Monash IVF Group Limited announced via the ASX that an incident occurred at its Clayton laboratory on 5 June, where a patient’s own embryo was mistakenly transferred instead of their partner’s, contrary to the treatment plan.

Monash IVF has apologised to the couple involved and is providing ongoing support. The incident has been reported to the Reproductive Technology Accreditation Committee (RTAC), a subcommittee of FSANZ and the Victorian Health Regulator. An internal investigation is underway, and the scope of the existing independent review has been expanded to include this most recent incident.

“Our thoughts are with the family directly affected by this event. Although the embryo transferred was the patient’s own, we acknowledge the emotional toll this has taken and extend our heartfelt sympathies to those involved,” said Dr Petra Wale, FSANZ President.

The recent incidents at Monash IVF highlight the complexity and sensitivity of assisted reproductive technology (ART). The embryologists and healthcare professionals involved are highly trained and committed to helping people build families.

“Over the years, these professionals have enabled thousands of successful pregnancies and brought immense joy to many.

“While these incidents are deeply difficult for those affected, they are exceedingly rare and must be taken seriously, without losing sight of the overwhelming positive contributions made by the sector” Dr Wale said.

Australia’s fertility care system is among the safest, most transparent, and tightly regulated in the world. FSANZ acknowledges the responsibility providers carry and the trust placed in them by patients. System and safeguards are continually reviewed to ensure lessons are learned, and standards strengthened.

Following notification to RTAC and the Victorian Health Regulator, Monash IVF has extended the existing independent investigation to look at this latest incident and is taking steps to prevent future incidents.

Due to the sensitive nature of these events, and the impact on families and staff, FSANZ will be making no further comment.

“We ask the community and media to respect the privacy of those involved as they work through this complex, personal situation.”

Call for national reform in fertility regulation

While clinical standards in IVF clinics are nationally consistent, legislation governing fertility treatment varies widely across Australia. Each state and territory set its own rules on important issues – like how many families a donor can help create, how long embryos can be stored, and whether surrogacy is legal and accessible.

As the peak body responsible for setting national standards in ART across Australia and New Zealand, FSANZ continues to call on Australian Federal and State Governments to commit to a nationally consistent framework and establishing RTAC as an independent statutory authority to strengthen oversight and trust.

This recommendation outlined in our 10-Year Fertility Roadmap, released last year, aims to improve oversight, public trust, and sector accountability.

Transitioning RTAC to an independent statutory authority will strengthen the accreditation scheme with the regulatory clarity and operational flexibility needed to uphold rigorous standards and respond swiftly to emerging risks.

A national approach to ART would strengthen transparency, streamline governance, and enhance patient care across the country. It would also support better data collection, benchmarking, and sector-wide continuous improvement.

“FSANZ remains committed to working with all levels of government to implement a nationally consistent approach to ART - ensuring safer, fairer, and more responsive fertility care for all Australians,” Dr Wale says.

ENDS

For media enquiries, please contact:

Annette Stenhouse: annette.stenhouse@londonagency.com.au, 0416 861 732
Rebecca Dawson: rebecca.dawson@londonagency.com.au, 0435 948 116