Fertility Industry Accountability

Industry Oversight

Helping Families Navigate to Accountability

Fertility is a very complex subject that is influenced by several factors, including age, genetics, overall well-being and lifestyle. Dealing with infertility can be emotionally challenging if not exhausting. Innovations in medications, treatments and genetic testing, are being regularly disseminated making fertility treatment decisions confusing, uncertain and downright terrifying. How do we know what information is accurate, false or misleading? We trust our doctors to know the information to help us make well-reasoned decisions through the course of a fertility journey. Doctors must trust pharmaceutical, medical device and genetic laboratory services to provide them with the most accurate and up-to-date scientific information related to their products and services. But what if the doctors are not provided with accurate information? What if doctors are receiving misrepresentations, that they, in turn, provide to patients in guiding them through critical and life-altering decisions? We don’t need to wonder “what if.” We know that it is happening every day.

The fertility industry is a multi billion-dollar industry with little to no regulatory oversight. The industry includes medical clinics that offer a wide variety of treatments and services to aid individuals in conceiving children. These include, for example, assisted reproductive technology (ART) treatments, providing services like in-vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), egg freezing and other assisted reproductive technology methods like genetic testing of embryos prior to transfer in IVF.

Gavel and stethoscope

Based on CDC’s 2021 Fertility Clinic Success Rates Report, approximately 238,126 patients had 413,776 ART cycles performed at 453 reporting clinics in the United States during 2021, resulting in 91,906 live births (deliveries of one or more living infants) and 97,128 live-born infants. Of the 413,776 ART cycles performed in 2021, 167,689 were egg or embryo banking cycles in which all resulting eggs or embryos were frozen for future use. IVF is the most common form of ART and accounts for over 300,000 cycles per year.

Depending upon the state you live in, IVF is not always covered by insurance and can cost couples tens of thousands of dollars, per transfer. On top of those costs are what the industry deems “add-ons.” Treatment add-ons are mostly optional non-essential treatments that may be offered in addition to proven fertility treatment. Most of these add-ons are not covered by insurance and some are being negligently overpromoted by misrepresenting the supporting science, risks and benefits of the treatment. 

Preimplanation Genetic Testing for Aneuploid (PGT-A)

Constable Law is investigating misuse of PGT-A

The goal of PGT-A is to predict which embryos are “euploid,” meaning they have the correct number of chromosomes, and which are “aneuploid,” having the incorrect number, so that by transferring only euploid embryos, a patient has the best chances of getting pregnant, staying pregnant, and delivering a healthy child.

However, the marketing of these tests by the genetic testing companies fails to provide complete and accurate information resulting in far more use of the technology without scientifically established support for the claims they are making, thereby duping many vulnerable want-to-be-parents into spending thousands of dollars on a procedure that is really nothing more than an experiment in guesswork.

PGT-A is not covered by insurance because it is deemed “experimental”, and it is not cheap. The average cost of PGT-A is $5,000 per IVF cycle. That means every dollar goes to the testing of an embryo without the reduction usually taken when insurance helps to cover the cost of medical treatment.

Is the added expense worth it? Not unless you know the true risks and benefits.

Are the genetic laboratories telling us everything? Absolutely not!

What are they leaving out of the PGT-A Conversation?

Biopsying an embryo is not without risk. Embryos are highly sensitive and complex. There is no long-term study ruling out whether such a biopsy harms the embryo in a way that is discovered as one grows into adulthood and beyond.

PGT-A results are not trustworthy. Some studies (conducted by the companies themselves) have demonstrated a higher implantation rate for embryos selected after PGT-A, there is no reliable evidence that it improves your chance of having a baby, let alone a healthy baby.

Some experts believe PGT-A testing may even reduce your chance of having a healthy baby because of the unknown risks of damaging the cells, especially through biopsy and the freezing and thawing process.

PGT-A testing can result in false positives and false negatives. False positives mean healthy embryos are being discarded!

Results vary among laboratories. Laboratories use different technologies and algorithms to perform the test and read the results. This means one lab may find the very same embryo aneuploid, while another finds it “mosaic,” and another may find fine for transfer (euploid). There have been studies showing that certain labs have much higher rates of embryos considered euploid across all age groups. The frightening effect may be having high percentages of euploid embryos discarded.

Arguments in favor of PGT-A use in older patients (older than 35) lack reliable scientific support. Older patients often have very few good embryos and thus very few options. Using a selection tool only takes options off the table. This is especially troubling when we don’t know whether the biopsy damages the embryo short or long term. The risks involved with freezing and thawing an embryo also carries risks that may be even more impactful on the ability for an older patient to have a healthy baby.

PGT-A testing in younger patients (35 and younger) in unnecessary. These patients have such a high proportion of euploid embryos that a test to select good embryos is not necessary and considering the cost and risk it certainly should not be promoted in this age group.

Marketing of PGT-A is false and misleading. Instead of telling doctors and patients these important facts, promotors and marketers of PGT-A claim that PGT-A increases your chances (sometimes as high as 70%) for having a live birth. This is false and misleading. PGT-A doesn’t do anything to improve the quality of embryos. Reliable scientific evidence that it increases the odds overall is sorely lacking to support such claims.

Why are the marketers and promoters of PGT-A spewing false and misleading claims? Duh. Genetic testing, including PGT-A, is tremendously lucrative. That is good news for the hedge funds controlling the genetic labs, bad news for consumers.

The fact that private, for-profit clinics use PGT-A more often than academic medical centers is quite telling. The fact that these hedge funds rake in millions if not billions of dollars at the expense of vulnerable patients who want nothing more than a child, is shameful and should be entirely unacceptable anywhere, never mind in medicine.

If you believe you have been misled, contact Constable Law for a free and confidential consultation.

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