Clinical Trial Announcement:

Unexplained infertility may get new answers and treatment plans thanks to The University of Western Australia clinical trial, in partnership with Amelia Bio

• An emerging factor in unexplained infertility and adverse pregnancy outcomes is the presence of an asymptomatic infection caused by bacterial species known as Genital Mycoplasmas.
• Now, a WA phase 2 clinical trial run by The University of Western Australia with support of Australian women’s health start up Amelia Bio, will investigate a new treatment plan involving an antibiotic followed by a new Australian vaginal probiotic pessary.
• Approximately 15% of couples worldwide face difficulties conceiving after at least 12 months of trying.

Over 200 couples will partake in the ‘RESETTER’ study, which aims to reduce the rate of unexplained infertility in couples attending Concept Fertility and City Fertility who test positive for Genital Mycoplasmas.

Both partners will be treated with antibiotics, with the female partner using Amelia’s V-Spot probiotic, a Lactobacillus dominant pessary, containing vaginally active probiotic strains, for five weeks post-antibiotic treatment. The natural conception rate in treated couples will be documented in the three months following treatment and compared with this in couples who were negative for Genital Mycoplasmas.

Principal Research Fellow at University of Western Australia, Obstetrics and Gynaecology Matthew Payne said, “A unique feature of the RESETTER Study is that it considers the couple as a single unit when it comes to antimicrobial/probiotic treatment. We know that many genital bacteria are trafficked back and forth between partners and as such a single partner treatment strategy, as is commonplace in many other clinical scenarios, is unlikely to succeed in the long term.”

Catherine Slogrove, director of Amelia Bio, said it was pleasing to see the vaginal microbiome become more of a focus in fertility research.

“There’s so much we don’t have answers for when it comes to the microbiome and infertility. We know the emotional impact of unexplained infertility for couples who want children is often heart-breaking and severe. We are delighted to support clinical research that has the potential to be life-changing for so many couples, and it’s incredible that an Australian institution, is leading the charge globally,” she said.

In addition to standard health assessments, fertility specialists today conduct more in-depth investigations to identify the root cause of infertility, rather than simply categorizing it as ‘unexplained.’

So far, only two clinical trials have explored the treatment of Genital Mycoplasmas in male partners, demonstrating highly significant improvements in sperm parameters. These studies also indicate a notable increase in successful pregnancies following treatment.

The study will run through to the end of 2026.

ENDS

MEDIA CONTACT

Ellen Hahn
Papaya PR
0414674743
ellen@papayapr.com.au