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The Foam procedure (HyFoSy)

A patient-friendly tubal patency testing for subfertile women or women with known or suspected infertility.

About us What is infertility? What is HyFoSy? Benefits how it works Find a location Contact us

What is infertility?

Did you know that 1 out of 6 couples face infertility issues?
Infertility occurs after 12 months of free and unprotected intercourse during which pregnancy was not achieved.
There are numerous causes of female infertility:
• Ovulation disorders: Ovulating infrequently or not at all accounts for most cases of infertility. Problems with the regulation of reproductive hormones by the hypothalamus or the pituitary gland or problems in the ovary can cause ovulation disorders.
• Damage to fallopian tubes (tubal infertility) : Damaged or blocked fallopian tubes keep sperm from getting to the egg or block the passage of the fertilized egg into the uterus. Causes of fallopian tube damage or blockage can include:
Pelvic inflammatory disease, an infection of the uterus and fallopian tubes due to chlamydia, gonorrhea or other sexually transmitted infections
Previous surgery in the abdomen or pelvis, including surgery for ectopic pregnancy, in which a fertilized egg implants and develops somewhere other than the uterus, usually in a fallopian tube.
• Endometriosis: occurs when tissue that typically grows in the uterus implants and grows in other places. This extra tissue growth — and the surgical removal of it — can cause scarring, which can block fallopian tubes and keep an egg and sperm from uniting.
Endometriosis can also disrupt implantation of the fertilized egg. The condition also seems to affect fertility in less direct ways, such as damage to the sperm or egg.

• Cervical: When the mucus present in the uterine cervix is hostile to the passage of spermatozoa due to a lack of estrogen, infectious factors, or previous surgeries that have damaged the cervical glands.
• Uterine: presence of congenital malformations of the uterus, fibroids, or adhesions within the uterine cavity or the presence of inflammatory
• Unexplained infertility: In some cases, the cause of infertility is never found. A combination of several minor factors in both partners could cause unexplained fertility problems. Although it's frustrating to get no specific answer, this problem can correct itself with time. But you shouldn't delay treatment for infertility.
Fortunately, there are many safe and effective therapies that significantly improve the chances of pregnancy.

source: https://www.mayoclinic.org/diseases-conditions/female-infertility/symptoms-causes/syc-20354308

Everything you need to know about the Foam procedure

Are you trying to conceive?
Trying to conceive can be hard, both physically and emotionally.
If you have been trying to conceive for over a year without success (or sooner if you are over 35 years old), you should talk to your gynecologist or fertility specialist and start a fertility check-up.
At an early stage of your fertility check-up, your gynecologist will examine the patency of your fallopian tubes. In other words, your gynecologist will examine if your fallopian tubes are open or blocked. Blocked or damaged fallopian tubes may be one of the reasons you have difficulty to conceive.
This condition is what we refer to as fallopian tubal disorder or tubal disorder.

What are the current alternatives?
There are two main techniques to assess fallopian tube patency. Laparoscopy (surgery) and hysterosalpingography (also known as HSG).
For many women, both of these procedures are uncomfortable and painful experiences.
The Foam procedure is the latest innovation in tubal patency assessment and has already challenged the two established methods of tubal patency tests offering a reliable patient-friendly, ultrasound-based procedure.

What is the Foam procedure?
The Foam procedure, also referred to as Hysterosalpingo Foam Sonography or HyFoSy in scientific terms, is a simple ultrasound test aimed to determine whether your fallopian tubes are open or blocked.
The Foam procedure can be performed in an environment that you are familiar with: your gynecologist’s office.

Why is it important to check the fallopian tubes?
Fallopian tubes are an essential part of a woman’s reproductive system. They are the tubal structures that connect the ovaries to the uterus. Open fallopian tubes are important to become pregnant and are the place where sperm and eggs initially meet before an embryo later travels to attach to the uterus.
If both of your fallopian tubes are blocked, the sperm and the egg cannot meet and natural conception will not be possible. At least one patent tube is needed for natural conception.

What is the medium used during the Foam procedure?
The medium used during the Foam procedure is called ExEm® Foam.
ExEm® Foam is made of ExEm® Gel – hydroxyethyl cellulose & glycerol and ExEm® Water – purified water.

How it works

A FAST, GENTLE, AND EFFECTIVE SOLUTION

Why is the Foam procedure a patient-friendly alternative?

The foam procedure can be performed in your gynecologist’s office, allowing immediate results and diagnosis, so that you can continue your fertility journey without delay.

No radiation.
No iodine.

The diagnosis is made by transvaginal ultrasound.

Convenient

Your gynecologist can perform the ultrasound-based procedure in their office. You will not be asked to visit a radiologist after your appointment with your gynecologist.

Least painful procedure

Studies confirm that the Foam procedure is 50% less painful than HSG¹

Fewer appointments:

Get immediate results and diagnosis during your appointment.

Tried and trusted:

Over 1 million fallopian tubes assessed worldwide.

HSG VS. HyFoSy

Comparison table

HSG hysterosalpingography

Hysterosalpingo Foam Sonography (HyFoSy) with ExEm® Foam

Radiation exposure

Yes

Need to resort to radiology for the procedure

Yes

Equipment used

X-ray

Ultrasound

Contrast used

Iodized contrast medium

ExEm® Foam

Fast result

Yes

Source: https://exemfoam.it/2021/03/10/procedura-con-exem-foam-vs-hsg/

The Procedure in a nutshell

Safety and simplicity, every step of the way

The HyFoSy procedure is usually completed within 10 minutes.

Step 1:

You will be asked to lie on your back on the examination table with your feet in stirrups. A routine transvaginal (internal) scan is carried out first.

Step 2:

A speculum (instrument) is then placed in the vagina (like having a smear). A catheter (tube) is then gently introduced into the cervix. The speculum is removed, and the ultrasound probe is inserted into the vagina.

Step 3:

ExEm® Foam is gently infused through the catheter into the uterus and the fallopian tubes. The flow of the foam can be seen on the ultrasound.

Step 4:

Patency of the fallopian tubes will be assessed and determined using small movements of the ultrasound probe. When completed, the ultrasound probe and catheter are removed.

Step 5:

Afterwards, you and your gynecologist will discuss together the next steps in your fertility journey.

What to know before, during, and after the procedure

Before the procedure.

The Foam procedure should take place in the pre-ovulatory phase of your menstrual cycle (cycle days 6 through 11). This is after the bleeding has stopped, but before ovulation occurs.

It’s important to have a negative pregnancy test within 24 hours before the procedure takes place.

You should eat and drink as normal on the day of the procedure.

Prior to the procedure, you will be asked to empty your bladder to ensure optimal visualization.

After the procedure.

After the procedure, you may notice a small amount of foam discharge and/or spotting. This is normal and a sanitary pad will be provided if needed.

Your doctor will discuss the results and recommended steps with you

Contraindications and precautions

The Foam procedure can only be used when you are not pregnant and when there is no bleeding. The Foam procedure cannot be used if there is an active pelvic infection or sexually transmitted diseases. The procedure will not be performed if the routine transvaginal scan shows that one or both fallopian tubes are swollen (hydrosalpinx).

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.

Where is the Foam procedure (HyFoSy) performed?

Feel free to look for the nearest place to you where the Foam procedure (or HyFoSy) is performed. Please note that the tool is new, and more locations will be added in the near future. Now, only data for the United Kingdom is available. If you are located outside of the UK, please feel free to contact us directly.

About ExEm® Women’s Health

Moving women’s health forward

ExEm® Women's health is committed to raising awareness of issues affecting women worldwide and finding solutions that make their lives more comfortable.We work closely with healthcare professionals to innovate and to keep propelling women’s health technology forward focusing initially on the issues surrounding fertility.
In fact, we envision a better, simpler, and less invasive fertility diagnosis for every woman. Drawing on extensive expertise and experience, the team identifies and develops innovative products that better meet the needs of today’s patients and healthcare professionals.

Resources

Patient Brochure

click to download

Learn more about ExEm® Foam

When you’re ready to take the next step in your fertility journey, speak to your gynecologist about the Foam procedure. Learn more about it today, and sign up for our newsletter to stay informed

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

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).

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: