Intralipid® is a sterile intravenous lipid emulsion originally developed for nutritional support.

In reproductive medicine it may be prescribed off-label for selected patients as part of fertility treatment.

It may be considered in women with:

☐ Recurrent implantation failure

☐ Recurrent pregnancy loss

☐ Suspected reproductive immune dysfunction

☐ Recurrent IVF failure

☐ Other fertility indication

IMPORTANT INFORMATION

I understand:

☐ The use of Intralipid® for IVF or reproductive immunology is off-label.

☐ This means it is being prescribed outside its primary TGA-approved indication.

☐ My fertility specialist believes this treatment may be appropriate in my individual circumstances.

☐ Evidence regarding effectiveness remains limited and evolving.

☐ Treatment may not improve implantation or pregnancy outcomes.

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EXPECTED BENEFITS

Potential benefits discussed include:

☐ Possible improvement in embryo implantation.

☐ Possible improvement in pregnancy rates.

☐ Possible reduction in immune-mediated implantation failure.

☐ Possible reduction in recurrent miscarriage in selected patients.

I understand these benefits cannot be guaranteed.

ALTERNATIVE OPTIONS

Reasonable alternatives discussed include:

☐ Proceeding with IVF without Intralipid®

☐ Other fertility treatment strategies

☐ Further fertility investigations

☐ Expectant management

☐ No treatment

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BEFORE STARTING TREATMENT

I understand my clinician may review:

☐ Allergy history

☐ Soy allergy

☐ Egg allergy

☐ Peanut allergy

☐ Liver disease

☐ Pancreatitis

☐ Disorders of fat metabolism

☐ Pregnancy status

☐ Current medications

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I HAVE INFORMED MY CLINICIAN IF I HAVE​

Egg allergy

Soy allergy 

Peanut allergy

Severe food allergies 

Hyperlipidaemia

Pancreatitis 

Liver disease

Kidney disease

Previous reaction to lipid infusion 

COMMON SIDE EFFECTS

☐ Mild headache

☐ Nausea

☐ Fatigue

☐ Metallic taste

☐ Feeling warm

☐ Flushing

☐ Mild dizziness

☐ Cannulation discomfort

☐ Bruising

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MATERIAL RISKS

Although serious complications are uncommon, I understand Intralipid® therapy may be associated with:

☐ Allergic reactions

☐ Infusion reactions

☐ Fever

☐ Chills

☐ Rash

☐ Urticaria (hives)

☐ Low blood pressure

☐ High blood pressure

☐ Infection related to intravenous access

☐ Phlebitis

☐ Extravasation

☐ Hypertriglyceridaemia (rare)

☐ Fat overload syndrome (very rare)

☐ Requirement for emergency treatment

☐ Hospital admission

☐ Rare life-threatening allergic reaction (anaphylaxis)

INFUSION REACTIONS

Symptoms may include:

☐ Itching

☐ Rash

☐ Hives

☐ Chest tightness

☐ Wheezing

☐ Shortness of breath

☐ Facial swelling

☐ Dizziness

☐ Fever

☐ Chills

☐ Feeling faint

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If these occur:

• the infusion may be slowed

• the infusion may be stopped

• emergency medications may be administered

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LIMITATIONS OF TREATMENT

I understand:

☐ Intralipid® is not a guaranteed fertility treatment.

☐ Treatment may not improve implantation.

☐ Treatment may not reduce miscarriage.

☐ Treatment may not result in pregnancy.

☐ Additional IVF treatment may still be required.

☐ Other fertility factors remain important.

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AFTER MY INFUSION

I should seek medical attention if I develop:

☐ Difficulty breathing

☐ Facial swelling

☐ Persistent rash

☐ Fever

☐ Increasing pain or swelling at the cannula site

☐ Persistent vomiting

☐ Chest pain

☐ Any symptoms that concern me

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PATIENT ACKNOWLEDGEMENT

I acknowledge that:

☐ My fertility diagnosis has been discussed.

☐ The reason Intralipid® has been recommended has been explained.

☐ I understand this treatment is off-label for fertility treatment.

☐ I understand evidence supporting its effectiveness remains limited and evolving.

☐ Expected benefits have been discussed.

☐ Reasonable alternatives have been discussed.

☐ I understand the common side effects.

☐ I understand the material risks relevant to my circumstances.

☐ I understand serious allergic reactions are uncommon but possible.

☐ I understand emergency treatment may become necessary.

☐ I understand treatment success cannot be guaranteed.

☐ I have had sufficient opportunity to ask questions.

☐ My questions have been answered

☐ I understand I may withdraw my consent before treatment commences.

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CONSENT TO TREATMENT

I voluntarily consent to receiving Intralipid® 20% intravenous lipid emulsion therapy as recommended by my treating fertility specialist.

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I understand this treatment is prescribed off-label for reproductive medicine and assisted reproductive technology and that my decision to proceed is based on the discussion I have had with my treating clinician regarding the potential benefits, limitations, risks and available alternatives.

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