An EU-funded project implemented in Hungary has conducted clinical research to develop a prototype of a probiotic vaginal gel that could help with conception. It is targeted primarily at couples who have no medically diagnosed cause of infertility, but who are nonetheless struggling to conceive.
Probiotic vaginal gel to help couples conceive developed in Hungary
- 15 January 2020
Users of the product will be couples who have difficulties conceiving, have had multiple miscarriages, or are undergoing infertility treatment.
The gel is formulated with bacterial strains that combat and suppress bacterial vaginosis and with ingredients such as vitamins and minerals that increase the chances of conception and a healthy pregnancy by supporting beneficial vaginal flora and the survival and viability of sperm.
With regular application of the gel – which is a simple and natural treatment with no harmful side effects – the normal composition of vaginal flora can be restored, thereby eliminating a barrier to getting pregnant.
Rising levels of infertility
Infertility rates are on the increase, with 1 in 6 couples worldwide thought to be unable to conceive, rising to 1 in 5 in Hungary. Moreover, Hungary’s population has been declining since 1980, when it was over 10.7 million. By 2011, it had fallen below 10 million and it stands at under 9.8 million today.
Approximately 20 % to 25 % of infertile couples have no hormonal or organ dysfunctions or abnormalities that could explain their situation. For these couples, psychological, lifestyle or general health factors may be having a negative impact on their reproductive organs.
A possible link between bacterial vaginosis, which entails changes in the bacterial composition of the vagina, and infertility or repeated miscarriages is well documented in medical literature. However, availability of probiotic vaginal conception support preparations is currently extremely limited.
Precise identification of bacteria
During the project’s research and development phase, the main challenge was to pinpoint the bacterial abnormalities in the vaginal flora of infertile women and explore the differences between them and women able to conceive.
In relation to this, two critical problems had to be solved: the first was the availability of appropriate biological samples; the second was the precise identification of the microbiome – the genetic material of the microorganisms – in the samples.
It was thus necessary to collect biological specimens, which could only be done in a clinical setting with the cooperation of gynaecologists. Also, the degree of precision required meant that the research could not be performed solely with conventional microbial culturing methods, which involve allowing organisms to reproduce under laboratory conditions.
Instead, the bacterial flora composition of the vagina was investigated using metagenomic sequencing. This method is superior to conventional culturing. It allows researchers to test all genes in all organisms in a sample and accurately gauge bacterial diversity and quantify the different species present.
Based on the findings, allied to data from existing scientific literature, it was possible to develop a special probiotic composition capable of restoring and maintaining normal vaginal flora and thus facilitating conception.
Total investment and EU funding
Total investment for the project “Development of a conception supportive vaginal gel prototype” is EUR 2 000 000 (HUF 682 240 000), with the EU’s European Regional Development Fund contributing EUR 1 400 000 (HUF 477 541 000) through the “Competitive Central-Hungary” Operational Programme for the 2014-2020 programming period. The investment falls under the priority “Research and innovation”.