OPINIONs 003: July 7, 2014
CHR is concerned about the increasing use of the “embryoscope” and similar products from other manufacturers as marketing tools in in vitro fertilization (IVF). Our analysis of published studies so far reveals no outcome benefits from the use of time-lapse photography and closed incubation systems on IVF outcomes. While published data report on identification of significant difference in development speed and other morphological characteristics between embryos, our interpretation of published literature suggests that none of these differences has been statistically associated with outcome benefits in IVF due to embryo selection. Such outcome benefits may still be discovered in the future in association with, to this point, unrecognized morphological features of embryos; however, current knowledge does not support any embryo selection advantages from embryoscopes and similar systems.
Considering the significant expense of each such unit, CHR is concerned about the increasing utilization of such equipment, and about the use of ownership of such equipment as a marketing tool. Recent exaggerations of outcome benefits by reproductive professionals in a CNN special, which characterized availability of such equipment as a “medical breakthrough,” raise serious concerns about the commercialization of embryo selection with unproven and costly new technologies. Moreover, considering the lack of any demonstrated outcome benefits from use of embryoscopes and similar equipment so far, utilization of such equipment should, as of now, be considered experimental, and should only be performed with appropriate informed consents.
CNN’s Chief Medical Correspondent, Sanjay Gupta, MD, himself a practicing neurosurgeon and usually on top of his game in reporting on developments in the medical field, appears to have fallen victim to commercial marketing interests this time, when dedicating a half hour CNN special to an alleged “medical breakthrough” in in vitro fertilization (IVF).
With two experts in reproductive medicine—a young physician from a well-respected Atlanta IVF center (and the wife of one of Dr. Gupta’s partners in neurosurgery practice) and a British biologist with over 30 years of IVF experience—serving as cheerleaders, Dr. Gupta presented the introduction of closed incubation systems with serial monitoring of egg/sperm interaction through fertilization, and serial real-time monitoring of subsequent embryo development via time-lapse photography as a revolutionary step that radically improves IVF outcomes.
Often also called embryoscopy, this few-years-old technique is generally named after the first commercial product brought to market (“embryoscope”). Manufacturers of various similar products, indeed, advertise their systems as “revolutionary tools” for the embryology laboratory, which standardize embryology not only by automating the process of fertilization and embryo culture—otherwise handled by individual embryologists—but also by significantly improving embryo selection, thereby raising IVF pregnancy rates.
But in over two years of aggressive marketing and record sales of these systems to IVF centers all around the world at approximately $100,000 unit costs, not one published study has, yet, been able to demonstrate that any one of these systems really improves IVF outcomes.
This does not mean that published studies did not document and report interesting new observations during fertilization and early embryonic developmental stages; however, while the two cheerleaders in the TV special claimed that use of these instruments “greatly improved” their centers’ IVF pregnancy rates, not a single published study in the medical literature (and there have been quite a number) has, indeed, credibly been able to demonstrate such improvements.
These studies did report significant differences in how embryos develop, first observed utilizing this kind of time-lapse photography. None of these observed differences, however, were associated with significant differences in IVF cycle outcomes and, therefore, could not be used for embryo selection.
All of this, of course, does not mean that continuous research may not, at some point in the future, detect a morphological marker of superior embryo quality after all. But as of this point, time-lapse photography does not offer such a clinical benefit, contrary to what the CNN special report claimed. Time-lapse photography is, therefore, a very interesting research tool but by no means a revolution in clinical IVF. Moreover, at current unit costs, the cost effectiveness of these systems for routine clinical embryology practice in replacing embryology staff positions has to be questioned.
This kind of industry-driven introduction of untested technology to routine IVF practice, unfortunately, is not only restricted to the embryoscope. Indeed, the problems with embryoscopy in many ways resemble what also is happening with another technology that, in recent years, has been alleged to improve embryo selection: Preimplantation genetic screening (PGS). PGS, repeatedly reviewed on our website in recent years and in a number of peer reviewed publications1,2 (see also OPINION 002), has similarly been promoted by commercial interests with totally unsupported claims. Like utilization of the embryoscope as an integral part of routine IVF, PGS was claimed to improve embryo selection and, therefore, IVF pregnancy rates. In both circumstances, our review of the literature suggests that these claims have remained unsupported by data from quite a large number of published studies.
The search for the “perfect” embryo has become the “holy grail” of IVF research. It, therefore, should not surprise and, indeed, should be welcomed that commercial interests see here a potential opportunity.
Both PGS and embryology with time-lapse photography on the surface appear like brilliant ideas. Because of the apparently obvious logic of embryo selection by both techniques, they both received enthusiastic receptions by the IVF community. What in theory looked so promising, however, in practice neither worked in PGS, nor has so far worked with embryoscopes and similar technologies.
The concept of a closed and automated incubation system for eggs, sperm and embryos, which allows time-lapse photography of fertilization and embryo development is very exciting in its hypothetical potential of improving IVF outcomes. It, however, so far has not lived up to practical expectation of IVF outcome improvements.
If good ideas alone could predict results in clinical care, clinical trials would be unnecessary. Like the development of pharmaceuticals by the Pharma industry only allows for the commercialization of a selected few “good ideas,” it would be naïve to expect that every good idea in IVF would automatically become a useful and successful commercial product in clinical practice.
Pharmaceuticals undergo stringent evaluations of efficacy and safety prior to commercial approvals by theFood and Drug Administration (FDA). PGS and embryoscopes (and equivalents), in contrast, are sold by the industry at a considerable cost based on so far unfulfilled promises and with almost no testing of risks.
Most disturbing, while pharmaceutical companies routinely withdraws pharmaceutical compounds that do not meet expectations in early testing rounds, PGS and embryoscope—both new technologies that have repeatedly failed to live up to their promised expectations—continue to be marketed to IVF centers and by IVF centers to the public under the same old promises of efficacy, which studies were unable to confirm.
Such practices further increase the already exorbitant and often unaffordable costs of IVF procedure without any further benefits to patients. Patients should not, unknowingly, have to carry the costs of possibly interesting research projects, and such research should not be performed under the guise of clinical care in the hope that, one day, a clinical benefit for a procedure may, after all, be found. In the meantime, patients very obviously pay for the procedure without any such benefit.
Embryoscopes and similar products, therefore, do not represent “medical breakthroughs,” as recently suggested by CNN. They, indeed, as of now should be considered experimental techniques, which should only be utilized in an experimental study setting and with appropriate informed consents.
- Gleicher N, Barad DH. A review of, and commentary on the ongoing second clinical introduction of preimplantation genetic screening (PGS) to routine IVF practice. J Assist Reprod Genet 2012;29:1159-1166
- Gleicher N, Kushnir VA, Barad DH. Preimplantation genetic screening (PGS) still in search of a clinical application: a systematic review. Reprod Biol Endocrinol 2014;12:22