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Innovative, Simple, Safe:
Foam is the Future

Hysterosalpingo Foam Sonography (HyFoSy) is a new and attractive alternative for tubal patency assessment and diagnosis in subfertile women or women with known or suspected infertility.1,2

•A patient -friendly ultrasound procedure: less painful than HSG3
•Convenient: can be performed in the gynecologist's office
•Pregnancy: similar pregnancy outcomes compared to HSG 4

Improved level of details and accuracy

ExEm® foam is highly echogenic and offers an exceptional visualization of the fallopian tubes.

Designed by gynecologists,
for an improved patient and doctor experience

"To overcome the usual drawbacks of available HSG, there was a need for an easier, less invasive procedure, with a better visualization of fallopian tubes"

Both Dr. Exalto and Prof.Dr. Emanuel envisioned an easier, less invasive tubal patency procedure with better visualization capabilities, without the burdens which comes from HSG.

Tubal disease is among the most common causes of infertility and is the primary diagnosis in approximately up to 25% of female infertility cases 5. An inaccurate fallopian tube evaluation can lead to unnecessary procedures — such as tubal reconstructive surgery or in vitro fertilization — when other methods of conception are possible.

Hysterosalpingo Foam Sonography (HyFoSy) is a patient-friendly ultrasound-based procedure for tubal patency assessment and diagnosis in subfertile women or women with known or suspected infertility. The HyFoSy procedure uses ExEm® Foam, a high echogenic medium that enables accurate diagnostic procedure without iodine, X-ray or laparoscopy.

Safety and simplicity. Every step of the way.

Prepare ExEm® Foam according to the instructions for use.

Place catheter on syringe and insert a small amount of foam into the catheter to expel air

Place the side opening speculum, then the catheter into the cervix

Remove speculum and place TVUS transducer under the catheter

Infuse 1ml foam; check access to uterine cavity

 

Confirm adequate placement of the catheter, then gently infuse 2-3ml to fill the tubes

Start longitudinally, spot fundus

Rotate to transverse plane. Spot intramural of right tube

Continue to distal. Look for flow secondary. Look for spillage of foam intra-abdominally

Repeat at left side (be prepared for a winding tube)

 

Remove the probe and catheter

Making the uncomfortable, more comfortable.

The HyFoSy procedure using ExEm® Foam allows to inspect the fallopian tubes and its relation to other pelvic organs/structures. It also provides extra details for the assessment of the patient's subfertile situation. It is performed by a qualified sonographer and is technically an ultrasound examination that quickly helps to localize fallopian tubes and visualize tube abnormalities.

BETTER RESULTS, BETTER PATIENT COMFORT:

Efficacy & Effectiveness:

The HyFoSy procedure has shown a high detection rate of tubal obstruction and good reproducibility with concordances up to 100% with HSG, and up to 97% with laparoscopy 6.

Less invasive & more patient-friendly:

The HyFoSy procedure enables an accurate diagnostic procedure without iodine, X-ray or laparoscopic surgery. It is also significantly less painful than HSG": VAS pain score 50+% less compared to HSG3

Convenient & less anxiety:

The HyFoSy procedure is an ultrasound-based procedure that can be performed in a calm environment that may reduce patient anxiety7: the gynecologist's office.

Reliable:

Over 1 million fallopian tubes assessed worldwide.

Pregnancy

The HyFoSy procedure provides similar pregnancy outcomes compared to HSG4.

High diagnostic efficacy:

ExEm® Foam is a highly echogenic medium and offers an exceptional visualization of the fallopian tubes. Moreover, studies confirm that, using the right imaging techniques, the accuracy of a HyFoSy procedure using ExEm® Foam does not significantly differ from what you achieve through laparoscopy. The same studies demonstrate that HyFoSy has the ability to achieve significantly higher accuracy than 2D saline and air1.

HYFOSY VS. OTHER TECHNIQUES

value of the HyFoSy procedure
assessment
technique
Xray-HSG
HyFoSy
Laparoscopy
(lap&dye)
Myometrial anatomy
•
•
Cavity shape
•
•
Cavity anatomy/abnormality
•
•
Endometrial thickness
•
Tubal anatomy
•
•
•
Tubal patency
•
•
•
Peritoneal contrast spread
•
•
•
Ovarian anatomy/abnormality
•
•
Ovum-pickup anatomy (relation of ovary/tube)
•
•

Technology

Innovation meets safety – And simplicity:

ExEm® Foam is a medium made of ExEm® Gel - hydroxyethyl cellulose & glycerol and ExEm® Water - purified water. When vigorously mixed, a highly echogenic foam containing 127,000 micro-air bubbles per ml is formed and can easily be seen by a qualified sonographer using 2D or 3D transvaginal ultrasound techniques.

The ExEm® Foam kit

ExEm® Foam Kit:
With the ExEm® Foam Kit, a foam can be created for Hysterosalpingo Foam Sonography. By diluting the ExEm® Gel with ExEm® Water, a foam is created which enables a fast and simple distension of the walls of the fallopian tubes.
ExEm® foam kit with ExEm® catheter:
Performance. All in one. The ExEm® Foam Kit FK05-LN970 contains also an ExEm® catheter with cervical cannula LN970. Specially developed for sonohysterosalpingography and HyFoSy. ExEm® catheter, also known as GIS catheter is a patient-friendly catheter by design with a flexible cervical tip.

Ultrasound machine requirements

Any 2D ultrasound machine operated by a qualified sonographer can be used for the ExEm® Foam procedure. 3D and 2D/3D High Definition Flow (HDF) Doppler ultrasound may offer enhanced accuracy and faster recognition of tubal patency in subfertile women or women with known or suspected infertility.
Learn more about ExEm® Foam
Give your subfertile patients or patients with known or suspected infertility the option of a reliable, patient-friendly, and ultrasound-based procedure for tubal patency assessment.
Learn more about ExEm® Foam today, and sign up for our newsletter to stay informed
Where can you buy ExEm® Foam? We partner with ExEm® Foam distributors across various countries.
ORDER HERE

Here's what patients and doctors say

Over a half-million patients around the world have experienced a tubal patency procedure with ExEm Foam.
Here is some of their feedback:

❝
❝Trying to conceive brings enough insecurities. Having the doctor explain the test results and discuss the next step in my fertility journey straight away, gave me clarity and reduced anxiety❞.
_PATIENT TESTIMONIAL
❝Trying to conceive brings enough insecurities. Having the doctor explain the test results and discuss the next step in my fertility journey straight away, gave me clarity and reduced anxiety❞.
_PATIENT TESTIMONIAL
❝Trying to conceive brings enough insecurities. Having the doctor explain the test results and discuss the next step in my fertility journey straight away, gave me clarity and reduced anxiety❞.
_PATIENT TESTIMONIAL
☰
ExEm® Foam Kit is a procedure pack consisting of CE marked components (Medical devices ExEm® Gel (class Is) and Combifix® Adapter (Class IIa)). With ExEm® Foam, a foam can be created for Hysterosalpingo Foam Sonography (HyFoSy).
Home Clinical image gallery Peers to peers The science News & events Resources Distributors
Contact Information:
IQ Medical Ventures
Giskit MD B.V.
Veerkade 5F
3016 DE Rotterdam
Netherlands
Office +31 102619100
Important Safety Information:
The ExEm® Foam Kit is intended for use by medical professionals skilled in ultrasound tubal patency testing. The ExEm® Foam Kit is intended for single use only.
Contraindications
• Do not use the gel foam during pregnancy.
• Do not use the gel foam if the patient may be pregnant.
• Do not use the gel foam between ovulation and menstruation.
• Do not use the gel foam in the presence of active pelvic infection, sexually transmitted diseases and profuse bleeding.
• Do not use the gel foam in case of allergy to any of the constituents of ExEm® Gel (hydroxyethylcellulose, glycerol and purified water).
READ MORE
Precautions and warnings:
• The ExEm® Foam Kit should be considered as contaminated medical waste after use.
• Do not use if package has been previously opened or damaged.
• This device is intended for single use only. Any foam not used in one examination session must be discarded.
• Do not reuse, re-sterilize or autoclave. Reuse of single use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient. Cleaning, disinfection and sterilization may compromise essential material and design characteristics leading to device failure. The manufacturer will not be responsible for any direct, incidental or consequential damages resulting from re-sterilization or reuse.
• Do not use the ExEm® Foam Kit after the expiry date of the ExEm® Gel, the ExEm® Water, the coupling device and/or the GIS catheter.
• Do not use the ExEm® Gel and the ExEm® Water separately for Hysterosalpingo Sonography.
• The ExEm® Gel and the ExEm® Water are not to be used for injections.click here for instructions for use, including the Contraindications and Warnings.
Note: Some patients may experience painful uterine contractions, vasovagal reaction, abdominal pain, fluid loss or spotting. These symptoms are well known and related to all intra-uterine and tubal patency testing procedures. Pain treatment should be according to local protocol.

References:
1. Ludwin I., Ludwin, A. et al. Accuracy of hysterosalpingo-foam sonography in comparison to hysterosalpingo-contrast sonography with air/saline and to laparoscopy with dye. Human Reproduction 2017, 32(4):758–69.
2. Riganelli L., Casorelli A. et al. Ultrasonography reappraisal of tubal patency in assisted reproduction technology patients: comparison between 2D and3D-sonohysterosalpingography. A pilot study. Minerva Ginecologica 2018, 70(2):123-28.
3. Dreyer K , Out R , Hompes PGA , Mijatovic V . Hysterosalpingo-foam sonography, a less painful procedure for tubal patency testing during fertility workup com- pared with (serial) hysterosalpingography: a randomized controlled trial. FertilSteril 2014;102(3):821–5 sept.
4. Nienke van Welie, Joukje van Rijswijk, Kim Dreyer, et al. Can hysterosalpingo-foam sonography replace hysterosalpingography as first-choice tubal patency test? A randomized non-inferiority trial, Human Reproduction, 2022; deac034, https://doi.org/10.1093/humrep/deac034.
5. According to the the American Society for Reproductive Medicine (ASRM). https://www.asrm.org/globalassets/asrm/ asrm-content/news-and-publications/practice-guidelines/for-non-members/role_of_tubal_surgery_in_the_era_of_art.pdf.
6. Serrano González, L., Pérez-Medina, T., Bueno Olalla, B. et al. Is hysterosalpingo-foam sonography (HyFoSy) more tolerable in terms of pain and anxiety than hysterosalpingography (HSG)? A prospective real-world setting multicentre study. BMC Women’s Health 22, 41 (2022). https://doi.org/10.1186/s12905-022-01606-3.
7. Engels V , Medina M , Antolín E , Ros C , Amaro A , De-Guirior , et al. Feasibility, tolerability, and safety of hysterosalpingofoam sonography (HyFoSy). Multi- center, prospective Spanish study. J Gynecol Obstet Hum Reprod 2020:102004 23 nov.
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