Should the site of embryo transfer be changed according to endometrial cavity length?

ISRCTN ISRCTN15972342
DOI https://doi.org/10.1186/ISRCTN15972342
Secondary identifying numbers N/A
Submission date
11/02/2015
Registration date
27/02/2015
Last edited
29/07/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr hwang kwon
Scientific

CHA Fertility Center of Bundang
CHA General Hospital
351 Yatap-dong
Bundang-gu
Seongnam
463-712
Korea, South

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleShould the site of embryo transfer be changed according to endometrial cavity length: a prospective randomized controlled trial
Study objectivesThere 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(s)Institutional Review Board of Bundang CHA Hospital, 04/07/2012, ref: BD2012-095D
.
Health condition(s) or problem(s) studiedPregnancy
InterventionGroup A: embryo transfer catheter tip positioned at 2 cm DFE
Group B: embryo transfer catheter tip positioned at midpoint area of ECL
Intervention typeProcedure/Surgery
Primary outcome measurePregnancy outcomes such as implantation rates, chemical pregnancy rates, clinical pregnancy rates, ongoing pregnancy rates.
Secondary outcome measuresEctopic pregnancy and miscarriage rates.
Overall study start date01/06/2012
Completion date31/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants100 in each group compared. 200 women in total.
Key inclusion criteriaAll women who undergo controlled ovarian stimulation.
Key exclusion criteria1. 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.
Date of first enrolment01/06/2012
Date of final enrolment18/12/2014

Locations

Countries of recruitment

  • Korea, South

Study 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

Bundang CHA General Hospital
Hospital/treatment centre

Funders

Funder type

Hospital/treatment centre

Bundang CHA General Hospital

No information available

Results and Publications

Intention to publish date30/08/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 29/07/2015 Yes No