The Human Fertilization and Embryology Authority in the UK has issued a new rule requiring facilities to provide patients with full information on in vitro fertilization or IVF add-on services.
Under this code, doctors are required to have a total disclosure to their patients about the clinical efficacy of extra procedures on top of the IVF. This is in light of a study showing that an increasing number of clinics are charging patients extra to avail other services that are not tested in clinical trials or did not yield positive or negative results.
"Clinics tell us it's due to patient pressure," said Sally Cheshire, HFEA chairwoman. "We're saying clinics need to be robust and ethical in what they offer, particularly if they're asking patients to pay for those treatments."
Potentially Dangerous IVT Treatment Add-Ons
Approximately 70 percent of IVF clinics in London are offering an add-on treatment on top of the standard fee of £3,000 to £5,000 or about $4,000 to $6,700. Cheshire said there is no evidence-based data to support the effectiveness of these treatments, and patients could be facing harmful side effects.
In particular, Cheshire raised concern over the reproductive immunology treatments that target the mother's immune system. Women who are trying to conceive are exposed to adverse events such as chronic infections, septicemia or blood poisoning, and severe allergic reactions.
Some fertility treatments offer assisted hatching, which helps the embryo to break out of its protein sac using acid, laser, or other tools. Time-lapse imaging is also an add-on procedure that tracks the IVF embryo to determine which one is the most viable for pregnancy.
These procedures cost £400 to £500 or about $533 to $670 and £750 or about $1,000 respectively. The National Institute for Health and Care Excellence said that assisted hatching and time-lapse imaging do not show indications of increased live births.
Increased Live Births Using IVF
Women below 35 years old have 29 percent successful fertility treatment, the highest it has ever been since 1991. The HFEA is also working in conjunction with IVF clinics to reduce the rates of multiple births as it poses risks to the mother and child. The incidence of multiple births decreased from 28 percent to 11 percent in 2016.
Regulators use randomized controlled trials as bases for the safety and efficacy of treatments in humans. HFEA implements a color coding scheme applicable to IVF extra procedures. For example, treatments that have more than one clinical trial supporting its efficacy and safety are labeled green. Those that warrant further research are labeled yellow. Red is designated to ones that do not show that it is effective and safe like assisted hatching.
Shopping For IVF Clinics
A 2016 analysis published in the British Medical Journal reported that the proliferation of IVF clinics encouraged patients to basically shop for their preferred providers.
"Patients may be desperate, and therefore vulnerable, and we have shown that fertility interventions are offered without supporting evidence to back up claims of effect," the authors said.