Kohesio: discover EU projects in your region

project info
Start date: 1 January 2018
End date: 30 November 2019
funding
Fund: European Regional Development Fund (ERDF)
Total budget: 1 928 692,48 €
EU contribution: 1 012 563,55 € (52,5%)
programme
Programming period: 2014-2020
Managing authority: Nemzetgazdasági Minisztérium
© Dr. Vámosi és Társa Kft (2018)
© Dr. Vámosi és Társa Kft (2018)

Development of prototype vaginal formulation for contraception support

A) Presentation of a summary of the technical content of the grant application. Hungary ranks 23-25th on the basis of population data between the 28 Member States of the European Union. According to moderate experts, the population of Hungary could fall to 7-8 million in half a century. The long-term prognosis of UN statisticians concluded that by 2100 the country might have only 5.2 million inhabitants. In a few decades, the number of women of child-bearing age can indeed be reduced so much in our country that the mere possibility of reproduction of society can be eliminated. Although there has been a family-friendly and significant family support reform in the Hungarian society’s views, the planned/desired children are not born in families. In addition to social and social factors, the growing infertility rate of couples is also reflected in the background of the phenomenon. Worldwide, it can be said that every 6th pair is infertile, and in Hungary, every 5th pair. Between 20 % and 25 % of couples with infertility have no hormonal or organ differences in the background of child deprivation. For these couples, psychological, lifestyle and general health factors may be considered as a cause. Such a factor is the general health of reproductive organs: literature data confirm that often the altered bacterial composition of the vagina (bacterial vaginosis) is behind infertility or repeated miscarriage. Today’s biotechnology toolkit allows us to identify the composition of bacterial communities on the basis of genomic information (without traditional microbiological breeding procedures), with which we can obtain incomparable and more reliable information on composition. The professional knowledge of our cooperating companies and the growth of market demands together underpin the success of a development in which we potentially examine the abnormal bacterial composition of the vagina, which is at the root of childlessness, and develop a probiotic formulation based on our results, which is capable of restoring normal vaginal flora. The prototype will be a vaginal gel product with beneficial bacterial strains and other substances (vitamins and minerals) that support the maintenance of the healthy composition of flora, as well as to include ingredients that support the viability of sperm. On the basis of the prototype, the users of the product to be developed will be couples who are preparing to have children, have difficulties in conception, have multiple miscarriages and are undergoing infertility treatments. A detailed description of the activities to be carried out. Advanced genomic technologies make it possible to examine the vaginal composition at the background of infertility, which is different from normal. Although literary results are already available on compositions, they are purely basic research. As a first step in our development, we present the field of expertise, the research and product development results and patents achieved so far. Due to the novelty of the topic, we do not have enough evidence to determine the composition of the product, therefore we carry out industrial research to identify the bacterial strains to be presented in the product. We cooperate with our clinical partners (SOTE II. Women’s Clinic — Dr. Nándor Ács, St. Margaret Hospital — Dr. Nándor Tűzkő) we collect samples with the help of barren couples waiting for children. After appropriate laboratory pre-processing, the collected biological samples (i.e. pod mucosa scrapers) are subjected to metagenomic sequencing. After this, a bioinformatics analysis identifies which bacterial species were present in each sample and in what quantitative composition. Knowing the proportions in the species, it is possible to identify which differences may pose an increased risk to infertility and which species are “conservative” which are essential for the normal flora. These protective species are produced in industrial quantities and viability tests are carried out in order to be presented in the product. We conduct a literature review to determine the inorganic ingredients of the product and then compile the prototype. Finally, we present the steps and paths of product development from the prototype. We intend to make the novelty in the form of a patent subject to intellectual property protection. C) Presentation of the results obtained. The primary result is the prototype of the vaginal product, which serves to support conception. The product will be presented in such a way that it can be used simply and hygienically on a daily basis. Regular use is recommended for couples who are preparing to have children or who are struggling with failure. It can also be used by women who, although not for conception, seek to restore their vaginal health again

Flag of Hungary  Budapest, Hungary