Do à la carte menus serve infertility patients? The ethics and regulation of in vitro fertility add-ons

We discuss the regulation of in vitro fertilization add- ons, the ethics of providing unproven treatments, and how to inform patients of uncertainties.

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Volume 112, Issue 6, Pages 973–977

Authors:

Jack Wilkinson, Ph.D., Phillipa Malpas, Ph.D., Karin Hammarberg, Ph.D., Pamela Mahoney Tsigdinos, M.A., Sarah Lensen, Ph.D., Emily Jackson, F.B.A., Joyce Harper, Ph.D., Ben W. Mol, M.D, Ph.D.

Abstract:

Add-on treatments are the new black. They are provided (most frequently, sold) to patients undergoing in vitro fertilization on the premise that they will improve the chances of having a baby. However, the regulation of add-ons is consistently minimal, meaning that they are introduced into routine practice before they have been shown to improve the live birth rate. Debate on the adequacy of this light-touch approach rages. Defenders argue that demands for a rigorous approval process are paternalistic, as this would delay access to promising treatments. Critics respond that promising treatments may turn out to have adverse effects on patients and their offspring, contradicting the clinician’s responsibility to do no harm. Some add-ons, including earlier versions of preimplantation genetic testing for aneuploidy, might even reduce the live birth rate, raising the prospect of desperate patients paying more to worsen their chances. Informed consent represents a solution in principle, but in practice there is a clear tension between impartial information and direct-to-consumer advertising. Because the effects of a treatment cannot be known until it has been robustly evaluated, we argue that strong evidence should be required before add-ons are introduced to the clinic. In the meantime, there is an imperative to identify methods for communicating the associated risks and uncertainties of add-ons to prospective patients.


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Go to the profile of Fertility and Sterility

Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

3 Comments

Go to the profile of Alexander Quaas
Alexander Quaas 7 months ago

Very interesting discussion on the ethics and regulation of add-ons in IVF. Since the birth of the new field of assisted reproduction, the rapid progress and evolution would not have been possible if every innovation had been subjected to a rigorous approval process - nobody could provide a guarantee that interventions that revolutionized the field (IVF / ICSI / donor egg-based treatments etc etc etc) would be completely "safe" and without harm before doing them. 

So it appears that progress in our field occurs via a combination of adopting promising new interventions while being prudent and following the "do no harm" principle as much as possible. Regarding add-ons, this means being open to adjunct treatments that may actually improve outcomes, while ensuring that no harm to the patient or the unborn baby is done, and while not making false promises.

Therefore the most important paragraph of this article appears to be "Informed consent when effectiveness is questionable". Prescribing androgens or growth hormone to a "poor responder" seems reasonable to me based on the available evidence - see review article on adjuncts in the same issue- as long as the patient is informed that these treatments are "off-label", still under investigation, and not proven to be beneficial beyond a shadow of a doubt (but showing promise in some studies).   

Go to the profile of Micah J Hill
Micah J Hill 7 months ago

I agree with your point Alex.  From my perspective, the problem is that as a field we tend to be very fast adopters. "Add ons" tend to become standards in our clinic, before the evidence supports their wide usage.  And some clinics use add ons as marketing and patient recruiting strategies.  As clinicians, its a challenge to appropriately counsel the individual patient in front of us, when they request these interventions or ask for "anything else that can be done".  As a specialty however, I think we are guilty of broadly adding interventions before the evidence supports their use.  

Go to the profile of Alexander Quaas
Alexander Quaas 7 months ago

Absolutely. The editorial for this “Views and Reviews” section brings up the point that patients may be better off saving resources for multiple cycles, as opposed to spending more money on one cycle if the benefit of the add-on is questionable. Likewise, in an ideal world where resources are distributed more evenly, more patients should get access to “bread and butter” IVF, rather than a few privileged ones doing it with lots of expensive bells and whistles.

On the other hand, an IVF cycle is stressful physically and emotionally, and the dropout rate after one failed cycle is high, so it is worth maximizing success as much as possible (that’s why more research on add-ons is useful). And in certain patient populations, such as poor responders / DOR patients, it is feasible that certain adjuvants may represent the difference between live birth or no pregnancy. 

As you wrote, evidence based counseling is crucial, without preying on a vulnerable patient population.