Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Saline infusion sonohysterography is an accurate ultrasound procedure that allows health care professionals to look at the inside of the uterus (endometrial cavity) and the uterus lining (endometrium). They are used for a number of reasons, including looking for polyps, investigating the reasons for postmenopausal (after the menopause) bleeding and looking at the shape of the endometrial cavity (this can be useful in investigating problems such as multiple miscarriages or infertility). It is a simple procedure often done in outpatient clinics, but it can be uncomfortable due to leaking of the saline during the test. Gel is now often used instead, as it is thought that using a gel (gel infusion sonohysterography) is less painful than saline and that it produces clearer images and allows for 3D sonography (for example, 3D ultrasound). A number of gels are available, some containing pure hydroxyethyl glycerin, others containing small amount of chlorhexidine with or without lidocaine. This may be important, as different gels may affect how painful the procedure is, cause different side effects and affect the quality of the image made, but there is, as yet, no published data on this. We suggest that a sonohysterography using gel that contains small amounts of chlorhexidine will be more painful than if a gel containing pure hydroxyethyl glycerine is used, but the resulting images produced will be of equal quality. The main purpose of this study is to compare two types of gel, Endosgel (which contains chlorhexidine) and ExEmgel (containing hydroxyethylcellulose and glycerol)

Who can participate?
Women aged between 20-80 years, suffering from either abnormal bleeding from the uterus or infertility believed to be due to an abnormality of the uterus and planned for a gel infusion sonohysterography (GIS).

What does the study involve?
Patients are randomly allocated into one of two groups. One group has GIS using Endosgel and the other group ExEmgel. Patients report on any pain felt during the procedure and the quality of the images obtained compared. Patients are then called by telephone to talk again about any pain experienced 3 weeks and then 3 months after the GIS

What are the possible benefits and risks of participating?
Both gels are used routinely and, in general, are well-tolerated and safe. Some discomfort may be felt by patients during the procedure.

Where is the study run from?
The VU University Medical Center (Netherlands)

When is the study starting and how long is it expected to run for?
September 2012 to March 2014

Who is funding the study?
1. Dutch Ministry of Education, Culture and Science (Netherlands)
2. VU University Medical Center (Netherlands)

Who is the main contact?
Dr Judith Huirne

Trial website

Contact information



Primary contact

Dr Judith Huirne


Contact details

Boelelaan 1117
+31 (0) 204444444

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Gel instillation sonohysterography (GIS) using Endosgel versus ExEmgel, comparison of pain and image quality


GISPAIN (Gel Insillation Sonography and PAIN scores)

Study hypothesis

The purpose of this study is to compare two types of gel, Endosgel and ExEmgel, during gel instillation sonohysterography with respect to patients pain perception and image quality. We hypothesize that gel including small amounts of chlorhexidine induces more pain compared to pure hydroxethyl glycerin gel.

Ethics approval

Medical Ethical Review Committee VU University Medical Center (Medisch Etische Toetsingscommissie Vrije Universiteit medisch centrum), 09/03/2012, ref. 2011/36

Study design

Single-centre randomised controlled trial, blinded for the patient and examiners of the saved 3D images with respect to used type of gel (double-blind)

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Healthy participants with abnormal uterine bleeding or infertility and suspected for having a intrauterine abnormality


Intervention group: The use of ExEmgel.
Control group: The use of Endosgel.
Both gels are used in daily practice (in the VU University Medical Center [VUmc]) during GIS.

Intervention type



Not Applicable

Drug names

Primary outcome measures

AUC of continuous registered pain score (continuous VAS) during gel installation and following sonography.

Secondary outcome measures

1. Pain score (AUC using continuous pain registration) of the entire procedure and of specific parts of the procedure
2. Subjective reported VAS score
3. Image quality
Various prognostic factors will be registered.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Woman with abnormal uterine bleeding or infertility and suspected for having an intrauterine abnormality
2. Age 20-80 yr

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Pregnancy or premenopausal women in the luteal phase without use of contraception
2. Pelvic Inflammatory Disease (PID)
3. Risk of malignancy
4. Contraindication for the use of NSAIDS
5. Known allergy for chlorhexidine
6. Inability to understand Dutch or English

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Boelelaan 1117

Sponsor information


VU University Medical Center (Netherlands)

Sponsor details

c/o Prof. H.A.M. Brölmann
Boelelaan 1117
+31 (0) 204444444

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Dutch Ministry of Education, Culture and Science (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

VU University Medical Center (Netherlands)

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