Improving gamete quality to increase IVF outcomes

Description:

 

Market Need

Infertility affects one in five couples; with 40% of cases directly attributable to male factors, 40% attributable to female factors and the remainder due to fertility problems in both partners, or unknown causes.

 

Most fertility treatments and technologies currently in clinical use focus on treating women, or treating their oocytes or embryos in vitro, in order to achieve pregnancies.  Yet, success rates remain low with only ~20% of initiated ART cycles resulting in a live birth. Further, as a significant proportion of couples are unable to conceive due to reduced male fertility, there is an unmet clinical and market need to target the male partner of the couple. 

 

 

The Technology

Our researchers have identified a small molecule insulin sensitiser known as BGP-15, that when used to treat sperm has a positive impact on mitochondrial activity and improves embryo development following IVF.

 

The studies focused on treating ‘middle-aged’ mice as a sub-population, as this represents a growing patient population seeking treatment for infertility.

 

These mouse studies demonstrated that treating sperm cells of the older males with BGP-15  for 1 hour prior to fertilization  improved sperm motility and led to much better embryo development following in vitro fertilization.  Similar beneficial results have been observed when human sperm is treated with BGP-15.

 

 

BGP-15 treatment improves sperm quality and embryo development. Sperm motility was increased when sperm from older male mice was treated with BGP-15 (left). BGP-15 treated sperm used in IVF gave rise to significantly improved blastocyst development rates (right, photo of example embryo). Data are mean ± SEM; N=12 Young mice, N=12 Older mice; paired t-test.

 

 

This technology offers the potential to develop a suite of products to treat human gametes to increase successful outcomes during IVF processes.  We also understand that treatment of the gamete prior to fertilisation, rather than treatment of an embryo, offers a more streamlined regulatory pathway for product approval.

 

 

Research Team

The research has been led by Professor Rebecca Robker, a researcher at the University of Adelaide and member of the Robinson Research Institute.  Professor Robker has an in-depth understanding of gamete biology and has over 10 years’ experience examining the impact of BGP-15, primarily on oocytes, with her team’s more recent work developing applications for sperm.

 

 

IP Position

A provisional patent titled ‘Methods and Products for improving sperm quality’ was filed in September 2017 and has since progressed to PCT.  This patent is a method of use patent covering the impact of BGP 15 on sperm development.

There is no composition of matter patent over the molecule, so we have freedom to operate with BGP-15.

 

 

Clinical development

We have established a number of small scale collaborations with Australian IVF clinics, to access human gamete samples.  In late 2017 the University granted the research team a small commercialisation grant to support this work.

 

 

BGP-15 treatment improves human sperm quality. Human sperm (washed in preparation for clinical IVF) was untreated or treated with BGP-15 for 30 minutes. BGP-15 treatment increased motility (% of motile sperm; N=30 men) and decreased sperm DNA damage; both oxidation (N=27 men) and fragmentation (N=21 men). Data are mean ± SEM. Statistical analysis was paired Student’s T-test.

 

Over 2018, we have acquired proof-of-concept data in human sperm samples, validating the effect of BGP-15 on sperm quality, and providing critical insights into the biological function of BGP-15 on sperm.  The outcome of these experiments will enable us to develop a more detailed clinical translation pathway, including identifying and engaging with international clinical trial partners for the next phase of development.

 

In parallel to this human work, the research team has grant funding to support additional mouse studies, to generate data on the impact of BGP-15 on live birth outcomes.  In addition, academic and industry collaborations are being investigated to extend these studies into larger animal models, to validate the potential to commercialise this product in the animal IVF industry.

 

We are currently negotiating our ongoing relationship with an experienced manufacturer of BGP-15, to secure supply of the compound for future studies, as well as develop a regulatory strategy to support the approval of a product including BGP 15 for clinical use in human IVF processes.

 

Funding sources for a large scale human clinical trial, and completion of the large animal studies are being fully investigated by the research team. There are strong possibilities for commercialization in both the human and animal IVF industries.

Patent Information:
Category(s):
Biology
Therapeutic
For Information, Contact:
Kirsten Bernhardt
The University of Adelaide
kirsten.bernhardt@adelaide.edu.au
Inventors:
Rebecca Robker
Macarena Bermudez-Gonzalez
Keywords: