
    By the embryologist
    سونوگرافی ترانس واژینال
    توسط جنین شناس
    #2
    Ongoing pregnancy
    oocyte count
    بارداری 12 هفته
    تعداد اووسیت
    In 12 weeks of pregnancy
    Puncture Day
    هفته 12 بارداری
    روز پانکچر
    Ultrasounds
    by embryologist
    سونوگرافی
    جنین شناس

  • Intervention groups

    #1
    Intervention group: GnRH(0.1 mg/daily) will be injected from mid-luteal phase until mense then in the second day of menstrual cycle recombinant FSH with LH will be injected. When the size of the follicle reaches 13-14 mm, the GnRH antagonist will be injected until trigger day. When the size of the follicle will reach above 18 mm HCG will be injected and 36 hours later ovarian puncture will be performed. One to three embryos will be transferred on the third day and luteal phase support is performed with progesterone.
    Intervention group: GnRH(0.1 mg/daily) will be injected from mid-luteal phase until mense then in the second day of menstrual cycle recombinant FSH with LH will be injected. When the size of the follicle reaches 13-14 mm, the GnRH antagonist will be injected until trigger day. When the size of the follicle will reach above 18 mm HCG will be injected and 36 hours later ovarian puncture will be performed.
    گروه مداخله: شروع تزریق(0.1 mg/daily) GnRH agonist از میدلوئتال سیکل قاعدگی تا منس بیمار ادامه می یابد سپس در روز دوم سیکل پریود جهت بیمار گنادوتروپینrecombinant FSH به همراه LH شروع می شود وقتی سایز فولیکول به 13-14mm رسید آنتاگوسینت GnRH تا بلوغ نهایی اووسیت و روز تریگرHCG ادامه می یابد . زمانی که حداقل 2 فولیکول 18mm و بالاتر تریگر بود انجام می شود و 36ساعت پس از تریگر پانکچر می شود و یک تا سه جنین با گرید (A&B) روز سه و پنجم انتقال می یابد و ساپورت فاز لوتئال با شیاف پروژسترون انجام می شود.
    گروه مداخله: شروع تزریق(0.1 mg/daily) GnRH agonist از میدلوئتال سیکل قاعدگی تا منس بیمار ادامه می یابد سپس در روز دوم سیکل پریود جهت بیمار گنادوتروپینrecombinant FSH به همراه LH شروع می شود وقتی سایز فولیکول به 13-14mm رسید آنتاگوسینت GnRH تا بلوغ نهایی اووسیت و روز تریگرHCG ادامه می یابد . زمانی که حداقل 2 فولیکول 18mm و بالاتر تریگر بود انجام می شود و 36ساعت پس از تریگر پانکچر می شود .
    #2
    گروه دوم : تحریک تخمدان با گنادوتروپین از روز دوم پریود شروع می شود سپس رشد فولیکول با سونوی واژینال مانیتور می گردد. وقتی سایز فولیکول به 13-14mm رسید (0.25mg/daily) آنتاگوسینت GnRH شروع و تا زمان تریگر ادامه می یابد . زمان تریگرزمان بلوغ نهایی اووسیت می باشد یعنی حداقل 2 فولیکول 18mm و بالاتر تریگر انجام می شود و 36ساعت پس از تریگر پانکچر انجام شده و یک تا سه جنین با کیفیت گرید (A&B)روز سه و پنجم انتقال می یابد و ساپورت فاز لوتئال با شیاف پروژسترون (سیلکوژست 400mg/B/D )انجام می شود.
    گروه دوم : تحریک تخمدان با گنادوتروپین از روز دوم پریود شروع می شود سپس رشد فولیکول با سونوی واژینال مانیتور می گردد. وقتی سایز فولیکول به 13-14mm رسید (0.25mg/daily) آنتاگوسینت GnRH شروع و تا زمان تریگر ادامه می یابد . زمان تریگرزمان بلوغ نهایی اووسیت می باشد یعنی حداقل 2 فولیکول 18mm و بالاتر تریگر انجام می شود و 36ساعت پس از تریگر پانکچر انجام خواهد شد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Arash women's hospital
    Name of recruitment center - Persian: بیمارستان بانوان آرش
    Full name of responsible person - English: Dr.ladan Kashani
    Full name of responsible person - Persian: دکتر لادن کاشانی
    Street address - English: No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
    Street address - Persian: بزرگراه رسالت، بعد از اتوبان شهید باقری، خیابان شهید باغدارنیا(رشید شمالی)، جنب کلانتری ۱۲۶، نبش کوچه ۱۶۲ (شهید عبدالمجید)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1653915981
    Phone: +98 21 7788 3283
    Fax:
    Email: Kashani_ladan@tums.ac.ir
    Web page address: http://arash.tums.ac.ir/
    Name of recruitment center - English: Arash women's hospital
    Name of recruitment center - Persian: بیمارستان بانوان آرش
    Full name of responsible person - English: Dr.Ladan Kashani
    Full name of responsible person - Persian: دکتر لادن کاشانی
    Street address - English: No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
    Street address - Persian: بزرگراه رسالت، بعد از اتوبان شهید باقری، خیابان شهید باغدارنیا(رشید شمالی)، جنب کلانتری ۱۲۶، نبش کوچه ۱۶۲ (شهید عبدالمجید)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1653915981
    Phone: +98 21 7788 3283
    Fax:
    Email: Kashani_ladan@tums.ac.ir
    Web page address: http://arash.tums.ac.ir/

Protocol summary

Study aim
Comparison of the effectiveness of GnRH agonist stop-Antagonist protocol versus GnRH antagonist protocol on fertility outcomes in poor respondent IVF candidate patients
Design
This study is designed as a randomized, phase 3 clinical trial with parallel groups, and a sample size of 74 participants. The randomization method will be the block randomization method.
Settings and conduct
The study will be conducted at Arash Women's Hospital on all women undergoing IVF. Patients who signed informed consent will be randomly divided into two groups. The first group will receive the Agonist stop Antagonist porotocol and the other group received the GnRH Antagonist protocol. The random allocation and final outcome of the study will be assessed by a person who is unaware of the study process. Also, the statistician will be unaware of the study process
Participants/Inclusion and exclusion criteria
Inclusion criteria: The criteria for diagnosing poor ovarian response are two of the following:1- Age 40 or older 2 - History of poor ovarian response (POR) in the previous cycle (oocyte less than 3 in a conventional protocol), 3-Antral follicle count (AFC) less than 5-7 or Anti-Müllerian hormone (AMH) <0.5-1.1. In addition, twice poor ovarian response after maximal ovarian stimulation is sufficient reason to introduce the individual as POR without the need for other criteria. Exclusion criteria: Polycystic ovarian syndrome, Hypothalamic amenorrhea, Repeated IVF failure
Intervention groups
In the IVF process, the first group will receive the Agonist stop Antagonist protocol Group 2 will Receive the GnRH Antagonist protocol.
Main outcome variables
number of oocytes, M II oocytes, and embryos and embryo quality

General information

Reason for update
Due to the prevalence of Covid-19 and the reluctance of most patients to transfer fresh embryos in the cycle has begun, so we faced a reduction in sample size, so we requested a change in the protocol to investigate the effect of these treatments on oocyte count ,oocyte quality and embryo quality regardless of pregnancy and pregnancy outcomes
Acronym
IRCT registration information
IRCT registration number: IRCT20110731007165N10
Registration date: 2020-12-15, 1399/09/25
Registration timing: registered_while_recruiting

Last update: 2021-07-04, 1400/04/13
Update count: 1
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Ladan Kashani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 1866
Email address
kashani_ladan@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-10, 1399/09/20
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of GnRH agonist stop-Antagonist protocol versus GnRH antagonist protocol in poor respondent IVF candidate patients
Public title
Comparison of the effectiveness of GnRH agonist stop-Antagonist protocol versus GnRH antagonist protocol in IVF candidate patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The criteria for diagnosing poor ovarian response are two of the following:1- Age 40 or older 2 - History of poor ovarian response (POR) in the previous cycle (oocyte less than 3 in a conventional protocol), 3-Antral follicle count (AFC) less than 5-7 or Anti-Müllerian hormone (AMH) <0.5-1.1. Twice poor ovarian response after maximal ovarian stimulation is sufficient reason to introduce the individual as POR without the need for other criteria.
Exclusion criteria:
Polycystic ovarian syndrome Hypothalamic amenorrhea Uterine congenital anomalies and uterine cavity abnormalities (Bicorn uterus, Unicorn uterus, Asherman, Liomyuma, Polyp, etc.) Repeated IVF failure (more than three consecutive failures) Endocrine disorders (diabetes, thyroid disease, antipolipid syndrome, cardiovascular and liver disease),
Age
From 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization list will be prepared by a statistician using the block randomization method (using the site:www.sealedenvelope.com). Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained. Then the treatment will be performed based on the kind of treatment in the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-10-31, 1399/08/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.694

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 of mature oocytes
Timepoint
During IVF process
Method of measurement
Embryologist opinion

2

Description
Number of mature oocytes at retrieval
Timepoint
During IVF process
Method of measurement
Embryologist opinion

Secondary outcomes

1

Description
Embryo quality
Timepoint
Embryo formation
Method of measurement
By the embryologist

2

Description
oocyte count
Timepoint
Puncture Day
Method of measurement
by embryologist

Intervention groups

1

Description
Intervention group: GnRH(0.1 mg/daily) will be injected from mid-luteal phase until mense then in the second day of menstrual cycle recombinant FSH with LH will be injected. When the size of the follicle reaches 13-14 mm, the GnRH antagonist will be injected until trigger day. When the size of the follicle will reach above 18 mm HCG will be injected and 36 hours later ovarian puncture will be performed.
Category
Treatment - Drugs

2

Description
Group2:Ovarian stimulation with GnRH will be started from 2 days of the menstrual cycle. When the size of the follicle will reach above 13-14 mm GnRH antagonist (0.2 mg/daily) will be injected until trigger day. When the size of the follicle will reach above 18 mm HCG will be injected and 36 hours later ovarian puncture will be performed. One to three embryos will be transferred on the third day and luteal phase support is performed with progesterone.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Dr.Ladan Kashani
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
Kashani_ladan@tums.ac.ir
Web page address
http://arash.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraeyan
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ladan Kashani
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 8828 1866
Fax
+98 21 8895 2510
Email
kashani_ladan@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash Hospital, Rashid Street, Tehran Pars
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3195
Fax
Email
Kashani_ladan@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash Hospital, Rashid Street, Tehran Pars
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3195
Fax
Email
Kashani_ladan@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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
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