HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--In the latest issue of Fertility and Sterility, a cohort study predicted IVF outcomes using an endometrial biopsy and a biomarker for BCL6 that is highly associated with endometriosis, a leading cause of unexplained infertility (UI). The IRB controlled study statistically concluded that patients with UI are likely to be BCL6 positive and, if left untreated, in a very low prognostic group for success.
The significance of this study supports an on-going trend of IVF centers to use ReceptivaDx™ for testing patients either ahead of the first IVF cycle or after the first failure. The ability to identify and treat these patients earlier in the process reduces costs to the families, reduces the number of transfers required for success and increases the CPR (clinical pregnancy rate) and live births of an IVF center, a major indicator used to assess performance of fertility centers who rely on stronger success rates to attract future patients.
The study was performed over a period of 8 years through the Fertility Center of the Carolinas, a university centered fertility clinic. All women entered the study with a minimum of one year of failed IVF and were tested for BCL6. Seventy five percent of the cohort tested positive and 25% negative. Negative BCL6 results translated to a CPR rate of 75%, consistent with the highest success rates of all IVF patients published by the Society for Reproductive Technology (SART). However, a positive BCL6 result translated to an 18% CPR success rate and an 11% live birth rate putting them in a significantly poorer prognostic group.
Treatment options typically include laparoscopy to remove the endometriosis or hormone therapy to reduce inflammation caused by endometriosis. Both treatments are intended to provide a stable receptive surface for the egg and have a very high success outcome based on centers currently using the test and then treating.
According to Dr. Bruce Lessey, a practicing Reproductive Endocrinologist in Greenville, SC and a co-author of this new clinical data, the suspicion that endometriosis played a role in IVF failure has long been assumed, but rarely followed up with. "Common sense tells us that endometriosis is a major cause of subfertility, but women undergoing IVF are rarely diagnosed with this disease before treatment. This test provides an opportunity for couples to better understand the basis of their infertility and will provide more options and higher success rates."
Lessey further states, "One of the toughest conversations you can have with your patient is why their IVF transfer failed." According to the statistics provided each year by IVF centers, over 100,000 of those "difficult conversations" are taking place each year.
Chris Jackson, CEO of CiceroDx, stated, “Our immediate goal is to provide all women considering IVF access to this highly predictive test. Women and families are spending 10’s of thousands of dollars with the hopes of starting a family. Knowing in advance their BCL6 status will ensure a greater likelihood of success and may reduce the number of cycles needed.”
"There is no other test like this," according to Dr. Aimee Eyvazzadeh, a Harvard educated Reproductive Endocrinologist located in the San Francisco bay area. "The ReceptivaDx™ test has given me the ability to diagnose endometriosis in patients with a simple biopsy. Being able to do this is life changing. Through this test, I'm able to give patients a diagnosis, explanation and most importantly an individualized protocol and path to successful pregnancy."
The ReceptivaDx™ test for unexplained infertility costs $690 with results available in 3 to 5 days. The test is currently offered in over 100 IVF centers across the U.S., Canada, Europe and South America.
For more information, please visit www.ReceptivaDx.com.
CiceroDx is a medical diagnostic company located in Huntington Beach, Calif. ReceptivaDx™ is the company’s first testing panel in the area of unexplained infertility. CiceroDx intends to expand their offering globally and is investing in continued research in the field. For more information, visit http://www.receptivadx.com/about-cicerodx.