ERA® Test for Infertility
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assist women who have experienced difficulties with embryo implantation during IVF treatments by studying the timing of the uterus lining's most receptive stage, known as the window of implantation (WOI). Researchers will use the ERA® test to identify this optimal time and the EMMA® test to examine the uterus's microbiome (bacterial environment). Women with previous failed embryo transfers, particularly those with at least one failed attempt using a good-quality embryo, will be suitable candidates. Participants will continue their IVF treatment, and samples will be collected to study these factors, but the test results will not be shared with them or their doctors.
As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant research in IVF advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that no hormone replacement therapy (HRT) should be used in the biopsy and/or embryo transfer cycle, and intrauterine devices (IUDs) should not have been used within 3 months before sample collection.
What prior data suggests that the ERA® test is safe for assessing endometrial receptivity?
Research has shown that the ERA® test, which identifies the optimal time for embryo transfer, is generally safe as it involves no medications. The test examines a small tissue sample from the uterus, similar to a biopsy, a common procedure for collecting tissue for examination.
Studies have found that while the ERA® test does not guarantee higher pregnancy rates, it poses no major safety risks. Most reports focus on its effectiveness rather than safety concerns. As the test is diagnostic and drug-free, it has no serious side effects directly associated with it.
The test has been widely used and is approved for its intended purpose, indicating it is well-tolerated by patients. Participants typically experience only minor discomfort during the biopsy, akin to other standard biopsies.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel approach to understanding implantation failures in assisted reproductive technology (ART). Instead of introducing new drugs, this study uses the ERA® test to analyze the receptivity of the endometrium, which is crucial for successful embryo implantation. By collecting endometrial biopsies and fluid, the trial aims to identify the optimal window for implantation, potentially increasing success rates in patients with previous failures. This focus on personalizing treatment timelines makes it a promising development in reproductive medicine.
What evidence suggests that the ERA® test is effective for determining the window of implantation?
Research has shown that the ERA® test can identify the optimal time for embryo transfer by assessing uterine readiness. In this trial, participants will be divided into two groups based on their ERA® test results: those with a receptive endometrium and those with a non-receptive endometrium. Studies suggest that using ERA® to guide embryo transfers can improve pregnancy chances for some women, particularly those who have previously experienced implantation difficulties. The test pinpoints the best time for placing an embryo in the uterus. However, some experts believe more research is needed to confirm its effectiveness for everyone. Overall, ERA® aims to align embryo transfers with a woman's unique biological timing, potentially increasing the likelihood of a successful pregnancy.12678
Who Is on the Research Team?
Maria Ruiz, MSc
Principal Investigator
Igenomix
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Non-selection Phase
Participants follow their programmed IVF/ICSI treatment, undergo PGT-A testing, and have endometrial samples collected for ERA® and EMMA® tests.
Rescue Phase
For patients not achieving ongoing pregnancy, ERA® results may guide a personalized embryo transfer in a new HRT cycle.
Follow-up
Participants are monitored for clinical outcomes such as pregnancy and live birth rates.
What Are the Treatments Tested in This Trial?
Interventions
- ERA® Test
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Enrolled patients that according to the ERA® report are receptive. The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid. No drugs will be administered as per the study.
Enrolled patients that according to the ERA® report have a displaced WOI and are non-receptive. The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid. No drugs will be administered as per the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Igenomix
Lead Sponsor
Citations
Endometrial Receptivity Analysis (ERA) test: an unproven ...
This article addresses the limitations of the endometrial receptivity array (ERA) methodology to increase implantation.
The study on the clinical efficacy of endometrial receptivity ...
This study aimed to evaluate the clinical efficacy of personalized embryo transfer (pET) guided by ERA in patients with and without RIF.
ERA® Endometrial Receptivity Analysis - Igenomix
ERA® Endometrial Receptivity Analysis evaluates the receptivity of the endometrium to determine if the uterine lining is receptive to embryo implantation.
Endometrial Receptivity Analysis (ERA): data versus opinions
This article summarises and contextualises the accumulated basic and clinical data on the ERA test and addresses specific comments and opinions presented by ...
ERA® Endometrial Receptivity Analysis - IGENOMIX
ERA® is the first diagnostic test that determines each woman's unique personalized embryo transfer timing, therefore synchronizing the embryo transfer with the ...
Endometrial receptivity testing
Endometrial receptivity testing is a test that claims to find the optimal time for an embryo to be transferred into a woman's uterus for the embryo to implant.
Clinical outcomes following endometrial receptivity ...
This study aimed to investigate potential improvements when implementing endometrial receptivity analysis (ERA)-guided personalized embryo transfer (pET)
End of an endometrial receptivity array?
Growing evidence exhibits that ERA-directed embryo transfer does not improve pregnancy rates and may actually be harmful to reproductive ...
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