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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Primary outcomes
#1
ongoing pregnancy
Clinical pregnancy rate
ongoingClinical pregnancy rate
موارد باداری
میزان حاملگی بالینی
موارد باداریمیزان حاملگی بالینی
15-21 weeks after drug initiation
Observation of at least one fetus with cardiac activity at 4-6 weeks after embryo transfer in vaginal ultrasound
15Observation of at least one fetus with cardiac activity at 4-216 weeks after drug initiationembryo transfer in vaginal ultrasound
15تا 21هفته از شروع دارو
مشاهده حداقل یک جنین با فعالیت قلبی در 4-6 هفته پس از انتقال جنین در سونوگرافی واژینال
15تا 21هفتهمشاهده حداقل یک جنین با فعالیت قلبی در 4-6 هفته پس از شروع داروانتقال جنین در سونوگرافی واژینال
Medical examination and ultrasound
Vaginal ultrasound
Medical examination andVaginal ultrasound
معاینه و سونوگرافی
سونوگرافی واژینال
معاینه و سونوگرافی واژینال
Secondary outcomes
#1
empty
Live birth rate
Live birth rate
empty
میزان تولد زنده
میزان تولد زنده
empty
The delivery of a fetus who shows evidence of life after that is entirely outside of the mother
The delivery of a fetus who shows evidence of life after that is entirely outside of the mother
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زایمان جنینی که شواهدی از زندگی پس از خارج کامل از بدن مادر نشان می دهد.
زایمان جنینی که شواهدی از زندگی پس از خارج کامل از بدن مادر نشان می دهد.
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Delivery report from hospital
Delivery report from hospital
empty
گزارش زایمان از بیمارستان
گزارش زایمان از بیمارستان
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 possibility of side effects, the dose of progesterone was reduced to 100 mg/day in the method section and due to different responses patients, 7-14 days between the second dose of diphereline to hormone therapy, and 10-14 days from the day of estradiol to endometrial thickness evaluation were considered.
Acronym
IRCT registration information
IRCT registration number:IRCT20090526001952N13
Registration date:2020-12-24, 1399/10/04
Registration timing:registered_while_recruiting
Last update:2022-11-07, 1401/08/16
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 ,
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
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:
130
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
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
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?