Thirteen add-ons have been evaluated by a British public agency. In U.S., fertility patients and doctors are mostly on their own.
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BY RON SHINKMAN
The United Kingdom is not only the birthplace of IVF, but of a distinctive ratings system of “add-on” services unique among developed countries.
In 2019, U.K.’s Human Fertilisation and Embryology Authority – an affiliate of its National Health Service – introduced a rating system on add-on services. First known as “Traffic Light,” the ratings initially followed a color-coded system of green, yellow and red. However, the ratings expanded earlier this year into five colors, according to an HFEA spokesperson.
A green rating means the add-on can improve the outcome; yellow means improvement is unclear. A black rating means the add-on has no impact on the treatment outcome. A red rating means the add-on could actually degrade the chance of a positive outcome, or even pose safety concerns for the patient. A gray rating means there is not enough clinical evidence to evaluate the add-on.
The ratings are based on research and analyses conducted by an HFEA subcommittee called the Scientific and Clinical Advances Committee. Currently, 13 add-ons have received grades. They include assisted hatching, endometrial scratching, PGT-A and time-lapse imaging and incubation. The ratings are for the procedures only, and do not apply to individual companies. However, “in line with the HFEA Code of Practice, clinics must give patients a clear idea of what any treatment add-on will involve, how likely it is to increase their chance of a successful pregnancy…how much it will cost, and link to the HFEA ratings system,” said HFEA CEO Peter Thompson said in a statement on the agency’s website.
No add-on has received a green rating. All-cycle elective freezing, endometrial scratching and a process known as “EmbryoGlue” have all received yellow ratings. IVIG, the use of glucocorticoids and endometrial receptivity testing have all received red ratings. IMSI, assisted hatching, immunological testing and treatments for fertility and intrauterine cultures all received gray ratings.
“I don’t think there is anything like this in any part of healthcare in the U.S.,” said Sean Tipton, chief advocacy and policy officer for the American Society for Reproductive Medicine. Tipton added that the fact the United Kingdom has a nationalized single-payer healthcare system means the government takes a much larger role compared to other countries in assessing and rating treatments.
Kate Devine, M.D., an OBGYN who works as medical director and chief research officer for Shady Grove Fertility, noted that patients and clinicians in the U.S. are largely on their own regarding the use of add-ons.
“Unfortunately, in the U.S. patients and their physicians must decide on a case by case basis whether there is enough evidence to warrant the additional cost, time, and/or discomfort entailed by IVF add-ons,” she said.
That’s further compounded by the fact that many fertility patients have done deep research on reproductive medicine and are highly driven to succeed. “They are often willing to try anything and everything, and sometimes beg for unvalidated add-ons,” Devine said.
As for Shady Grove, Devine said that it prefers to offer only add-ons that have a clear benefit, ideally proven through clinical trials. Devine said the practice conducted a randomized controlled trial on endometrial receptivity testing that was published in JAMA late last year. Igenomix, the biotech company that created the add-on, collaborated, by providing free embryo genetic testing and endometrial receptivity testing to patients who participated in the study. The conclusion: Such testing doesn’t improve the chances of a pregnancy. “It should not be offered on a routine basis,” Devine said.
As for Shady Grove, Devine said that it prefers to offer only add-ons that have shown efficacious results in clinical studies. Devine said the practice sponsored and was the investigator for a study published in JAMA late last year on endometrial receptivity testing. The study was conducted with the cooperation of Igenomix, the biotech firm that created the add-on. The conclusion: Such testing doesn’t improve the chances of a pregnancy. “It’s not something that should probably be offered,” Devine said.
What guidance is offered to patients in the U.S. is more informational than advisory. For example, ASRM has materials on its website regarding add-ons and research about their outcomes, but none of the material is rated in any fashion.
“Our (medical) practice committees and other committees are in the business of trying to inform our members with the latest research so they can better inform their patients,” Tipton said.
However, translating such communications for the general public is complicated. Too high a level of detail overcomplicates the ability to make a decision about a specific add-on. But Tipton also believes that the Traffic Light system oversimplifies the issue.
“There is no way to control (for a specific patient),” he said. “Maybe it’s a green light for me, and maybe it’s a yellow light for somebody else, based on what the underlying conditions are.” Tipton noted that may be the “price to pay” to have a ratings system that is simple for everyone to understand.
Whether the U.S. ever gets an official rating system for add-ons remains in the air. But Devine noted that patients are going to keep coming in for treatment no matter what.
“Until these things are proven, the better part of valor is to keep calm and transfer another embryo,” she said.
The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser
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