Fecundis HyperSperm technology increases the number and quality of embryos produced through in vitro fertilisation

The biotech start-up Fecundis, based at the University of Barcelona Parc Científic de Barcelona (PCB-UB), is taking a new step forward in innovation in assisted reproduction. The results of a clinical trial involving 41 in vitro fertilisation (IVF) patients, carried out in Argentina by the Fecundis scientific team in collaboration with researchers affiliated with the National Council for Scientific and Technical Research (CONICET), reveal that the use of HyperSperm technology, developed by this Barcelona-based company, increases not only the number of viable embryos but also their quality.

The study, published in the Journal of Translational Medicine, shows that HyperSperm increased blastocyst development by 16% compared with the conventional procedure. Furthermore, the rate of usable blastocysts – embryos of sufficient quality to be transferred or cryopreserved – increased by 22%, thereby expanding the clinical options available within a single in vitro fertilisation cycle. In the subgroup of embryos analysed using PGT-A – a genetic test for the detection of aneuploidy – a higher proportion of euploid (chromosomally normal) embryos was observed in the group that used HyperSperm compared with the control group.

Since 2022, clinical trials involving HyperSperm have led to the birth of 11 healthy babies, all without any abnormalities reported; the most recent birth took place just two months ago, and further pregnancies are currently under way.

Traditionally, assisted reproduction has focused on the oocyte, the embryo and the uterus. Sperm, on the other hand, has almost always been assessed on the basis of three basic parameters: how many there are, how many are moving, and what shape they are. These are useful figures, but they don’t tell the whole story. What they do not measure is whether the sperm is actually capable of successfully fertilising the egg and contributing to the healthy development of the embryo. Now, HyperSperm technology demonstrates that improving sperm preparation prior to fertilisation directly results in more high-quality embryos per cycle.

In this context, every viable blastocyst counts. A greater number of embryos with implantation potential broadens the range of transfer options within a single cycle and can significantly alter the patient’s clinical journey.

According to Matías Gómez Elías, R&D Manager and COO at Fecundis: “This study demonstrates that influencing sperm capacitation can have a direct impact on embryonic development and reinforces the role of the sperm as a key factor in early embryo quality.”

HyperSperm: a new way of preparing sperm for fertilisation

From an innovation perspective, Fecundis is introducing a significant shift in approach to assisted reproduction. Whilst most sperm preparation technologies compete to select the best sperm, HyperSperm proposes moving from selection to the functional optimisation of sperm. Before fertilising an oocyte, the sperm travels through the female reproductive tract, where it undergoes a series of biochemical and functional changes known as sperm capacitation. This process gives them the actual ability to fertilise. However, the conventional methods of sperm preparation used in IVF treatments select motile sperm, but do not replicate the dynamic environment of the female body, meaning that many sperm may reach the insemination stage without having been properly capacitated. This limitation is particularly significant in a context where, on average, only one in three embryo transfers following IVF results in a pregnancy.

HyperSperm tackles this very challenge. This is a sequential laboratory kit that recreates the key stages of capacitation, incorporating the biochemical and physical signals necessary for the sperm to reach a functional state closer to the physiological one prior to fertilisation.

In the clinical trial, which involved 41 couples at three Argentine clinics – Pregna, Fertya and In Vitro Buenos Aires – each patient’s eggs were divided into two groups: one inseminated with conventionally prepared sperm and the other with sperm prepared using HyperSperm. As each patient acts as their own control, the design reduces the impact of individual differences and strengthens the robustness of the comparison.

One of the most significant findings of the study shows that HyperSperm not only increased the number of blastocysts obtained, but also the proportion of embryos with a normal chromosome set, a promising result that will need to be confirmed in larger studies.

Of particular note is the fact that, in some treatment cycles where the conventional method failed to produce any viable blastocysts, the use of HyperSperm resulted in at least one transferable embryo.

For anyone undergoing in vitro fertilisation, going from having no embryos at all to having an option for embryo transfer is not just a statistic – it is a new opportunity. “In assisted reproduction, every embryo counts. Unfortunately, many patients remain at the threshold of motherhood because they do not have normal embryos. Our results indicate that HyperSperm will help these women have a real opportunity to move closer to their dream of becoming mothers,” said Arina Rogozina, CEO of Fecundis.

The technology can also be integrated into the standard workflows of any laboratory without any significant changes to clinical procedures, which facilitates its adoption.

A strategic milestone for a growing company

For Fecundis, the publication of this new study marks a strategic milestone, as it consolidates the scientific basis of HyperSperm and reinforces the company’s position as a biotechnology firm focused on developing reproductive solutions based on advanced sperm biology and sperm capacitation. In a field where innovation has traditionally focused on the embryo and the oocyte, Fecundis has adopted a different approach: to optimise sperm function as a means of improving the effectiveness of in vitro fertilisation treatments.

Following the publication of these new clinical results, Fecundis is currently in the process of raising funds to accelerate the next development milestones for HyperSperm. The funding will enable the company to make progress along the regulatory path set out for the United States and Latin America, prepare for entry into the US market and consolidate the company’s position as a leader in innovation based on sperm biology. At the same time, it has developed a veterinary product range aimed at the animal reproduction market, where sperm optimisation has a direct economic impact on the livestock industry. This line of research opens up a path for technological expansion beyond human reproductive medicine and reinforces the potential of Fecundis’s technology in various fields of assisted reproduction.

With this roadmap, Fecundis aims to establish HyperSperm as a benchmark tool in IVF laboratories worldwide and to demonstrate that advanced sperm biology can become one of the sector’s new drivers of innovation.

Image: In the front row, Arina Rogozina, CEO, and Matías Gómez, Director of Operations, together with the Fecundis team. Photo / PCB-UB