3D/4D ultrasound guided embryo transfer vs clinical touch technique

Plain English Summary

Background and study aims
In vitro fertilisation (IVF) is a technique that is used to help people with fertility problems to have a baby. During IVF, an egg is taken from the woman's ovaries and fertilised with sperm in a laboratory. The fertilised egg (embryo) is then returned to the woman's uterus (womb). Current embryo transfer techniques have remained largely unchanged since IVF treatment began. Traditionally there have been two techniques: a “clinical touch” method used to guide the transfer catheter (tube) to within 10mm of the uterine fundus (top of the uterus) before injection of the embryo. This is essentially a “blind” procedure and works on tactile sensation (touch). Similarly some clinicians transfer the embryos at a fixed distance from the external cervical opening (about 6cm), but this works on the assumption that the uterine dimensions including the cervix are the same for all women. If the catheter damages the endometrium (the lining of the uterus) or touches the fundus, this causes uterine contractions which lead to lower embryo implantation rates. The use of ultrasound during embryo transfer was first discussed in 1995 to allow accurate positioning of the catheter tip near the uterine fundus and hence improve pregnancy rates. The technique has often been described as “cleaner” with the ability to tailor the placement of the embryo to the individual. Ultrasound guided embryo transfer is recommended by NICE and is used in 77% of embryo transfers worldwide. Traditionally, ultrasound guided embryo transfer has been performed using trans-abdominal 2D ultrasound. More recently, ultrasound technology and capabilities have advanced so that 3D and 4D imaging of the uterus can now be achieved, showing finer detail with greater clarity, as well as enabling spatial awareness in terms of the dimensions and volume of the uterus. It is reasonable to assume that more accurate placement of the transfer catheter and the embryo(s) could result in higher pregnancy rates. In a small study, transabdominal 3D ultrasound was used to confirm the correct placement of a trial catheter before embryo transfer, which was not subsequently performed under ultrasound guidance. A second study also confirmed the ability to ensure correct catheter placement using 3D and 4D ultrasound using transabdominal ultrasound, and reported an increase in pregnancy rate from 36.66% to 65%. With the availability of the Kitazato embryo transfer catheter, the ability to perform an embryo transfer using a transvaginal 3D/4D ultrasound scan has become possible. The resolution of images obtained using transvaginal ultrasound appears superior to similar images obtained through transabdominal scanning. The aim of this study is to find out whether this technique results in better pregnancy rates and outcomes.

Who can participate?
Women undergoing fresh or frozen embryo transfer

What does the study involve?
Participants are randomly allocated into either the intervention group or the control group. In the intervention group, a transvaginal ultrasound is performed to guide the embryo transfer. In the control group the embryo placement is carried out using the clinical touch technique. All participants are followed up for 10 months to record the number of live births.

What are the possible benefits and risks of participating?
Benefits may include an improved pregnancy rate. Ultrasound guidance may also reduce the number of failed embryo transfers due to better catheter placement. Risks between the groups should be similar. Ectopic pregnancy rates should be similar between groups and there is likely still to be a miscarriage risk. Intervention group transfers may take slightly longer than control group transfers. Discomfort is likely to be similar in both groups.

Where is the study run from?
Liverpool Women's NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
February 2018 to September 2020

Who is funding the study?
Liverpool Women's NHS Foundation Trust (UK)

Who is the main contact?
1. Dr Lewis Nancarrow (public)
2. Mr Richard Russell (scientific)
3. Miss Louise Hardman (public)

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Liverpool Women’s NHS Foundation Trust
Hospital/treatment centre

Crown Street
Liverpool
L8 7SS
England
United Kingdom

"ROR"	https://ror.org/04q5r0746

Funders

Funder type

Hospital/treatment centre

Results and Publications

Study outputs

Additional files

ISRCTN79955797_PROTOCOL_V3_21Mar16.docx

Uploaded 02/04/2019

Editorial Notes

06/03/2024: Publication reference added.
20/01/2022: Publication references added.
19/10/2020: The intention to publish date was changed from 30/11/2020 to 01/02/2021.
17/02/2020: The IRAS number has been added.
12/02/2020: The total final enrolment number has been added
The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2019 to 30/01/2020.
2. The overall end date was changed from 01/06/2020 to 30/09/2020.
3. The intention to publish date was changed from 01/10/2020 to 30/11/2020.
4. The plain English summary was updated to reflect these changes.
02/04/2019: Uploaded protocol (not peer reviewed).
20/07/2018: The following changes have been made to the trial record:
1. The trial end date has been changed from 01/06/2019 to 01/06/2020
2. The recruitment end date has been changed from 01/06/2018 to 01/06/2019
3. The intention to publish date has been changed from 01/01/2021 to 01/10/2020