The pregnancy outcome of sequential embryo transfer compared to blastocyst embryo transfer on patients with repeated implantation failure in frozen and thawed embryo transfer cycles-randomized clinical trial
Pregnancy outcomes of sequential embryo transfer will be compared with blastocyst transfer in patients with recurrent implantation failure.
Design
An controlled, randomized clinical trial with a parallel-group design of 200 patients, enrolled between 2021 and 2023.
Settings and conduct
The present study will be performed at Mehr Medical Institute. In the control group, 1 to 3 blastocysts will be transferred into the uterus on day 5 or 6. In the intervention group, two top or good quality embryos will be transferred on day 2 or 3 and then one blastocyst will be transferred on day 5.
Participants/Inclusion and exclusion criteria
Participants
Patients with recurrent implantation failure
Inclusion criteria
Age less than 40 years
History of two or more implantation failure cycles
Presence of 3 top and good quality embryos
Exclusion criteria
Recent uterine pathologies that disrupt the pregnancy process
Preimplantation genetic diagnosis cycles
Lack of embryo growth to the blastocyst stage
Intervention groups
intervention group- Transfer of 2 top and good quality embryos on the second or third day and transfer of 1 blastocyst on the fifth day
Control group- Transfer of 1 to 3 blastocysts into the uterus on day 5 or 6
The pregnancy outcome of sequential embryo transfer compared to blastocyst embryo transfer on patients with repeated implantation failure in frozen and thawed embryo transfer cycles-randomized clinical trial
Public title
Sequential embryo transfer in repeated implantation failure
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 40 years
History of two or more repeated implantation failure cycles
Presence of 3 top and good quality embryos
Exclusion criteria:
Recent uterine pathologies that disrupt the pregnancy process
Preimplantation genetic diagnosis cycles
Lack of embryo development until the blastocyst stage
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using computer software. The list of blocks will be written and numbers will be assigned to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)), then random numbers between one and six ( For example, 1 4 5, etc.) will be select and finally the treatment allocation list based on previous random numbers (AABB, BBAA, BABA, etc.) will be specified.
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
Research Ethics Committee of Guilan university of medical sciences
Street address
Shahid Siadati Ave, Namjoo St, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
6694941446
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
IR.GUMS.REC.1400.375
Health conditions studied
1
Description of health condition studied
Repeated implantation failure
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Biochemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Blood test
2
Description
Clinical pregnancy
Timepoint
Six weeks after embryo transfer
Method of measurement
Ultrasound
3
Description
Implantation
Timepoint
Six weeks after embryo transfer
Method of measurement
Ultrasound
4
Description
Multiple pregnancy
Timepoint
During pregnancy
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Ongoing pregnancy
Timepoint
Twelve weeks following embryo transfer
Method of measurement
Ultrasound
2
Description
Early pregnancy loss
Timepoint
Twelfth week of pregnancy
Method of measurement
Ultrasound
3
Description
Late miscarriage
Timepoint
Twelfth to twenty-eighth week
Method of measurement
Ultrasound
Intervention groups
1
Description
Intervention group: In consecutive embryo transfer, first; 2 embryos of top and good quality will be transferred on day 2 or 3. The embryos will then be cultured to the blastocyst stage and 1 blastocyst will be transferred on day 5 or 6.
Category
Treatment - Other
2
Description
Control group: One to three blastocysts will be transferred on day 5 or 6.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr medical institute
Full name of responsible person
Marzieh Mehrafza
Street address
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
marzieh.mehrafza@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mehr medical institute
Full name of responsible person
Marzieh Mehrafza
Street address
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
marzieh.mehrafza@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mehr medical institute
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Position
CEO of Mehr medical institute
Latest degree
Subspecialist
Other areas of specialty/work
Reproductive Biology
Street address
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
marzieh.mehrafza@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Position
CEO of Mehr medical institute
Latest degree
Subspecialist
Other areas of specialty/work
Reproductive Biology
Street address
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
marzieh.mehrafza@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mehr medical institute
Full name of responsible person
Marzieh Mehrafza
Position
CEO of Mehr medical institute
Latest degree
Subspecialist
Other areas of specialty/work
Reproductive Biology
Street address
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
marzieh.mehrafza@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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