Comparison of Pregnancy Rate in Mixed double embryo transfer (MDET) with Transfer single blastocyst Embryo transfer (SBET) in Recurrent Implantation Failure (RIF)
Comparison of Pregnancy Rate in Mixed double embryo transfer (MDET) with Transfer single blastocyst Embryo transfer (SBET) in Recurrent Implantation Failure (RIF)
Design
the controlled clinical trial, with parallel groups, two-way blind, randomized, on 126 patients. Computer random assignment list produced with PASS software.
Settings and conduct
This is a double-blind randomized clinical trial. Couples with a history of Recurrent Implantation Failure (RIF) who have been referred to Milad Infertility Center during 1300-1400 and meet the inclusion criteria are included in the study. The number of samples is about 56 people in each group. Intervention group: On the day of transfer, one cleavage-stage embryo that thawed the same day and one Blast stage embryo that thawed 2 days before and reached the blast stage are transferred and in control groups, two Blast embryos are transferred
Participants/Inclusion and exclusion criteria
Infertile women (18-42 years) with a history of at least two failed embryo transfers and at least two good-quality embryos have been transferred.• There are at least two 3-day-old freezers with grade 1 or 2• Normal couple karyotype• Lack of uterine abnormalities and thrombophilic disorders
Intervention groups
Intervention group: On the day of transfer, one cleavage-stage embryo that thawed the same day and one Blast stage embryo that thawed 2 days before and reached the blast stage are transferred
Main outcome variables
Pregnancy confirmed by positive BHCG test two weeks after embryo transfer) and clinical (pregnancy confirmed by transvaginal ultrasound 6 weeks. Ongoing prgnancy : Continued pregnancy up to 20 weeks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181030041503N5
Registration date:2021-12-11, 1400/09/20
Registration timing:registered_while_recruiting
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Malihe Mahmoudinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9878
Email address
mahmoudiniam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Pregnancy Rate in Mixed double embryo transfer (MDET) with Transfer single blastocyst Embryo transfer (SBET) in Recurrent Implantation Failure (RIF)
Public title
Comparison of pregnancy rates in simultaneous 3 and 5-day embryo transfer with 5-day embryo transfer in patients with a history of recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women (18-42 years) with a history of at least two failed embryo transfers and at least two good-quality embryos have been transferred.• There are at least two 3-day-old freezers with grade 1 or 2• Normal couple karyotype• Lack of uterine abnormalities and thrombophilic disorders
Exclusion criteria:
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
-In this randomized clinical trial 126 patients, two groups were randomly assigned.
-Method used to generate random allocation sequence by mentioning the name of the software or site used: Computer random assignment list produced with PASS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this randomized clinical trial 126 patients, two groups were randomly assigned.
-Method used to generate random allocation sequence by mentioning the name of the software or site used: Computer random assignment list produced with PASS software.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of medical sciences Ethics committee
Street address
Vice chancellor of Research, Mashhad university of Medical Sciences, Mashhad University of Medical Sciences ,University Avenue.Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.126
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfer
Primary outcomes
1
Description
chemical pregnancy rate
Timepoint
2 week after embryo transfer
Method of measurement
BHCG serum
2
Description
The rate of clinical pregnancy
Timepoint
6 weeks after embryo transfer
Method of measurement
Sonography
3
Description
ongoing pregnancy
Timepoint
Continue pregnancy for up to 12 weeks
Method of measurement
Transvaginal ultrasound
Secondary outcomes
1
Description
Rate of miscarriage
Timepoint
Before 20 weeks of pregnancy
Method of measurement
Bleeding and expulsion of the fetus
Intervention groups
1
Description
Intervention group: On the day of transfer, one cleavage-stage embryo that thawed the same day and one Blast stage embryo that thawed 2 days before and reached the blast stage are transferred
Category
Treatment - Other
2
Description
Control group: Two Blast embryos are transferred
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility center
Full name of responsible person
Malihe Mahmoudinia
Street address
Milad Infertility center, Mashhad, Khorasan Razaviخراسان رضوی، مشهد، مرکز نازایی میلاد
City
mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
mahmoudiniam@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen, Tafaghodi
Street address
Vice Chancellor of Research, Mashhad university of Medical sciences, university Avenue Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maliheh Mahmoudinia
Position
استاديار
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mashhad,Daneshghahstreet,Imam.Reza Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3853 4021
Email
mahmoudiniam@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Mahmoudinia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mashhad,Daneshgah Avenue,Imam Reza Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3802 2608
Email
mahmoudiniam@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
malihe Mahmoudinia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mashhad,Daneshgah Avenue ,Imam Reza Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3802 2608
Email
mahmoudiniam@mums.ac.ir
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
Not applicable
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