Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In vitro fertilisation (IVF) is a technique used to help people with fertility problems to have a baby. Before undergoing IVF, the shape of the woman’s uterine cavity (the space inside the uterus) must be checked for abnormalities. The detection and treatment of uterine cavity abnormalities can increase the success rate of IVF treatment. A 2-D transvaginal ultrasound scan (2-D TVS) is a simple tool for finding uterine cavity abnormalities. It involves scanning with an ultrasound probe placed inside the vagina. Saline infusion sonography (SIS) is a test where a small volume of saline (salt solution) is inserted into the uterus to allow the lining of the uterus to be clearly seen on an ultrasound scan. We can obtain more information about the uterine cavity from SIS. The aim of this study is to find out whether performing a SIS before starting an IVF cycle improves the likelihood of achieving a live birth, compared with the use of 2-D TVS.

Who can participate?
Women under the age of 40 and undergoing their first or second IVF treatment cycle.

What does the study involve?
All participants undergo a 2-D TVS. If the initial scan is normal, the participants are then randomly allocated to undergo either SIS or another 2-D TVS before commencing their IVF treatment. After 12 months the number of live births in both groups is recorded.

What are the possible benefits and risks of participating?
Using SIS may increase the chances of finding and treating uterine cavity abnormalities. There is a minimal risk of infection and pain with SIS. However, this risk is minimised with infection screening and taking analgesia (painkillers) before the procedure.

Where is the study run from?
The Assisted Conception Unit at Guy’s Hospital (UK)

When is the study starting and how long is it expected to run for?
June 2012 to June 2015

Who is funding the study?
The Assisted Conception Unit at Guy’s Hospital (UK)

Who is the main contact?
Mr Yacoub Khalaf

Trial website

Contact information



Primary contact

Mr Yacoub Khalaf


Contact details

Assisted Conception Unit
Tower Wing
Guy’'s Hospital
Great Maze Pond
United Kingdom
+44 (0)20 7188 0501

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial comparing Transvaginal Ultrasonography versus Saline sonography Trial in patients having their IVF treatment - TRUST-IVF study



Study hypothesis

The pregnancy rate in the SIS group is no different to pregnancy rate in the 2-D transvaginal ultrasound scan (2-D TVS) control group. The alternative hypothesis is that pregnancy rate in the Saline sonography (SIS) group is equal to or higher than pregnancy rate in the control group.

The evaluation of the shape and regularity of the uterine cavity is one of the basic steps in the workup of infertile couples before in vitro fertilisation (IVF). Uterine cavity abnormalities have been reported to be more prevalent in subfertile women and are estimated to be the etiologic factor in as many as 10-–15% of couples seeking treatment.The detection and treatment of these intrauterine pathologies can potentially increase the success rates of IVF treatment.

Ethics approval

NRES committee London- Riverside ; South west Research Ethics Committee, Bristol, 17/01/2012, ref: 11/LO/1591

Study design

Prospective randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


In vitro fertilisation (IVF)


All women recruited for the trial will undergo a 2-D TVS. If the initial scan is normal, the participants will then undergo randomisation to receive SIS or another 2-D TVS before commencing their treatment.

Saline infusion sonography arm : A SIS is a well-tolerated internal examination that uses a fine catheter, which is passed through the cervix by initially performing a speculum examination. A small amount of saline (5-10 ml) is passed through the catheter and a transvaginal scan is performed at the same time to examine the lining and shape of the womb cavity. The procedure usually takes approximately 10 minutes to complete. After the scan, if there are any abnormalities identified, the patient will be listed for surgery to have the abnormality removed.

Transvaginal scan: A transvaginal scan is an internal scan which is routinely performed as a part of the infertility investigations. The patient will be asked to empty their bladder and lie down on a couch with the legs on stirrups. A doctor or nurse will perform the transvaginal scan.They will be taking measurements of the uterus and ovaries and any other additional pathology. This procedure should take no longer than 10 minutes.

The follow up for all the treatment arms is 12 months.

Intervention type



Drug names

Primary outcome measures

Livebirth rate

Secondary outcome measures

1. Clinical pregnancy rate
2. Implantation rate
3. Uterine anomaly rate

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Women undergoing their first and second IVF/ ICSI (Intra Cytoplasmic Sperm Injection) treatment
2. Women under the age of 40 and undergoing their first or second IVF cycle will be eligible to participate in the trial

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Women aged more than 40 years (women aged 41 years or more).
2. Known submucous fibroids, polyps, intrauterine adhesions or uterine surgery
3. Untreated Hydrosalpinges (women whose hydrosalpinges have been treated with clipping, salpingectomy or ligation will be included)
4. Recurrent implantation failure defined as patients undergoing three or more IVF cycles

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Guy’'s Hospital
United Kingdom

Sponsor information


Guy's Hospital (UK)

Sponsor details

Assisted Conception Unit
Tower Wing
Great Maze Pond
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Guy's Hospital - Assisted Conception Unit (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/01/2016: Plain English summary added