David Walker on Intralipid Infusions in IVF treatment
At Bath Fertility, we are always keen to offer up to date treatments to provide our patients with the best chance of conceiving. There are many claims of adjunctive treatments in IVF – some of which may have some scientific merit, others that do not.
We have always been sceptical about the benefit of intralipid infusions in IVF treatments and a recent press statement from the President of the Royal College of Obstetricians and Gynaecologists supports our view. Not only is there no evidence supporting its use, there may be risks:
Public Health England has recently become aware of three women who developed severe sepsis following administration of intravenous Intralipid 20%. This is believed to be as a result of poor practice in the administration leading to contamination of the product.
It is essential to alert Fellows and Members of the risks associated with Intralipid infusion and the distinct lack of evidence for its use in assisted conception and recurrent miscarriage.
What is Intralipid?
Intralipid is a sterile, non-pyrogenic fat emulsion prepared for intravenous administration as a source of calories and essential fatty acids. It is made up of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin and water for injection. Whilst initially used for parenteral feeding and the delivery of essential fatty acids, Intralipid is also used as a vehicle for drug delivery and most recently in the treatment of toxicity caused by local anaesthetic and other lipid-soluble drugs. Intralipid use and assisted conception / recurrent miscarriage
An abnormal immune response has been suggested to underlie some cases of ‘unexplained’ infertility, IVF failure and recurrent miscarriage. The traditional immunological perspective of pregnancy being that the semi-allogeneic fetus will be rejected unless the maternal immune system is suppressed. A variety of immune therapies including steroids and intravenous immunoglobulin have been administered to women in the expectation of improving the chance of a successful pregnancy.
However, published studies have included differing populations; lacked statistical power; used differing dosage regimes and been confounded by co-prescribing of additional medications. Importantly, systematic reviews have not supported the use of immune-modulating therapies to women with reproductive loss. Intralipid is increasingly being prescribed to women undergoing IVF and those with a history of recurrent miscarriage.
However, there is no rationale for its use. There are no published randomised controlled trials assessing its efficacy. Risks and Warnings regarding Intralipid: In addition to the risk of sepsis, the manufacturer also cites warnings regarding the risks of hypercoagulation – cases of Disseminated Intravascular Coagulation have been reported – and that the carcinogenic and mutagenic potential of Intralipid has not been assessed.
The FDA advises that there have been no animal studies of the use of Intralipid and it is not known whether Intralipid can cause fetal harm when administered to a pregnant woman or can affect her reproductive capacity.