Recent research suggests that a popular test that tens of thousands of women have done in the hopes of improving their chances of getting pregnant during IVF treatments is likely not worth the pain or expense for most patients.
"We tried for a long time to get pregnant on our own," Caroline Godfrey, a resident of Ashburn, Virginia, said.
Godfrey’s journey to motherhood was a long one.
"We did different diets. We added things to our diets, took things out of our diets. We tried supplements. … We bought all of the over-the-counter tests. We did timing and apps and all that stuff, and it's very consuming. It consumes your whole psyche. Everything you're thinking about is, 'Can we get pregnant?'" Godfrey said.
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In 2018, Godfrey went to Shady Grove Fertility, hoping the D.C. area’s largest fertility clinic could help her and her husband Andrew expand their family.
But after a couple unsuccessful embryo transfers, she tried another option, enrolling in a clinical trial designed to test whether there’s an optimal time for transferring an embryo, and whether that differs for each person.
"The idea of a test that could give you that information was really enticing, like, the perfect time to get pregnant," Godfrey said.
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More than 750 women took part in the trial, undergoing an endometrial receptivity analysis, or ERA, test. During the test, doctors take a biopsy of the endometrial lining of a woman’s uterus and the sample is then analyzed to predict the best time for transferring an embryo.
The test is painful and costs up to $1,000. Doctors say it's not covered by insurance.
Shady Grove Research Director Dr. Kate Devine said the findings of the clinical study, published in the Journal of the American Medical Association, show the test isn't worth it.
"We all very much hoped that this was going to be a test that would help women achieve their goal of family more efficiently, and, unfortunately, we did not find that. But it's good news still in that we are able to help patients avoid cost, time, discomfort," Devine said.
Godfrey had an ERA test done as part of the study, but what she didn’t know was that she was part of the control group, meaning that the information doctors collected from her test wasn’t used to calculate the perfect timing for her transfer.
But she got pregnant anyway. Her son Henry is now almost 4 years old.
"The data showed that the addition of an ERA did not increase the rate of live birth compared to a standard embryo transfer," Dr. Nicole Doyle said.
Doyle said families going through artificial reproductive technology want to try anything they can, but trials like this can help physicians guide patients to the right decisions.
"Sometimes, you know, it's not about adding on all these tests that are costly, invasive and time consuming. Sometimes it's just a matter of trying again, you know, pick yourself up and trying again. So I just push them through the next transfer and after three, the majority of them are successful," she said.
Godfrey now has a third baby on the way. She hopes her story will help others looking for answers.
"It's isolating, you know. You don't know how to find the best information, who has the best information. Having a study like this where someone can say, we did the study, we looked at all these results, this really does help you or really does not help you, is reassuring," she said.
The ERA test is one of many expensive add-ons patients can do during the IVF process and not all of the tests out there have been through rigorous and robust validation.
ERA has been available in the U.S. since 2011.
In a statement, Igenomix, the makers of the ERA test, responded:
"Since 2011, more than 200,000 women worldwide have undergone the ERA test by Igenomix. Many women have benefited from the ERA results and knowing the best time to transfer an embryo based on their unique genetics. Dedicated to helping women, our research at Igenomix has not only positioned us as the experts in women’s reproductive health but has led us to pioneer tests that provide a 360° view of endometrial health.
"Personalized treatment, grounded in genetics, is the future of all medicine. The ERA test is a prime example of personalized medicine at its best. The ERA test has proven results, with over 20 clinical studies worldwide supporting its use and hundreds of thousands of commercial cases received from more than 4000 clinics and over 90 countries. The ERA test was introduced as a solution for women suffering from repeated failed embryo transfers. When applying the ERA test to this target population, the chances of having a baby can be significantly increased.
"With only a 25-30% live birth rate per started IVF cycle, health care professionals need to do better for their patients. Leveraging genetics and personalized medicine to push for a better standard is necessary. We should challenge the notion of “just try again” and prevent burdening patients with failed transfer after failed transfer, wasted embryo after wasted embryo, as we have the technology available to optimize this process for them. Our goal at Igenomix is a healthy baby at home, and we are committed to making this a reality for our patients sooner rather than later."