Comparison of fetal transfer results under abdominal ultrasound with fetal transfer based on previous measurement of uterine length with vaginal ultrasound in assisted reproductive cycles
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Protocol summary
Phase 3 clinical trial is with two parallel groups and the sample size is 260 people. Randomization will be done using random allocation1 software. Block randomization method will be done. Blinding will not be done.
A clinical trial with two parallel groups and a sample size of 260 people. Randomization will be done using random allocation1 software. Block randomization method will be done. Blinding will not be done.
Phase 3A clinical trial is with two parallel groups and thea sample size isof 260 people. Randomization will be done using random allocation1 software. Block randomization method will be done. Blinding will not be done.
کارآزمایی بالینی فاز 3 با دو گروه موازی و حجم نمونه 260 نفر است .تصادفی سازی با استفاده از نرم افزارrandom allocation1 روش تصادفی سازی بلوکی انجام خواهد شد.کور سازی انجام نمیشود.
کارآزمایی بالینی با دو گروه موازی و حجم نمونه 260 نفر است .تصادفی سازی با استفاده از نرم افزارrandom allocation1 روش تصادفی سازی بلوکی انجام خواهد شد.کور سازی انجام نمیشود.
کارآزمایی بالینی فاز 3 با دو گروه موازی و حجم نمونه 260 نفر است .تصادفی سازی با استفاده از نرم افزارrandom allocation1 روش تصادفی سازی بلوکی انجام خواهد شد.کور سازی انجام نمیشود.
It is a randomized clinical trial, with No blinding. Yazd Infertility Research Center was conducted.
It is done at Yazd Infertility Research Center.
It is a randomized clinical trial, with No blinding.done at Yazd Infertility Research Center was conducted.
کارآزمایی بالینی تصادفی بدون کورسازی است.در مرکز تحقیقات ناباروری یزد انجام شد.
کارآزمایی بالینی در مرکز تحقیقات ناباروری یزد انجام شد.
کارآزمایی بالینی تصادفی بدون کورسازی است.دردر مرکز تحقیقات ناباروری یزد انجام شد.
Chemical pregnancy, clinical pregnancy, abortion, implantation rate
Chemical pregnancy, clinical pregnancy, early abortion, implantation rate
Chemical pregnancy, clinical pregnancy, early abortion, implantation rate
Randomization will be done using random allocation 1 software, block randomization method. Each participant is given a number from 1 to 260 and then 9 blocks of 32 are considered and then each block is randomly selected. Randomization of samples in each block is independent, which is determined by the software, and researchers are not aware of the randomized list.
Each participant is assigned a number from 1 to 260, and then 9 blocks of 32 are considered, and then each block is randomly selected. In each block, the type of treatment protocol of the participants is determined. Randomization using software The random allocation 1 software will be a block randomization method. The randomization of samples in each block is independent, which is specified by the software, and the researchers do not know about the randomized list.
Randomization will be done using random allocation 1 software, block randomization method. Each participant is givenassigned a number from 1 to 260, and then 9 blocks of 32 are considered, and then each block is randomly selected. In each block, the type of treatment protocol of the participants is determined. Randomization using software The random allocation 1 software will be a block randomization method. The randomization of samples in each block is independent, which is determinedspecified by the software, and the researchers aredo not aware ofknow about the randomized list.
تصادفی سازی با استفاده از نرم افزارrandom allocation1 روش تصادفی سازی بلوکی انجام خواهد شد. به هر شرکت کننده یک شماره از 1 تا 260 تعلق میگیرد و سپس 9 بلوک 32 تایی در نظر گرفته می شوند و سپس هر بلوک به تصادف انتخاب می شود. تصادفی سازی نمونه ها در هر بلوک به صورت مستقل است که توسط نرم افزار مشخص میگردد و پژوهشگران از لیست تصادفی شده اطلاع ندارند.
به هر شرکت کننده یک شماره از 1 تا 260 تعلق میگیرد و سپس 9 بلوک 32 تایی در نظر گرفته می شوند و سپس هر بلوک به تصادف انتخاب می شود.در هر بلوک نوع پروتکل درمانی شرکت کنندگان مشخص میشود.تصادفی سازی با استفاده از نرم افزارrandom allocation1 روش تصادفی سازی بلوکی انجام خواهد شد.تصادفی سازی نمونه ها در هر بلوک به صورت مستقل است که توسط نرم افزار مشخص میگردد و پژوهشگران از لیست تصادفی شده اطلاع ندارند.
تصادفی سازی با استفاده از نرم افزارrandom allocation1 روش تصادفی سازی بلوکی انجام خواهد شد. به هر شرکت کننده یک شماره از 1 تا 260 تعلق میگیرد و سپس 9 بلوک 32 تایی در نظر گرفته می شوند و سپس هر بلوک به تصادف انتخاب می شود.شود.در هر بلوک نوع پروتکل درمانی شرکت کنندگان مشخص میشود.تصادفی سازی با استفاده از نرم افزارrandom allocation1 روش تصادفی سازی بلوکی انجام خواهد شد.تصادفی سازی نمونه ها در هر بلوک به صورت مستقل است که توسط نرم افزار مشخص میگردد و پژوهشگران از لیست تصادفی شده اطلاع ندارند.
Secondary outcomes
#1
Miscarriage rate
Early Miscarriage rate
Early Miscarriage rate
ميزان سقط
ميزان سقط زودرس
ميزان سقط زودرس
Loss of pregnancy before 20 gestational week
10 weeks after embryo transfer
Loss of pregnancy before 20 gestational week10 weeks after embryo transfer
فا از دست رفتن حاملگي قبل از هفته 20
10 هفته بعد از انتقال جنین
فا10 هفته بعد از دست رفتن حاملگي قبل از هفته 20انتقال جنین
Protocol summary
Study aim
The aim of this study was to compare two methods of embryo transfer in increasing implantation and pregnancy in assisted reproductive cycles
Design
A clinical trial with two parallel groups and a sample size of 260 people. Randomization will be done using random allocation1 software. Block randomization method will be done. Blinding will not be done.
Settings and conduct
It is done at Yazd Infertility Research Center.
Participants/Inclusion and exclusion criteria
Women 18 to 40 years old are candidates for frozen embryo transfer are included in the study , and cases of severe male infertility, including azoospermia and sperm from TESE or PESA, and a history of uterine surgery such as hysteroscopic surgery and a body mass index greater than 30 are excluded.
Intervention groups
The first intervention group receives 6 mg of oral estradiol daily from the second day of the cycle and on day 13 of the cycle, transvaginal ultrasound is performed. Embryo transfer takes place at the stage of 8-cell cleavage. The transfer is performed under the guidance of abdominal ultrasound.
The second intervention group receives 6 mg of oral estradiol from the second day of the cycle, and on the 13th cycle, transvaginal ultrasound is performed. Embryo transfer takes place in the 8-cell cleavage stage. Ultrasound measurement of uterine length is performed before transfer with vaginal ultrasound and the length of the catheter is adjusted based on the uteroservical length measured in the ultrasound.
Main outcome variables
Chemical pregnancy, clinical pregnancy, early abortion, implantation rate
General information
Reason for update
Update methodology changes
Acronym
IRCT registration information
IRCT registration number:IRCT20110509006420N24
Registration date:2021-12-08, 1400/09/17
Registration timing:registered_while_recruiting
Last update:2022-08-04, 1401/05/13
Update count:2
Registration date
2021-12-08, 1400/09/17
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
2021-12-06, 1400/09/15
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of fetal transfer results under abdominal ultrasound with fetal transfer based on previous measurement of uterine length with vaginal ultrasound in assisted reproductive cycles
Public title
fetal transfer under abdominal ultrasound compared with fetal transfer based on the previous measurement of uterine length
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women who are candidates for frozen embryo transfer.
Exclusion criteria:
Severe male infertility includes cases of azoospermia and sperm from TESE or PESA
History of uterine surgery such as hysteroscopic surgery
Body mass index more than 30
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
Each participant is assigned a number from 1 to 260, and then 9 blocks of 32 are considered, and then each block is randomly selected. In each block, the type of treatment protocol of the participants is determined. Randomization using software The random allocation 1 software will be a block randomization method. The randomization of samples in each block is independent, which is specified by the software, and the researchers do not know about the randomized list.
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 Research and Clinical Center for infertility, Shahid Sadoughi University
Street address
Bouali Ave, Safaeiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.SSU.RSI.REC.1399.047
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
15 days after embryo transfer
Method of measurement
Blood laboratory kit
2
Description
Clinical pregnancy
Timepoint
3 weeks after positive beta-h Cg
Method of measurement
Observation of fetal heart activity by transvaginal ultrasonography
Secondary outcomes
1
Description
Early Miscarriage rate
Timepoint
10 weeks after embryo transfer
Method of measurement
Absence of fetal heart activity in ultra sound sonography
2
Description
Implantation rate
Timepoint
3 weeks after positive beta-h Cg
Method of measurement
Calculated by the number of gestational sacs observed on ultrasound on the number of embryos transferred
Intervention groups
1
Description
Intervention group: intervention group receives 6 mg of oral estradiol from the second day of the cycle, and on the 13th cycle, transvaginal ultrasound is performed. Embryo transfer takes place in the 8-cell cleavage stage. Ultrasound measurement of uterine length is performed before transfer with vaginal ultrasound and the length of the catheter is adjusted based on the uterocervical length measured in the ultrasound.
Category
Treatment - Other
2
Description
Intervention group: receives 6 mg of oral estradiol daily from the second day of the cycle and on day 13 of the cycle, transvaginal ultrasound is performed. Embryo transfer takes place at the stage of 8-cell cleavage. Transfer is performed under the guidance of abdominal ultrasound.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Freshteh Bahrami
Street address
Safaeiyeh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 3824 7085
Email
freshtehbahrami1966@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hooshang Mehrparvar
Street address
bahonar Ave
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
ah.mehrparvar@gmail.com
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
Safaeiyeh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 1824 7085
Email
eftekharmaryam@yahoo.com
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
Safaeiyeh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
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
Safaeiyeh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 1824 7085
Email
eftekharmaryam@yahoo.com
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
A journal in which the results are published
Under which criteria data/document could be used
Submission of an official application via the agent that is legally in charge
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.