Unexplained Infertility Is NOT A Final Diagnosis!

Unexplained infertility can be a frustrating diagnosis. Even the simple act of remaining hopeful can become difficult as a result. For those struggling with getting pregnant, the journey can be an emotional roller coaster of fear, hope, elation, frustration, and disappointment. But we are willing to take this journey in the hopes and joy of a new life. A life so fulfilling, it makes the emotional and financial struggle worth it.

For many stuck in the frustration and disappointment phase, we must stay strong, do research, and believe in the process. CiceroDx is here to help find answers for “unexplained infertility.” Let’s start with some relevant facts and the basics for women who (1) have tried unsuccessfully to get pregnant, (2) are considering IVF for the first time, and/or (3) have had failed IVF cycles. Just by reading these facts, you will quickly see you are not alone.

  • In the last 10 years, American birth rates have declined, but the number of babies born through IVF has increased to record levels.
  • Over 6 million women have infertility issues associated with getting pregnant.
  • The average cost of one IVF treatment and cycle is over $12,000.
  • The average number of cycles needed for a successful pregnancy and live birth is between 2 and 3 cycles.
  • Over 30% of women that had three fertility cycles will still not get pregnant.
  • Women who do not get pregnant after failing multiple cycles, fall back into category of “unexplained infertility”. Until recently, this group of women had very few options left to consider.

For patients seeking IVF treatment, it is likely that endometriosis is the cause of unexplained infertility. That fact is not disputed by anyone in the reproductive medical community. Over 50,000 women each year going through IVF are impacted by endometriosis. That might seem high at first glance, but it makes a lot of sense when you consider endometriosis affects over 175 million women worldwide.

Diagnosis of this silent epidemic is often missed. This may be due to a lack of “typical” symptoms and the unavailability of a definitive diagnosis without surgery. In the US, it takes an average of 8-12 years before the diagnosis is achieved. Can you believe that? Women suffering from unexplained infertility might not have any other symptoms of endometriosis other than their infertility. So, what is this disease that is causing all this trouble?

What is endometriosis?
Sometimes tagged as “the most under diagnosed disease of women,” endometriosis occurs when endometrial tissue, which normally lines the uterus, is found elsewhere in the body. This tissue acts just like normal uterine tissue. It builds up and then during menstruation, starts to break down and bleed. As this happens, scar tissue can form in the pelvic region, including in and around the ovaries and fallopian tubes. This can cause a multitude of symptoms, one of which is infertility. The exact cause of endometriosis has not been identified. While interesting from a medical perspective, it does not address your main concern – how can I get diagnosed and will treatment help me get pregnant?

How is endometriosis diagnosed?
Before getting into treatments, we need to understand how the diagnosis of endometriosis is confirmed. Traditionally it is diagnosed with a surgical procedure called laparoscopy, which uses a thin, lighted tube put through a cut (incision) in the belly to look at the endometrium. However, many cases of endometriosis are mild with little to no symptoms such as pelvic pain or painful periods. Often the mild symptoms seem “normal”. For a definitive answer, would you want to have surgery? Now you can see why it has taken so long for many women to be diagnosed.

IVF centers have traditionally stayed away from laparoscopy unless the classical symptoms or history of endometriosis is well defined at the time of the first IVF treatment. This is because the procedure is invasive, expensive, and in most cases unnecessary. But what if you are one of the women who have spent $30,000 or more before a “last ditch” effort to uncover the reason for the unexplained infertility shows endometriosis as the cause?

Now there’s a new test called ReceptivaDx available. This new test can accurately detect endometriosis in any woman regardless of age, ethnic group, or history. An endometrial biopsy is performed (through your OBGYN or infertility doctor). The tissue sample is sent to a lab and reviewed pathologically, using a highly specific protein marker called BCL-6 along with another marker called Beta-3 Integrin used to assess uterine receptivity. The BCL-6 marker has been proven in clinical studies to be highly predictive in detecting even the mildest forms of endometriosis. The results are available in 3-5 days. If positive, a treatment plan can be put into place that significantly increases your chances of a successful pregnancy. The test cost is just under $800.

What kind of treatment is available?
Once diagnosed, hope takes a new turn. Doctors usually consider two treatment options. The first is the laparoscopy. This surgical procedure removes the endometrial scar tissue, making the uterus more receptive to implantation. The other treatment uses a hormone drug like Luprolide™ (Lupron Depot) that works by shrinking the abnormal uterine tissue. As a result, the uterus becomes more receptive and increases the likelihood of carrying your pregnancy to term.

Several conclusions are obvious from this blog regarding the ReceptivaDx test. First, if you have gone through IVF treatments and they were not successful, getting this test done may uncover the underlying cause. If you have tried to get pregnant naturally and have not been successful, having this test done before you begin IVF treatments may help considerably in reducing the number of cycles required for success. If you can’t afford IVF, the test can also be done through your local Ob-Gyn office and sent to the lab. Clinical data and test information can then be sent to your doctor at your request. You can also visit the ReceptivaDx website for a listing of centers currently offering the test near you. Today, IVF centers across the country are ordering the test as part of their fertility workup or after IVF failure. The decision on when to have the test is ultimately up to you, but why take a chance on 2-3 costly IVF failures before asking about the test?

How to get tested with ReceptivaDx?
CiceroDx, the parent company, works with IVF centers and women’s health clinics from all over the US, Puerto Rico and countries around the world. Regardless of your situation, we encourage you to visit the website and learn more about the test, how to order a kit, or to identify a center near you.

Contact CiceroDx customer service at 800-795-5385 or visit www.receptivadx.com to get more information.

Bruce Lessey, M.D., Ph.D. – Scientific Advisor
Lessey’s Corner

The ReceptivaDxTM Test was developed by CiceroDx in conjunction with Pathology Consultants, Inc. of Greenville, SC. Pathology Consultants, Inc. is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). As with other laboratory-developed tests, this testing service has not been cleared or approved by the US FDA or any other federal regulatory agencies. Data have not been submitted to or evaluated by Federal regulatory agencies and the test is not for sale as an In Vitro Diagnostic (IVD) in the US or the EU.


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