Comparison the pregnancy outcomes in patients with adenomyosis after pitutary down-regulation with GnRHagonist plus hormone replacement therapy versus HRT for endometrial preparation in frozen embryo transfer cycles
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General information
130
140
130140
The English translation of the third entry criterion was not exactly the same as the Persian part, so the English part was modified.
Due to the fact that the rate of chemical pregnancy, the rate of miscarriage, and the rate of twins pregnancy have also been investigated and followed up, therefore, they were added in the primary and secondary results section.
The English translationDue to the fact that the rate of the third entry criterion was not exactlychemical pregnancy, the same asrate of miscarriage, and the Persian partrate of twins pregnancy have also been investigated and followed up, sotherefore, they were added in the English part was modifiedprimary and secondary results section.
ترجمه انگلیسی سومین معیار ورود کاملا مشابه بخش فارسی نبوده است لذا قسمت انگلیسی اصلاح شد.
با توجه به اینکه میزان حاملگی کمیکال و میزان سقط و میزان دوقلویی نیز بررسی و پیگیری شده است لذا در قسمت نتایج اولیه و ثانویه اضافه گردید.
ترجمه انگلیسی سومین معیار ورود کاملا مشابه بخش فارسی نبودهبا توجه به اینکه میزان حاملگی کمیکال و میزان سقط و میزان دوقلویی نیز بررسی و پیگیری شده است لذا در قسمت انگلیسی اصلاح شدنتایج اولیه و ثانویه اضافه گردید.
Our sample size is 130people, with 65people in each group. The Block randomization method was designed by the epidemiologist using STATA version . 13 software. The kind of treatment will put in the pocket. When the doctor confirmed the eligibility of the patient the midwife will give the pocket to the doctor.
Our sample size is 140 people, with 70 people in each group. The Block randomization method was designed by the epidemiologist using STATA version . 13 software. The kind of treatment will put in the pocket. When the doctor confirmed the eligibility of the patient the midwife will give the pocket to the doctor.
Our sample size is 130people140 people, with 65people70 people in each group. The Block randomization method was designed by the epidemiologist using STATA version . 13 software. The kind of treatment will put in the pocket. When the doctor confirmed the eligibility of the patient the midwife will give the pocket to the doctor.
حجم نمونه ما 130 نفر میباشد که 65 نفر در هر گروه قرار خواهند گرفت. روش تخصیص تصادفی بلوکی بوده که با استفاده از نرم افزار stata ورژن 13 توسط همکار اپیدمیولوژیست طراحی شد . نوع و توالی درمان در پاکت قرارداده می شود و زمانی که پزشک واجد شرایط بودن بیمار را تایید میکند، ماما ی بخش که از مطالعه خارج است پاکت درمان را به پزشک میدهد.
حجم نمونه ما 140 نفر میباشد که 70 نفر در هر گروه قرار خواهند گرفت. روش تخصیص تصادفی بلوکی بوده که با استفاده از نرم افزار stata ورژن 13 توسط همکار اپیدمیولوژیست طراحی شد . نوع و توالی درمان در پاکت قرارداده می شود و زمانی که پزشک واجد شرایط بودن بیمار را تایید میکند، ماما ی بخش که از مطالعه خارج است پاکت درمان را به پزشک میدهد.
حجم نمونه ما 130140 نفر میباشد که 6570 نفر در هر گروه قرار خواهند گرفت. روش تخصیص تصادفی بلوکی بوده که با استفاده از نرم افزار stata ورژن 13 توسط همکار اپیدمیولوژیست طراحی شد . نوع و توالی درمان در پاکت قرارداده می شود و زمانی که پزشک واجد شرایط بودن بیمار را تایید میکند، ماما ی بخش که از مطالعه خارج است پاکت درمان را به پزشک میدهد.
Primary outcomes
#1
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Chemical pregnancy rate
Chemical pregnancy rate
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میزان حاملگی کمیکال
میزان حاملگی کمیکال
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14 days after embryos transfer
14 days after embryos transfer
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14 روز پس از انتقال جنین
14 روز پس از انتقال جنین
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by using laboratory kits for blood Beta-hCG assay
by using laboratory kits for blood Beta-hCG assay
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با استفاده از کیتهای آزمایشگاهی برای اندازه گیری سطح خونی Beta-hCG
با استفاده از کیتهای آزمایشگاهی برای اندازه گیری سطح خونی Beta-hCG
Secondary outcomes
#1
empty
Miscarriage rate
Miscarriage rate
empty
میزان سقط
میزان سقط
empty
Before the 20th week of pregnancy
Before the 20th week of pregnancy
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قبل از هفته ی 20 حاملگی
قبل از هفته ی 20 حاملگی
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Ultrasound evidence of clinical pregnancy loss before 20 weeks of gestation
Ultrasound evidence of clinical pregnancy loss before 20 weeks of gestation
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شواهد سونوگرافی از دست دادن بارداری بالینی قبل از هفته 20 بارداری
شواهد سونوگرافی از دست دادن بارداری بالینی قبل از هفته 20 بارداری
#2
empty
Twin pregnancy rate
Twin pregnancy rate
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میزان حاملگی دو قلویی
میزان حاملگی دو قلویی
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6 to 7 weeks after embryo transfer
6 to 7 weeks after embryo transfer
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6 تا 7 هفته پس از انتقال جنین
6 تا 7 هفته پس از انتقال جنین
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observation of two gestational sacs along with the fetal poles with heart beat in ultrasound examination
observation of two gestational sacs along with the fetal poles with heart beat in ultrasound examination
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مشاهده دو ساک حاملگی همراه با قطبهای جنینی با ضربان قلب در سونوگرافی
مشاهده دو ساک حاملگی همراه با قطبهای جنینی با ضربان قلب در سونوگرافی
Protocol summary
Study aim
Comparison of two endometrial preparation protocols for frozen-thawed embryo transfer in patient with adenomyosis
Design
This study is designed as a randomized, single-blind clinical trial with parallel groups with a sample size of 65 individuals per group
Settings and conduct
This study will be done on 130 women with adenomyosis undergoing frozen embryo transfer. After random allocation, they will be treated withGnRH+HRT or HRT. Pregnancy outcomes will be assessed in both groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 30-45 Years First or second cycle of embryo transfer, Normal uterine cavity adenomyosis with or without endometriosis and myoma. Exclusion criteria: recurrent implantation failure, hydrosalpinx, uterine anomaly , sever male factor infertility myoma >5 cm sever endometriosis uterine distortion because of myoma
Intervention groups
Intervention group1: endometrial preparation with HRT+GnRHa
Intervention group2: endometrial preparation with HRT
Main outcome variables
chemical pregnancy and clinical pregnancy and ongoing pregnancy.
General information
Reason for update
Due to the fact that the rate of chemical pregnancy, the rate of miscarriage, and the rate of twins pregnancy have also been investigated and followed up, therefore, they were added in the primary and secondary results section.
Acronym
IRCT registration information
IRCT registration number:IRCT20090526001952N13
Registration date:2020-12-24, 1399/10/04
Registration timing:registered_while_recruiting
Last update:2023-01-03, 1401/10/13
Update count:4
Registration date
2020-12-24, 1399/10/04
Registrant information
Name
Ashraf Moini
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
hosp_arash@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the pregnancy outcomes in patients with adenomyosis after pitutary down-regulation with GnRHagonist plus hormone replacement therapy versus HRT for endometrial preparation in frozen embryo transfer cycles
Public title
Comparison of two endometrial preparation protocols for frozen-thawed embryo transfer in patient with adenomyosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30-45 Years
First or second cycle of embryo transfer
Presence of adenomyosis, either focal or generalized, with or without concomitant diagnosis of endometriosis and myoma
Normal uterine cavity
Exclusion criteria:
recurrent implantation failure,
hydrosalpinx,
uterine anomaly ,
sever male factor infertility
myoma >5 cm
sever endometriosis
uterine distortion because of myoma
Age
From 30 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Our sample size is 140 people, with 70 people in each group. The Block randomization method was designed by the epidemiologist using STATA version . 13 software. The kind of treatment will put in the pocket. When the doctor confirmed the eligibility of the patient the midwife will give the pocket to the doctor.
Blinding (investigator's opinion)
Single blinded
Blinding description
Because of the kind of intervention, The patient will be aware of the treatment. Outcomes assessor will not be informed about the kind of treatment A statistician who is unaware of the type of interventions in each group will analyze the data
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
Baghdarnia St.
City
Tehran
Province
Tehran
Postal code
1653915981
Approval date
2020-04-30, 1399/02/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.034
Health conditions studied
1
Description of health condition studied
Infertility in adenomyosis
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
Observation of at least one fetus with cardiac activity at 4-6 weeks after embryo transfer in vaginal ultrasound
Method of measurement
Vaginal ultrasound
2
Description
Chemical pregnancy rate
Timepoint
14 days after embryos transfer
Method of measurement
by using laboratory kits for blood Beta-hCG assay
Secondary outcomes
1
Description
Live birth rate
Timepoint
The delivery of a fetus who shows evidence of life after that is entirely outside of the mother
Method of measurement
Delivery report from hospital
2
Description
Miscarriage rate
Timepoint
Before the 20th week of pregnancy
Method of measurement
Ultrasound evidence of clinical pregnancy loss before 20 weeks of gestation
3
Description
Twin pregnancy rate
Timepoint
6 to 7 weeks after embryo transfer
Method of measurement
observation of two gestational sacs along with the fetal poles with heart beat in ultrasound examination
Intervention groups
1
Description
Control group: This group will received dipherelin (3.75 mg) On day 3 after LMP,and then repeat after28 days .7-14 days after second dose then estradiol valerate is administered at the dose of 2 mg and will be increased to 6 mg /daily. The patient will be examined after 10-14 days. An endometrial thickness of 8 mm or more is optimum for progesterone administration ,(an injectable progestron 100 mg /daily) otherwise the dose of estradiol will be increased up to 8 mg. If the optimal endometrial thickness is not achieved after 20 days, embryo transfer will be canceled.
Category
Treatment - Drugs
2
Description
Intervention group: This group will be received estradiol valerate (Aboureihan Co.). On day2 after LMP, estradiol valerate is administered at the dose of 2 mg and will be increased up to 6 mg. The patient will be examined after 10-14 days. An endometrial thickness of 8 mm or more is optimum for progesterone administration (ingectable progestron 100 mg/daily), otherwise the dose of estradiol will be increased up to 8 mg. If the optimal endometrial thickness is not achieved after 20 days, embryo transfer will be canceled.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
dr marzieh eslami moayed
Street address
Baghdarnia St.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
marzieh_moayed@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
Qods St,Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653911
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?