Comparison of the effect of tow embryo transfer in the stage of blastocyst and sequential transfer of a cleavage-a blastocyst embryo on pregnancy outcomes Patients who are candidates for frozen embryo transfer and recurrent implantation failure; a randomized clinical trial
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General information
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140
140
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2024-02-04, 1402/11/15
2024-02-04 00:00:00
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2024-08-05, 1403/05/15
2024-08-05 00:00:00
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2024-09-14, 1403/06/24
2024-09-14 00:00:00
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End of patient admission and end of clinical trial
End of patient admission and end of clinical trial
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پایان بیمارگیری وپایان کارازمایی بالینی
پایان بیمارگیری وپایان کارازمایی بالینی
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: nooshin hatamizadeh
Full name of responsible person - Persian: نوشین حاتمی زاده
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: Nooshin Hatamizadeh
Full name of responsible person - Persian: نوشین حاتمی زاده
Street address - English: Yazd Reproductive Sciences Institute, BouAl Ave., Safaeih, Yazd
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: 8916877391
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: nooshin hatamizadehNooshin Hatamizadeh Full name of responsible person - Persian: نوشین حاتمی زاده Street address - English: Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، YazdAve., Safaeih, Yazd Province Street address - Persian: یزد ، صفائیه ، خیابان بوعلی ، پژوهشکده علوم تولید مثل یزد City - English: yazdYazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: ۸۹۱۶۸۷۷۳۹۱8916877391 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:
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: yazdYazd 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 the effect of transferring two embryos in the blastocyst stage and sequential transfer of one cleaved blastocyst embryo on pregnancy outcomes in patients who are candidates for frozen embryo transfer and have a history of repeated implantation failure.
Design
The phase 3 clinical trial, with a control group, will be conducted in parallel on 140 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 criteria for entering the study are divided into two groups: blastocyst and sequential transfer.
Participants/Inclusion and exclusion criteria
Women under 45 years of age with frozen embryos and a history of 2 implantation failures
Intervention groups
Eligible people who have at least 4 frozen embryos are randomly placed in two consecutive transfer groups of one cleavage embryo and one blastocyst embryo and two blast embryos. In the blastocyst group 5 days after the start of progesterone and in the consecutive group once 3 days after the start Progesterone and once 5 days after the start of progesterone, embryo transfer takes place
Main outcome variables
Clinical pregnancy
General information
Reason for update
End of patient admission and end of clinical trial
Acronym
IRCT registration information
IRCT registration number:IRCT20110509006420N27
Registration date:2024-01-27, 1402/11/07
Registration timing:prospective
Last update:2024-12-13, 1403/09/23
Update count:2
Registration date
2024-01-27, 1402/11/07
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
2024-02-04, 1402/11/15
Actual recruitment end date
2024-08-05, 1403/05/15
Trial completion date
2024-09-14, 1403/06/24
Scientific title
Comparison of the effect of tow embryo transfer in the stage of blastocyst and sequential transfer of a cleavage-a blastocyst embryo on pregnancy outcomes Patients who are candidates for frozen embryo transfer and recurrent implantation failure; a randomized clinical trial
Public title
Comparison of the effect of tow embryo transfer in the stage of blastocyst and sequential transfer of a cleavage-a blastocyst embryo on pregnancy outcomes Patients who are candidates for frozen embryo transfer and recurrent implantation failure; a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for frozen embryo transfer
Failure of more than 2 implants
The number of frozen embryos is at least four
Women under the age of 45
Exclusion criteria:
Uncontrolled endocrine diseases (diabetes, hyperthyroid and hypothyroid)
Egg donation
Uncontrolled autoimmune diseases (lupus and rheumatoid arthritis)
Severe uterine adenomyosis
Sever Asherman
Untreated hydrosalpinx
Age
To 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
Actual sample size reached:
140
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. Then a random list will be generated based on the number of samples in each group
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
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2024-01-10, 1402/10/20
Ethics committee reference number
IR.SSU.RSI.REC.1402.020
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
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Through the measurement of BHCG
2
Description
Twin pregnancy
Timepoint
In the 6th week of pregnancy
Method of measurement
Observation of two gestational sacs in vaginal ultrasound
3
Description
The rate of premature abortion
Timepoint
Ten weeks after embryo transfer
Method of measurement
Absence of fetal heartbeat in sonography
4
Description
Ectopic pregnancy
Timepoint
After proving chemical pregnancy
Method of measurement
Not increasing beta hCG titer and not seeing pregnancy sac in vaginal ultrasound
Intervention groups
1
Description
Intervention group: Infertile people who are candidates for frozen embryo transfer with a history of two implantation failures, if their number of embryos is at least 4, after obtaining a written consent, embryo transfer will be done for them consecutively. In this way, in the first stage, an embryo is cleaved and two to three days after the transfer of the first embryo, the transfer of the second embryo is done in the form of a blast.
Category
Treatment - Other
2
Description
Control group: Infertile candidates for frozen embryo transfer with a history of twice implantation failure, if their number of embryos is at least 4, after obtaining a written consent, they will undergo embryo transfer in one step. In this way, two blastocyst embryos will be transferred to them at the same time.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Institute
Full name of responsible person
Nooshin Hatamizadeh
Street address
Yazd Reproductive Sciences Institute, BouAl Ave., Safaeih, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
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
City
Yazd
Province
Yazd
Postal code
8916877391
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
City
Yazd
Province
Yazd
Postal code
8916877391
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
City
Yazd
Province
Yazd
Postal code
8916877391
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.