Evaluation of the effect of sequential embryo transfer on pregnancy outcome in repeated implantation failure (RIF) patients
Design
The study was designed as two armed randomized clinical trial with 100 patients in each group of patients with RIF. Stratified block will perform using site: https://www.sealedenvelope.com based on age and number of failures.
Settings and conduct
The trial will be performed in two infertility treatment center ( Avicenna fertility clinic and Bahman hospital). Volunteer patients will be enrolled to the study after evaluation of inclusion and exclusion criteria. After ovarian stimulation , follicles size will be determined in 9th days of mensturation cycle using ultrasound, then HCG will be injected and the ovarian puncture procedure will be implemented. Then patients will be randomly allocated in two groups with Stratified Block Randomization method using www.sealedenvelope.com site as Intervention group (Sequential Embryo transfer) and Control Group (one step embryo transfer).
This trial is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria :
History of at least 2 implantation failure in assisted reproduction techniques ,
Age<40,Normal karyotype,Normal Endometrium,at least 3 good quality embryo in embryology laboratory,
Exclusion Criteria :
Hetero-zygote thrombophilia at least in 2 gene,Hydrosalpinx, severe male factor infertility
Intervention groups
Intervention group: Sequential embryo transfer will be done in days 3 and then 5 after fertilization
Control group: Common embryo transfer will be done in day 5 after fertilization
Main outcome variables
Clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200421047152N1
Registration date:2020-06-28, 1399/04/08
Registration timing:registered_while_recruiting
Last update:2020-06-28, 1399/04/08
Update count:0
Registration date
2020-06-28, 1399/04/08
Registrant information
Name
Arash Mohazzab
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2351 9630
Email address
amohazzab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of sequential day3/ day5 embryo transfer on Improvement of pregnancy rate in patients with repeated implantation failure
Public title
Sequential embryo transfer trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with history of implantation failure more than two times
Age<40
At least 3 good quality embryo formation in embryology lab
Normal endometrium
Normal karyo-type
Exclusion criteria:
Hetero zygote thrombophilia panel > 2
Hydrop-salpinx
Severe male factor Infertility
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:
200
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be Stratified block randomization based on age and number of previous treatment failure.
Patients will be categorized into quadri-cell blocks based on age ( higher and lower than 30) and also number of previously failed treatment (higher and lower than 5) , then they will be allocated randomly in two groups of the trial using the https://www.sealedenvelope.com site's software.
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
Ethical commitee of Avicenna Reserch Institute,ACECR affiliated research institute in biotechnology
Street address
Daneshjou Blvrd. Evin. Chamran Exp.way
City
Tehran
Province
Tehran
Postal code
1985743413
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1399.001
Health conditions studied
1
Description of health condition studied
Recurrent implantation failure
ICD-10 code
N98.2
ICD-10 code description
Complications of attempted introduction of fertilized ovum following in vitro fertilization
Primary outcomes
1
Description
Clinical Pregnancy
Timepoint
3rd- 4th week after embryo transfer
Method of measurement
Trans-vaginal ultrasound
Secondary outcomes
1
Description
Chemical Pregnancy
Timepoint
two or three weeks after Embryo transfer
Method of measurement
Serum Beta HCG
Intervention groups
1
Description
Intervention group: Embryo transfer will be done in two steps in this group.A good quality morola phase embryo will be transfered in 3rd day after fertilization. In the next step a good quality blastocyst phase embryo will be transfered in the 5th day
Category
Treatment - Surgery
2
Description
Control group: Two good quality blastocyst phase embryos will be transfered in day 5th after fertilization
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna Fertility Clinic
Full name of responsible person
Soheila Arefi
Street address
Yakhchal Junction , Shariati street
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
soheilaarefi@yahoo.com
2
Recruitment center
Name of recruitment center
Bahman Hospital
Full name of responsible person
Sohelia Arefi
Street address
North Iran Zamin Street , Shahrak-Gharb
City
Tehran
Province
Tehran
Postal code
1465795481
Phone
+98 21 8857 5901
Email
soheilaarefi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Mohammad Reza Sadeghi
Street address
Daneshjou Blvrd, Evin
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Email
Sadeghi@avicenna.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Research Institute
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
Iranian academic center for education culture and research
Full name of responsible person
Professor Soheila Arefi
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Inferility
Street address
Yakhchal Junction , Shariati
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
soheilaarefi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Professor Soheila Arefi
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Inferility
Street address
Yakhchal Junction , Shariati
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
soheilaarefi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Arash Mohazzab
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Epidemiology
Street address
Yakhchal Junction, Shariati street
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 2351 9630
Fax
Email
amohazzab@yahoo.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Informed consent in which was approved by ethical committee will be available for medical researchers.
When the data will become available and for how long
After patients recruitment
To whom data/document is available
medical researchers
Under which criteria data/document could be used
Trial design
From where data/document is obtainable
Professor Soheila Arefi
Dr. Arash Mohazzab
What processes are involved for a request to access data/document