Should the site of embryo transfer be changed according to endometrial cavity length?
| ISRCTN | ISRCTN15972342 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15972342 |
| Protocol serial number | N/A |
| Sponsor | Bundang CHA General Hospital |
| Funder | Bundang CHA General Hospital |
- 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
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
Scientific
CHA Fertility Center of Bundang
CHA General Hospital
351 Yatap-dong
Bundang-gu
Seongnam
463-712
Korea, South
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Should the site of embryo transfer be changed according to endometrial cavity length: a prospective randomized controlled trial |
| Study objectives | 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(s) | Institutional Review Board of Bundang CHA Hospital, 04/07/2012, ref: BD2012-095D . |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Pregnancy outcomes such as implantation rates, chemical pregnancy rates, clinical pregnancy rates, ongoing pregnancy rates. |
| Key secondary outcome measure(s) |
Ectopic pregnancy and miscarriage rates. |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 200 |
| Key inclusion criteria | All women who undergo controlled ovarian stimulation. |
| Key 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. |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 18/12/2014 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Bundang-gu
Seongnam
Gyeonggi-do
Seongnam
463-712
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/07/2015 | Yes | No |
