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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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History
# Registration date Revision Id
3 2024-12-19, 1403/09/29 324371
2 2024-12-16, 1403/09/26 324130
1 2024-01-30, 1402/11/10 293089
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  • Protocol summary

    Evaluation and comparison of GnRH antagonist versus long GnRH agonist protocol in poor responders undergoing IVF
    comparison of GnRH antagonist versus long GnRH agonist protocol in poor responders undergoing IVF
    بررسی ومقایسه پروتکل اگونیست طولانی اثر GnRH و پروتکل انتاگونیست GnRHدرتحریک کنترل شده تخمدان در لقاح آزمایشگاهی در زنان نابارور با پاسخ ضعیف تخمدان
    مقایسه پروتکل اگونیست طولانی اثر GnRH و پروتکل انتاگونیست GnRHدرتحریک کنترل شده تخمدان در لقاح آزمایشگاهی در زنان نابارور با پاسخ ضعیف تخمدان
    Women aged 18 to 45 with poor ovarian response are candidates for ART without severe endometriosis, pelvic neoplasia, and severe male factor infertility.
    Women aged 18 to 42 with poor ovarian response are candidates for ART without severe endometriosis and severe male factor infertility.
    زنان18تا45سال با پاسخ ضعیف تخمدان کاندید ART که اندومتریوز شدید، نئوپلازی لگنی و نازایی با فاکتور مردانه شدید ندارند
    زنان18تا42سال با پاسخ ضعیف تخمدان کاندید ART که اندومتریوز شدید، و نازایی با فاکتور مردانه شدید ندارند
    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 12-14 mm, steroid will be prescribed daily and will continue until the day of the trigger.
    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.
    هر دو گروه ازبیماران پاسخ دهنده ضعیف کاندید ART انتخاب خواهند شد.که در روز دوم سیکل قاعدگی، سونوگرافی انجام و گنادوتروپین rFSH روزانه تزریق خواهد شد.در گروه اگونیست یک دوز دپو GnRH را به صورت عضلانی از روز21 سیکل قبل از تحریک تخمدان دریافت کردند. گروه انتاگونیست در صورت وجود فولیکول غالب 12-14 میلی متری، ستروتاید روزانه تجویز شده و تا روز تریگر ادامه خواهد داشت.
    هر دو گروه ازبیماران پاسخ دهنده ضعیف کاندید ART انتخاب خواهند شد.که در روز دوم سیکل قاعدگی، سونوگرافی انجام و گنادوتروپین rFSH روزانه تزریق خواهد شد.در گروه اگونیست یک دوز دپو GnRH را به صورت عضلانی از روز21 سیکل قبل از تحریک تخمدان دریافت کردند. گروه انتاگونیست در صورت وجود فولیکول غالب14 میلی متری، ستروتاید روزانه تجویز شده و تا روز تریگر ادامه خواهد داشت.
    The average number of injectable steroid ampoules, 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
    , 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
    تعداد امپول های تزریقی ستروتاید، تعداد اووسیت های بدست امده، تعداد امبریوهای بدست امده با کیفیت های A,B,C، دوز گنادوتروپین مصرف شده، طول دوره تحریک تخمدان، بارداری کلینیکی
    تعداد اووسیت های بدست امده، تعداد امبریوهای بدست امده با کیفیت های A,B,C، دوز گنادوتروپین مصرف شده، طول دوره تحریک تخمدان، بارداری کلینیکی

  • General information

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    2024-07-22, 1403/05/01
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    2024-10-31, 1403/08/10
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    خاتمه کارازمایی بالینی و بروز رسانی اطلاعات
    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 45
    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
    افراد کاندید IVF/ICSI
    زنان پاسخ دهنده ضعیف به تحریک تخمک گذاری:ذخیره تخمدان کمتر از1.2نانوگرم بر میلی لیتروتعدادAFC کمتر از5 گروهPOSEIDON3-4
    خانم های بین سن 18 تا 45 سال
    افراد کاندید IVF/ICSI
    زنان پاسخ دهنده ضعیف به تحریک تخمک گذاری:ذخیره تخمدان کمتر از1.2نانوگرم بر میلی لیتروتعدادAFC کمتر از5 گروهPOSEIDON3-4
    خانم های بین سن 18 تا 42 سال
    Asherman's history
    Severe uterine adenomyosis
    Egg donation cycles
    Cases of severe male infertility (azoospermia)
    Cases where surrogacy is used
    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)
    سابقه آشرمن شدید
    آدنومیوز شدید رحمی
    سیکل های اهدای تخمک
    موارد نازایی مردانه شدید(آزواسپرمی)
    مواردی که از رحم اجاره ای استفاده شده است
    سابقه آشرمن شدید
    آدنومیوز شدید رحمی
    سیکل های اهدای تخمک
    موارد نازایی مردانه شدید(آزواسپرمی)
    مواردی که از رحم اجاره ای استفاده شده است
    بیماری های اندوکرین یا متابولیک(کم کاری تیرویید ، پرکاری تیرویید)

  • Intervention groups

    #1
    The GnRH antagonist group will start from the second day of the menstrual cycle, the ultrasound of gonadotropin IU300 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 at most 3 follicles ≥17 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 a risk of OHSS or serum progesterone level ≥ 1.5ng/ml, all embryos will be frozen.
    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.
    گروه انتاگونیست GnRH از روز دوم سیکل قاعدگی ، سونوگرافی انجام وگنادوتروپین IU300 rFSH سینال-اف روزانه تزریق زیر جلدی شروع خواهد شد. سپس در صورت وجود فولیکول غالب ≥ 14 میلی متری، آنتاگونیست GNRH Cetrotide 0.25 mg) )تجویز شده و تا روز تریگرتخمک گذاری ادامه خواهد داشت. با مانیتورینگ سونوگرافی زمانی که حداکثر 3 فولیکول ≥17میلمتری داشته باشد،جهت القای بلوغ نهایی فولیکول در همان روز 10000واحد HCGتزریق شد.ضخامت آندومتر و سطح سرمی E2برای همه اندازه گیری شد34-36 ساعت پس از تریگر تحت بیهوشی عمومی وگاید سونوگرافی پانکچر تخمدان انجام خواهد شد. 72ساعت پس از پانکچر تخمدان، دو امبریو سه روزه ترانسفر وبقیه جنین ها فریز خواهند شد. در صورت وجود ریسک OHSS یا سطح پروژسترون سرمی≥ 1.5ng/ml تمامی جنین ها فریز خواهند شد.
    گروه انتاگونیست GnRH از روز دوم سیکل قاعدگی ، سونوگرافی انجام وگنادوتروپین IU225-300 rFSH سینال-اف روزانه تزریق زیر جلدی شروع خواهد شد. سپس در صورت وجود فولیکول غالب ≥ 14 میلی متری، آنتاگونیست GNRH Cetrotide 0.25 mg) )تجویز شده و تا روز تریگرتخمک گذاری ادامه خواهد داشت. با مانیتورینگ سونوگرافی زمانی که متوسط فولیکول ≥17میلمتری یا یک فولیکول 18داشته باشد،جهت القای بلوغ نهایی فولیکول در همان روز 10000واحد HCGتزریق شد.ضخامت آندومتر و سطح سرمی E2برای همه اندازه گیری شد34-36 ساعت پس از تریگر تحت بیهوشی عمومی وگاید سونوگرافی پانکچر تخمدان انجام خواهد شد. 72ساعت پس از پانکچر تخمدان، دو امبریو سه روزه ترانسفر وبقیه جنین ها فریز خواهند شد. در صورت سطح پروژسترون سرمی≥ 1.5ng/ml تمامی جنین ها فریز خواهند شد.
    #2
    Intervention group: In the GnRH agonist long protocol group, they received a 3.75 mg decapeptyl dose of GnRH depot analog intramuscularly from day 21 of the cycle before ovarian stimulation. From the second day of the menstrual cycle, the ultrasound of gonadotropin IU300 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, when a maximum of 3 follicles ≥17 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 a risk of OHSS or serum progesterone level ≥ 1.5ng/ml, all embryos will be frozen.
    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.
    در گروه پروتکل طولانی اگونسیتGnRH یک دوز دکاپپتیل3.75میلی گرم آنالوگ دپو GnRH را به صورت عضلانی از روز21 سیکل قبل از تحریک تخمدان دریافت کردند. از روز دوم سیکل قاعدگی ، سونوگرافی انجام وگنادوتروپین IU300 rFSH سینال-اف روزانه تزریق زیر جلدی شروع خواهد شد.برحسب پاسخ دهی تخمدان دوز دارو تنظیم می شود و تا روز تریگرتخمک گذاری ادامه خواهد داشت.با مانیتورینگ سونوگرافی زمانی که حداکثر 3 فولیکول ≥17میلمتری داشته باشد،جهت القای بلوغ نهایی فولیکول در همان روز 10000واحد HCGتزریق شد.ضخامت آندومتر و سطح سرمی E2برای همه اندازه گیری شد34-36 ساعت پس از تریگر تحت بیهوشی عمومی وگاید سونوگرافی پانکچر تخمدان انجام خواهد شد. 72ساعت پس از پانکچر تخمدان، دو امبریو سه روزه ترانسفر وبقیه جنین ها فریز خواهند شد. در صورت وجود ریسک OHSS یا سطح پروژسترون سرمی≥ 1.5ng/ml تمامی جنین ها فریز خواهند شد.
    در گروه پروتکل طولانی اگونسیتGnRH یک دوز زولادکس3.6میلی گرم آنالوگ دپو GnRH را به صورت زیرجلدی از روز21 سیکل قبل از تحریک تخمدان دریافت کردند. از روز دوم سیکل قاعدگی ، سونوگرافی انجام وگنادوتروپین IU300-225 rFSH سینال-اف روزانه تزریق زیر جلدی شروع خواهد شد.برحسب پاسخ دهی تخمدان دوز دارو تنظیم می شود و تا روز تریگرتخمک گذاری ادامه خواهد داشت.با مانیتورینگ سونوگرافی زمانی که متوسط فولیکول ≥17میلمتری یا یک فولیکول 18داشته باشدجهت القای بلوغ نهایی فولیکول در همان روز 10000واحد HCGتزریق شد.ضخامت آندومتر و سطح سرمی E2برای همه اندازه گیری شد34-36 ساعت پس از تریگر تحت بیهوشی عمومی وگاید سونوگرافی پانکچر تخمدان انجام خواهد شد. 72ساعت پس از پانکچر تخمدان، دو امبریو سه روزه ترانسفر وبقیه جنین ها فریز خواهند شد. در صورت سطح پروژسترون سرمی≥ 1.5ng/ml تمامی جنین ها فریز خواهند شد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Yazd Reproductive Sciences Institute
    Name of recruitment center - Persian: پژوهشکده علوم تولید مثل یزد
    Full name of responsible person - English: zahra amini majomerd
    Full name of responsible person - Persian: زهراامینی مجومرد
    Street address - English: Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
    Street address - Persian: یزد ، صفائیه ، خیابان بوعلی ، پژوهشکده علوم تولید مثل یزد
    City - English: yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: ۸۹۱۶۸۷۷۳۹۱
    Phone: +98 35 3824 7085
    Fax:
    Email: info@Yazd-RSI.ir
    Web page address:
    Name of recruitment center - English: Yazd Reproductive Sciences Institute
    Name of recruitment center - Persian: پژوهشکده علوم تولید مثل یزد
    Full name of responsible person - English: Zahra Amini Majomerd
    Full name of responsible person - Persian: زهراامینی مجومرد
    Street address - English: Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
    Street address - Persian: یزد ، صفائیه ، خیابان بوعلی ، پژوهشکده علوم تولید مثل یزد
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: ۸۹۱۶۸۷۷۳۹۱
    Phone: +98 35 3824 7085
    Fax:
    Email: info@Yazd-RSI.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amin Salehi Abargouei
    Full name of responsible person - Persian: امین صالحی ابرقویی
    Street address - English: Bahonar Ave
    Street address - Persian: خیابان باهنر
    City - English: yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3726 3733
    Fax:
    Email: dvc.research@ssu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amin Salehi Abargouei
    Full name of responsible person - Persian: امین صالحی ابرقویی
    Street address - English: Bahonar Ave
    Street address - Persian: خیابان باهنر
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3726 3733
    Fax:
    Email: dvc.research@ssu.ac.ir
    Web page address:

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: 2024-12-16, 1403/09/26
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
The number of embryos with qualities of A,B,or C
Timepoint
En 1-2 days after ovarian puncture
Method of measurement
Microscopic manual counting by embryologist

2

Description
En The duration of controlled ovarian stimulation period
Timepoint
Immediatly after controlled ovarian stimulation
Method of measurement
Time scale(day)

3

Description
The dosage of Gonadotropin used
Timepoint
After controlled ovarian stimulation
Method of measurement
Counting

4

Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
pregnancy test

5

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.
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