Condition category
Pregnancy and Childbirth
Date applied
11/02/2015
Date assigned
27/02/2015
Last edited
29/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr hwang kwon

ORCID ID

Contact details

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

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

Publication citations

Additional files

Editorial Notes