The best time to transfer the embryo for a successful pregnancy is determined by a common test. New research has patients and doctors questioning whether the test is effective for first-time patients.
The test takes a sample of the interior lining of the uterus. Igenomix says the test can predict the best time to place the embryo in the uterus by analyzing the tissue for more than 200 genes.
Researchers found no difference between the two groups when it came to live birthrates for first-time I.V.F. patients who had the E.R.A. According to the findings, the test does not improve chances of getting pregnant in first-time patients.
More studies are needed to assess whether the test can be beneficial for patients who have had multiple failed transfers, according to research sponsored by Igenomix. The study was led by researchers from a fertility clinic.
The study doesn't improve the live birthrates for all women, according to the lead researcher. She said that the test is not worth it because of the cost benefit.
The medical and laboratory director at Columbia University's Fertility Center said that the study should have been done earlier. He said the test had been used tens of thousands of times in the US.
Some clinics offer the test for all patients, while others recommend it for those with failed cycles. Many patients request the test after reading about it in online forums. Half of the first-time patients in San Ramon, Calif., chose to have the test, according to Dr. Eyvazzadeh. She said that they feel so confident by having the option.
767 first-time I.V.F. patients were offered a free E.R.A. before transfer. There were no failures involving an abnormal embryo.
Half of the patients used the test and the other half did not. The results showed that 54 percent of the group that used the test had an ongoing pregnancy, compared with 63 percent of the control group.
Igenomix said in an email that despite funding the research, the company had not had access to the raw data and was waiting for it to be published in a peer-reviewed journal.
The company said that 25 other studies supported use of the test. The data shows mixed results about the test.
The test did not improve pregnancy outcomes in a study of patients with two or fewer failed transfers.
One Igenomix study found that one in four women with repeated I.V.F. failure could benefit from using the test. A randomized clinical trial sponsored by the company from 2020 used a sample of mostly first-time patients, with some who had experienced up to a few failed attempts. The trial concluded that those who used the test had a significant improvement in live birthrates, but did not differentiate between first-time patients and those with previous failed transfers. The study's methodology has been criticized by some scientists.
Igenomix said that more research was needed to determine if the test could be useful in all patients at the first appointment.
Critics have been concerned about the need for greater regulation of the I.V.F. industry. Adding-ons that are scientifically proven are unethical for clinics to sell.
The test is regulated by the Centers for Medicare and Medicaid Services, but not by the FDA. The E.R.A. is considered a laboratory-developed test by Igenomix. The loophole allowed Theranos, the start-up founded by Elizabeth Holmes, to avoid the agency's oversight. Ms.Holmes is on trial.
I.V.F. is not guaranteed to succeed. According to data from FertilityIQ, a single I.V.F. cycle can go over $20,000. People need at least three to four cycles to be successful.
According to preliminary data from the Centers for Disease Control and Prevention, there were almost 330,000 assisted reproductive technology cycles performed in the United States in 2019.
I.V.F. has reached maturity as a technology and we are approaching the limits of its efficacy, according to Dr.
The E.R.A. is a result of an industry focused on I.V.F. failure. He said that the test was adopted because patients don't want to be told they have unexplained infertility when they ask for a reason as to why their I.V.F. transfer failed.
Patients undergoing I.V.F. are presented with a list of add-ons with no ability to assess the value, according to David Sable, a venture capital fund manager and reproductive endocrinologist.
Some fertility doctors are reconsidering the test's use on first-time patients, while other doctors are discouraged from using it at all, because of the new research.
The founder of Spring Fertility said that they have always discouraged the E.R.A. test. The test's popularity has grown in recent years. He said that the study makes it easier to explain why we don't recommend the test.
Some patients who used the test are unsure if their pregnancies were a result of the test.
The founder of a marketing agency and a community advocate for infertility in Connecticut received a test ahead of two I.V.F. cycles. The first resulted in a child and the second did not. She wonders if the E.R.A. was effective. At the time, she said she trusted her doctor.
Regardless of the ambiguous data, some patients are still hopeful that the test could tip the scale toward a successful pregnancy.
Rhian Thomas, a television producer in New York, told Dr. Forman that she wanted an E.R.A.
Ms. Thomas said she wanted to go through every test on the planet in order to have a baby. A son was born after the transfer after the test.
Ms. Thomas said she would do it again despite the new study. She wondered if the window for the implant would be off if it didn't work out. You want control. The E.R.A. gives control over these things.
