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ERA Test Claims to Increase IVF Success. science


For patients undergoing IVF treatment, there is a common test to help determine the best time to transfer the embryo for a successful pregnancy. But one of a growing number of expensive “add-ons” for IVF patients, new research has found, has patients and doctors questioning whether the test is effective for first-time patients.

The test, called endometrial receptivity analysis, takes a biopsy of the lining of the uterus. Next, a lab analyzes the tissue for more than 200 genes to predict the best time to implant the embryo in the womb, according to Igenomix, the manufacturer of the test.

StudyPublished findings in September, they compared live birth rates for first-time IVF patients with ERA to those without, and researchers found no difference between the two groups. In other words, testing in first-time patients does not increase the chances of obtaining a continuing pregnancy, according to the findings.

The research, sponsored by Igenomix and not peer-reviewed or fully published, also noted that more studies are needed to evaluate whether the test would be beneficial for patients who have had multiple failed transfers. The study was led by researchers from Shady Grove Fertility, which has more than 40 clinics in the United States.

The study’s principal investigator and reproductive endocrinologist at Shady Grove, Dr. “This does not improve live birth rates for all women,” said Nicole Doyle. “We had hoped for better results, but it wasn’t worth it for the cost benefit,” he said of the test, which can cost patients up to $1,000.

Columbia University Fertility Center medical and laboratory director Dr. “This kind of study should have been done before,” Eric Forman said. He said the test has been used tens of thousands of times in the United States since it became available in 2011.

Some clinics offer the test for all patients, while others recommend it for failed cycles. Many patients request the test after reading about it on online forums. D., a reproductive endocrinologist in San Ramon, California. Aimee Eyvazzadeh said she offers the test to all patients, and that about half of her first-time patients choose to do it. “When they have the options, they feel very powerful,” he said.

The Shady Grove study offered 767 first-time IVF patients a free ERA prior to transfer. (Genetic testing ruled out any failure with an abnormal embryo.)

One embryo was transferred to each of the patients; half used the test and the other half did not. The results found that just over 54 percent of the group using the test had an ongoing pregnancy compared to just over 63 percent of the control group.

In an emailed statement, Igenomix said that despite funding the research, the company did not have access to the raw data and is waiting for it to be published in a peer-reviewed journal before commenting on the results.

company that is Acquired by Vitrolife july said 25 other studies — 16 internal and nine independent — supported use of tests. In fact, the current body of data shows mixed results about the effectiveness of the test.

A 2018 independent study The percentage of patients who had two or fewer failed transfers found that the test did not improve pregnancy outcomes, but only a small sample of participants was used in the study.

A Igenomix study from 2013 found that one in four women with recurrent IVF failures had a displaced implantation window and concluded that these patients could benefit from using the test. A randomized clinical trial He used a sample of company-sponsored patients from 2020, most of whom were sick for the first time, and some who had made several unsuccessful attempts. The trial concluded that those who used the test had a “significant improvement” in live birth rates, but did not differentiate between first-time patients and previous failed transfers. Some scientists also criticized The methodology of the study is flawed.

The Igenomix statement said that given the latest Shady Grove study, more research is needed to determine whether the test “will be clinically useful in all patients at the first appointment.”

Dr. Highlights the findings of Doyle and his team ongoing concerns of critics About the need for more regulation of the IVF industry. “It is both irresponsible and unethical for clinics to sell scientifically unproven IVF supplements,” said Pamela Mahoney Tsigdinos, patient advocate and author of Silent Sorority.

While the test is approved and regulated by the Centers for Medicare and Medicaid Services, it has not been approved by the Food and Drug Administration. ERA, a lab-developed test, a category that may bypass FDA review, according to Igenomix. (This same space is allowed theranosblood test initiative founded by Elizabeth Holmes, to escape the agency’s oversight. Mrs. Holmes charged with fraud.)

IVF is a costly undertaking with no guarantee of success. According to the data, a single IVF cycle can exceed $20,000. FertilityIQ, a company that provides reviews of fertility clinics. Most people need at least three to four IVF cycles to be successful.

According to preliminary data from the Centers for Disease Control and Prevention, there were approximately 330,000 assisted reproductive technology cycles (including IVF and egg freezing) performed in the United States in 2019, and approximately 78,000 patients gave birth.

New York-based reproductive immunologist and recurrent miscarriage specialist Dr. “IVF has matured as a technology and we are approaching the limits of its effectiveness,” said Andrea Vidali.

He believes add-ons like ERA are the result of an industry focused on “fixing IVF errors”. He said doctors have embraced the test because “when patients ask for a reason why their IVF transfers fail, they don’t want to be told they have unexplained infertility and are looking for answers.”

According to David Sable, a venture capital fund manager and reproductive endocrinologist, patients undergoing IVF are presented with a list of “non-skill” add-ons to assess value.

In light of the new research, some fertility doctors are reconsidering the test’s use on first-time patients, while other doctors are further discouraging from using it.

Founder of Spring Fertility, which has clinics in California, New York, and Vancouver, Dr. “We have always encouraged ERA testing,” said Peter Klatsky. He has observed that the test has grown in popularity in recent years. “This study makes it easy to explain why we don’t recommend this test when patients read positive testimonials online,” he said.

Some patients whose pregnancies continue after using the test are no longer sure whether their success was a result of the test.

Nathalie Carpenter, the 42-year-old founder of a wellness marketing agency and a community advocate for infertility in Connecticut, took the test before two IVF cycles spaced each year. The first resulted in a girl; The second failed. Now he wonders if ERA is effective. But then, “I trusted my doctor; I didn’t question it.”

Some patients are hopeful that, regardless of the uncertain data, the test can scale up towards a successful pregnancy.

Rhian Thomas, a 39-year-old television producer in New York City, prepares for the first embryo transfer at the Columbia University Fertility Center, while the center’s medical and laboratory director, Dr. He told Forman he wanted an ERA. though he was skeptical.

Ms. Thomas, who has experienced multiple miscarriages before, said she wanted to “pass every test on the planet” for the best chance of pregnancy. The transfer after testing resulted in a son who is now seven months old.

Despite the new study, Ms. Thomas said she was glad she had the test and would do it again. “If it doesn’t work, ‘What if the implantation window is closed?’ I was wondering,” he said. “You want control. And that’s what ERA does – it gives an element of control over things.”



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