By analyzing Messenger RNA using the RT-qPCR technique, the team led by Dr. Nathalie Lédée and Marie Petitbarat have identified biomarkers that can be used to propose personalized treatment to increase birth rates for women with failed embryo implantation or who have suffered several unexplained miscarriages.
A summary of the results of clinical trials conducted since 2012 was published on July 11th in the International Journal of Molecular Sciences, and confirms the increased live birth rate and drastic reduction in miscarriages following MatriceLab testing and personalized treatment recommendations.
This immunological test of the endometrium has been patented as a technique to enhance implantation success in assisted fertilization (PCT/EP2013/065355). The expression of each biomarker is normalized to the average expression of reference genes, enabling an immune profile to be identified for each patient. Thanks to this profile, personalized management can be proposed to improve uterine receptivity and maximize the chances of successful implantation.
Dr. Nathalie Lédée is convinced: “Personalized reproductive medicine must take into account the uterine side of the equation, so as to be able to build customized treatments based on each patient’s characteristics. Innovation in personalized medicine at the heart of ART pathways is crucial, as it can increase success rates while reducing the risks and costs (financial, but also psychological and human) associated with ineffective or unnecessary interventions.”
From early cohort studies to clinical trials
From 2012 to 2018, patients’ endometrial immune profiles were analyzed, and deregulation was found in 81.7% and 82.8% of patients in the first and second cohorts, respectively.
In the first cohort, immune overactivation was diagnosed in 56.6% of cases, while underactivation was observed in 25%. In the second cohort study, overactivation was diagnosed in 57% of cases, while underactivation was observed in 25%.
The rate of live births at the time of first embryo transfer in deregulated and subsequently treated patients was significantly higher (39.8% and 38.4% in the first and second cohorts, respectively), compared to patients without deregulation, for whom no treatment could be proposed, and whose live birth rate was significantly lower (19.4% and 26.9%).
All prospective cohort studies confirm the importance of endometrial immune assessment in increasing birth rates!
In controlled cohort studies, 193 patients with multiple implantation failures underwent endometrial immune assessment, and personalized treatments were administered to those diagnosed with immune dysregulation. These patients were compared with a control group of 193 patients who did not undergo endometrial immune profiling.
The corresponding live birth rate was significantly higher than in the control group (30.5% vs. 16.6%, OR: 2.2 [1.27-3.83], p = 0.004), with a simultaneous drastic reduction in miscarriages per initiated pregnancy (17.9% vs. 43.2%, OR: 0.29 [0.12-0.71], p = 0.005). The 22% of patients without dysregulation did not differ from their matched controls in terms of live birth rate and miscarriage.
For Marie Petitbarat, Managing Director of MatriceLab, “clinical studies, both completed and ongoing, suggest that this approach can increase live birth rates and reduce the time it takes to go through the ART process to have a child. It’s time to stop blindly prescribing immune modulators, and focus instead on immunological analysis of the endometrium, in order to propose personalized and adapted treatments”.
The ESHRE (European Society of Human Reproduction and Embryology) is moving in this direction in its latest recommendations, moving uterine immunological testing into the category of tests that may be of interest in an ART program.