Two Argentine researchers, who have been working for 15 years on the study of the intestinal microbiota, have developed a diagnostic kit that allows the design of personalized treatments to reduce treatment time in pregnant people with fertility problems. Since 2020, it has been marketed in Argentina and Spain, and in April of this year it arrived in the United States.
The development belongs to the molecular biologist Gabriela Gutiérrez and the biochemist Agustina Azpiroz, who in 2019 founded Microgénesis, a biotechnology startup focused on the study of the human microbiota to restore the chances of pregnancy.
The microbiota, define the researchers, is a set of living microorganisms or bacteria that are found in the digestive system and the genital system from the birth of people. Its functions are, among others, to protect against pathogenic bacteria that can cause diseases, maintain the immune system, regulate metabolism and energy balance, food digestion and vitamin production, details the study.
However, he continues: “When there is an alteration of the microbiota and there is an imbalance between the different bacterial strains, one of the possible effects is infertility, a pathology that affects more than 60 million people worldwide”.
The research originated in the classrooms of the University of Buenos Aires (UBA). Azpiroz, a native of Tandil, was specializing in reproductive microbiology within the framework of her doctorate in Medical Sciences, under the direction of Gutiérrez, a Conicet researcher specializing in reproductive immunology.
They began to investigate intestinal inflammation. “It was known that there was a link with infertility and so we dedicated ourselves to studying where this inflammation came from. We discovered that it was from the intestinal microbiota,” Gutiérrez tells ClarÃn. The molecular biologist details: “30% of women with infertility have not detected the cause. But 8 out of 10 women of that 30% with ‘unexplained infertility’ have intestinal inflammation.”
“In general, all women who are undergoing fertility treatments follow special diets or take probiotics. The problem is that until now there was no nutritional guide to personalize the diet and the use of supplements. A woman perhaps reads that Peruvian maca it’s good and she starts to consume it, but maybe it’s not what she needs”, continues Gutiérrez.
What the test they developed achieves is to provide information about the microorganisms that are missing from the person’s microbiota. In this way, a personalized treatment plan can be generated. “You may even have to avoid the use of certain supplements, because you have a certain microorganism in excess,” says the researcher.
The test consists of a vaginal swab and was designed to be self-administered and “it is easier to insert than a tampon,” compares Gutiérrez. The person who buys the test, after collecting the sample, sends it by mail to the start-up and in 15 days will have the results.
The second part of development is treatment. “Each patient has access to the Microgénesis portal, where she can access a diet plan, supplements, probiotics and physical exercises according to the test result”, she describes. And she adds that once a month the person will be able to have a virtual consultation with a professional who provides follow-up and emotional support.
The first testing of the test kit and the treatment plan was carried out in Argentina and Spain on 287 women who had been trying to get pregnant for ten years and had an average of four rounds of in vitro fertilization without results. In less than six months, 129 became pregnant, 30% spontaneously and the rest through fertilization processes such as in vitro. The average success was 75%.
In the world, it is estimated that around 15% of couples have fertility problems. Taking the data from the last census on couples of reproductive age, it would be a million links.
One of the main challenges is the cost of IVF. “It is estimated that only one infertile woman in ten can afford the cost of treatment and that in general three rounds of fertilizations are needed for the embryo to take root,” explains Gutiérrez.
He is excited to think that the kit will democratize access to fertility treatments in a non-invasive way: “It can be done from anywhere and because it either makes it possible to dispense with in vitro fertilization or decreases the number of rounds necessary for the person to get pregnant “.
The next step, he dreams, will be to obtain funds to continue working so that the test is reimbursable by health insurance, he advances. Today, the kit costs about $400 in the United States.
For the creators of Microgénesis, the test could be applied in the future as a cheaper and self-administered tool for the diagnosis of intestinal inflammation, beyond fertility problems.
“When a microorganism of the intestinal microbiota is missing, the immune system of the intestinal barrier responds by generating these markers, which are capable of traveling from the intestine to any part of the organism: it impacts the ovary, in the endometrium, which is where the embryo is implanted , in the thyroid, in the vaginal microbiota”, explains the molecular biologist.
All this has an impact at the reproductive level. “But fertility problems are also a symptom that something is not right. Intestinal inflammation can lead to hypothyroidism, polycystic ovaries, insulin resistance, endometriosis and ovarian failure,” she warns.
In the short term, says the researcher, Microgénesis plans to develop a test to diagnose and treat men, and to study fertility problems in couples.
