IVF Add ons and how Patients are at Risk of Being Mislead

With approximately 48 million (1) couples worldwide being affected by infertility (WHO, 2020), they are likely to turn to assisted reproductive technology (ART). To improve the chances of ART various treatments are offered by fertility clinics. IVF add-ons are additional, 0000 non-essential IVF procedures offered to patients, often at an extra cost with the intent of increasing conception rates (HFEA, 2020).   Despite numerous clinics offering these additional treatments, the findings for these add-ons are controversial as many add-ons show conflicting evidence or no evidence from randomized control trials (RCTs) on their efficacy. The RCTs should show an increased live birth rate (LBR). But the evidence available didn’t prove that there is an increase in LBRs or that the increase is insignificant.   In a few cases, the increase may be significant; still, there are not enough studies to support the increase- and there may be flaws in the studies. Typically, patients with fertility issues are left in a vulnerable position when diagnosed with infertility. The majority are desperate to conceive that they will consider any treatment offered and at any cost, even if there are risks involved or the procedure is costly.   The Add-ons offered to Couples with infertility The Human Fertilization & Embryology Authority (HFEA) is the UK's fertility regulator and offers consultation regarding IVF add-ons. On their website (2), the following are classified as IVF add-ons: Artificial egg activation calcium ionophore Assisted hatching Elective freeze all cycles Endometrial receptivity array Endometrial scratching Hyaluronate enriched medium Immunological tests and treatments for fertility Intrauterine culture Physiological intracytoplasmic sperm injection Intracytoplasmic sperm injection Pre-implantation genetic testing for aneuploidy Time-lapse imaging.    However, since new treatments have become available daily, more add-ons could become available. In some cases, holistic medicine can be classed as an add-on treatment.   The Add-ons rating The add-ons listed on the HFEAs website, the HFEA rates them using a traffic light system. A green-rated add-on has more than one high-quality RCT, indicating that it is successful at improving the chances of pregnancy. For example, Amber is given as an add-on where RCTs show conflicting evidence on its efficacy; if no evidence exists from RCTs, the add-on is rated red.    These traffic light ratings are regularly reviewed by the HFEA.   The HFEA is the UK’s regulator; therefore, the use of add-ons differs in each country, and their recommendations can be different too. The American Society of Reproductive Medicine also offers advice on some add-ons for US citizens. The Lack of Evidence and Challenges Patients encounter These add-ons lack robust evidence regarding the mechanisms behind how they work. Still, patients will be willing to try the procedure as they are hopeful it will help them conceive their much-wanted child (S Rautakallio-Hokkanen, 2022). Studies on the efficacy of these add-ons and their safety are scarce. Despite the paucity of research, private clinics continue to offer these procedures to patients.   For patients to make an informed decision, they should be presented with details regarding the procedure, including outcomes from any studies, the risks, and side effects. Some procedures do not involve risks such as time-lapse imaging, compared to others with severe risks and side effects, including immunological tests.   The scientific mechanisms behind many of the add-ons remain unclear, and for others such as time-lapse imaging, no scientific mechanisms exist; and this is just a way of observing the blastocyst while it grows. Despite the data available regarding mechanisms, the data is outdated and scarce. Time and money should be invested in more studies for clinicians to be aware of the mechanisms behind the treatments before offering them to patients unaware of what the risks.   Lack of Consumer Laws and Research In the UK there is currently no formal evidence on consumer laws for the IVF business to protect patients. This means that patients are at risk of being taken advantage of by clinics that see patients as paying customers without caring about their wellbeing (Grant, 2020). The HFEAs patients’ survey revealed that only 33% of patients said that clinics have clearly outlined the risks of the procedure (3). With the high cost of IVF, it is unfair that patients are forking out more cash for what they believe will increase their chances of conceiving. And in reality, there is no evidence regarding this, or the evidence available is enough to justify the application of these add-ons.   Laws must be put into place to protect patients, and that information given by clinics is moderated and ideally verified. This ensures that the information provided is accurate and not misleading for patients, as clinics are making a massive profit from IVF add-ons. Also, it is unethical to offer the procedures if there is no evidence supporting their efficacy in increasing live birth rates.   Also, patients may have to take matters into their own hands and research the procedures using online journals. However, there is the issue that this is time-consuming, and the language can be complicated; hence, patients are unlikely to do this. The reason is that patients always trust their clinicians to present all of the evidence, yet this is not always the case.   More research is necessary on the use of add-ons and their efficacy. For instance, no RCTs can are available for intrauterine culture. This is likely due to patients not wanting to participate as there is a chance they will have the control and only believe the add-on would be effective. Since having the control would not increase their pregnancy rate, many do not want to participate. In conclusion In the future, more studies should become available to ensure that the evidence is assessed based on the efficacy of the treatment, and traffic light ratings to be changed as seen fit. Also, consumer protection laws should ensure that vulnerable patients are not misled and taken advantage of by private clinics taking patients' money in exchange for an IVF add-on with no evidence supporting its efficacy in increasing their chances Nilesh of conceiving.  Written by: Rachel McGhee