Periodic Reporting for period 2 - Embryospin (Increasing in vitro fertilization success rate by turning embryo analysis from qualitative to quantitative)
Okres sprawozdawczy: 2022-02-01 do 2023-03-31
Infertility affects one out of six couples worldwide, and more than 25 million people in Europe alone.
In order to realise their legitimate desire to have a baby, infertile couples go through a variety of medical procedures known as Assisted Reproductive Technology (ART). Approximately 2.5 million ART cycles are performed each year worldwide, and Europe is the world leader with almost 50% of all reported treatment cycles. In Vitro Fertilization (IVF), which consists in implanting one or many fertilized eggs (embryos) in the uterus, is one of the most common ART techniques, with more than 1.69 million cycles performed globally every year.
In IVF procedures embryologists currently have to choose the most suitable embryos to implant among a pool of up to a dozen candidates.
Such screening is done through a visual morphological analysis made with a microscope, assessing qualitative information as shape, symmetry and integrity. The problem is that this selection process leads to a frustratingly low success rate: just 33% of women get pregnant after the first cycle, as there is no means for the embryologist to identify the most vital embryos in the pool. Such failure in embryo selection has a huge impact in terms of cost, it increases time to pregnancy and poses a tremendous psychological burden to the couple.
Embryos own a wealth of still unexploited metabolic information, that are fundamental for determining their viability and survival expectancy. However, the means to access such information non-invasively is still elusive. With Embryospin we are developing a solution to make this possible. With a non-invasive test we'll give doctors access to crucial information, from inside the embryo, non-invasively.
In order to realise their legitimate desire to have a baby, infertile couples go through a variety of medical procedures known as Assisted Reproductive Technology (ART). Approximately 2.5 million ART cycles are performed each year worldwide, and Europe is the world leader with almost 50% of all reported treatment cycles. In Vitro Fertilization (IVF), which consists in implanting one or many fertilized eggs (embryos) in the uterus, is one of the most common ART techniques, with more than 1.69 million cycles performed globally every year.
In IVF procedures embryologists currently have to choose the most suitable embryos to implant among a pool of up to a dozen candidates.
Such screening is done through a visual morphological analysis made with a microscope, assessing qualitative information as shape, symmetry and integrity. The problem is that this selection process leads to a frustratingly low success rate: just 33% of women get pregnant after the first cycle, as there is no means for the embryologist to identify the most vital embryos in the pool. Such failure in embryo selection has a huge impact in terms of cost, it increases time to pregnancy and poses a tremendous psychological burden to the couple.
Embryos own a wealth of still unexploited metabolic information, that are fundamental for determining their viability and survival expectancy. However, the means to access such information non-invasively is still elusive. With Embryospin we are developing a solution to make this possible. With a non-invasive test we'll give doctors access to crucial information, from inside the embryo, non-invasively.
Annaida has focused, since the beginning of the project, on the crucial aspects to enable acceptance and adoption of its technology in a clinical setting: safety and effectiveness of the technology.
The team, with the support of expert collaborators, has been able to gather statistically relevant data to show that exposing embryos to a magnetic field does not cause any adverse effects. This has been verified through a broad set of observables including: embryonic development, implantation rates, litter sizes and pup development. This data addresses one of the key safety concerns for the technology.
Further activity has focused on improvements to the sensor technology to enable low-power operation for increased biocompatibility and increased sensitivity for greater accuracy. First studies on bovine embryos have shown, in a model closer to human, the ability to detect relevant biomarkers and to distinguish between different embryo categories. Further biomarker translation has been achieved via tests on different mammalian embryos and ultimately on donated human oocytes. Last but not least, a demonstrator has been completed and is available for demonstrations at Annaida's laboratories.
The results achieved in this project, including the key collaborations setup, have paved the way for the next phases of clinical testing.
The team, with the support of expert collaborators, has been able to gather statistically relevant data to show that exposing embryos to a magnetic field does not cause any adverse effects. This has been verified through a broad set of observables including: embryonic development, implantation rates, litter sizes and pup development. This data addresses one of the key safety concerns for the technology.
Further activity has focused on improvements to the sensor technology to enable low-power operation for increased biocompatibility and increased sensitivity for greater accuracy. First studies on bovine embryos have shown, in a model closer to human, the ability to detect relevant biomarkers and to distinguish between different embryo categories. Further biomarker translation has been achieved via tests on different mammalian embryos and ultimately on donated human oocytes. Last but not least, a demonstrator has been completed and is available for demonstrations at Annaida's laboratories.
The results achieved in this project, including the key collaborations setup, have paved the way for the next phases of clinical testing.
The Embryospin device developed by Annaida is the most sensitive magnetic resonance device for non-invasive microscopic chemical analysis. It has paved the way for unprecedented applications in microbiology and, the focus of this project, fertility. The project will further progress in safety validation and will produce the first data of its kind from human samples. Furthermore, partnerships with key stakeholders will position Annaida to the next phase, clinical trials.