Plain English Summary
Background and study aims
There is a lot of debates about the best area in the endometrial cavity in which to transfer embryos. The aim of the study is to compare two areas and assess the impact on implantation and pregnancy rates.
Who can participate?
Female adults going for embryo transfers at the CHA Fertility Center of Bundang CHA General Hospital
What does the study involve?
Participants are randomly allocated to one of two groups: group A = embryo transfer 2cm from fundal endometrium (DFE) or group B = at the midpoint of the endometrial cavity length (ECL)
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
CHA Fertility Center of Bundang CHA General Hospital (South Korea)
When is the study starting and how long is it expected to run for?
From July 2012 to December 2014.
Who is funding the study?
CHA Fertility Center of Bundang CHA General Hospital (South Korea)
Who is the main contact?
hwangkwon98@gmail.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Should the site of embryo transfer be changed according to endometrial cavity length: a prospective randomized controlled trial
Acronym
Study hypothesis
There is a difference in implantation rates and pregnancy rates when the site of the embryo transfer is positioned 2 cms from the fundal endometrium (DFE) or at the midpoint of the endometrial cavity length (ECL).
Ethics approval
Institutional Review Board of Bundang CHA Hospital, 04/07/2012, ref: BD2012-095D
.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pregnancy
Intervention
Group A: embryo transfer catheter tip positioned at 2 cm DFE
Group B: embryo transfer catheter tip positioned at midpoint area of ECL
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Pregnancy outcomes such as implantation rates, chemical pregnancy rates, clinical pregnancy rates, ongoing pregnancy rates.
Secondary outcome measures
Ectopic pregnancy and miscarriage rates.
Overall trial start date
01/06/2012
Overall trial end date
31/12/2014
Reason abandoned
Eligibility
Participant inclusion criteria
All women who undergo controlled ovarian stimulation.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100 in each group compared. 200 women in total.
Participant exclusion criteria
1. When embryos are expected to be frozen due to ovarian hyperstimulation.
2. When embryo transfer is not performed by same physician because of absence of physician.
Recruitment start date
01/06/2012
Recruitment end date
18/12/2014
Locations
Countries of recruitment
Korea, South
Trial participating centre
CHA Fertility Center of Bundang CHA General Hospital
351 Yatap-dong
Bundang-gu
Seongnam
Gyeonggi-do
Seongnam
463-712
Korea, South
Sponsor information
Organisation
Bundang CHA General Hospital
Sponsor details
351 Yatap-dong
Bundang-gu
Seongnam
463-712
Korea
South
Sponsor type
Hospital/treatment centre
Website
http://bundang.chamc.co.kr/MedicalInfo/ClinicalTestBoardView.aspx?menucode=1528&no_index=136
Funders
Funder type
Hospital/treatment centre
Funder name
Bundang CHA General Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
30/08/2015
Participant level data
Available on request
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26216410