This week, one of Australia’s biggest IVF providers announced its second embryo mix-up in as many months.

In a statement to the ASX on Tuesday, Monash IVF confirmed it’s investigating a recent “transfer incident” at one of its Victorian clinics.

Two days later, its CEO and Managing Director, Michael Knaap, resigned.

It comes after the provider revealed in April that a woman gave birth to a stranger's baby after an embryo mix-up in one of its Queensland clinics.

The latest Monash incident has raised broader concerns about Australia’s assisted fertility industry, prompting Health Minister Mark Butler to discuss the sector with his state counterparts.

Today, we’ll take a closer look at the Monash IVF incidents and explain what you need to know about the industry, how it’s regulated, and the calls for change.

In Vitro Fertilisation or ‘IVF’ is Australia’s most commonly used form of assisted reproductive technology.

Around 20,000 babies are born through IVF here every year.

According to the Australian and New Zealand Assisted Reproduction Database (ANZARD), that figure represents 1 in 18 children, and “1 in 10 children born to mothers aged 35 years and older.”

With offices in over 100 locations nationally, Monash IVF Group describes itself as “the pioneers of IVF in Australia”. The company says it’s delivered 50,000-plus babies, and that it continues “to lead the future of fertility advancements.”

Monash IVF made headlines in April after a patient gave birth to a stranger's baby.

Here’s what happened.

A woman undergoing IVF treatment through Monash’s Brisbane clinic was implanted with an embryo (a fertilised egg) that belonged to another couple doing IVF through the same clinic.

The transfer was successful, and the woman gave birth to a baby that was not biologically hers before any error was detected, Monash IVF revealed earlier this year.

The company’s Brisbane clinic was only made aware of the incident in February, after the couple who had the baby requested to transfer their remaining embryos to another IVF provider.

When the clinic went to action the transfer, it realised it was storing an unexplained extra embryo for the couple.

An investigation later confirmed that an embryo from a different couple had “been incorrectly thawed” and transferred to the birth parents, resulting in the birth of a child. It’s not clear how old the child was when the mistake was discovered.

In a statement, Monash IVF blamed the incident on “human error” and said an independent investigation and a full review of its lab processes were underway.

At the time, Monash IVF CEO Michael Knaap said he was confident this was “an isolated incident”.

Earlier this week, the company announced a second embryo transfer mix-up.

During a transfer procedure at one of its Melbourne clinics, a patient received an incorrect transfer of their own embryo. According to Monash IVF, the patient was supposed to receive their partner’s embryo.

“Monash IVF has extended its sincere apologies to the affected couple, and we continue to support them,” it said.

Monash IVF Group’s CEO/Managing Director has resigned in the wake of this latest embryo transfer incident.

In an ASX statement on Thursday, the company’s board said it “acknowledges and accepts” Michael Knaap’s decision to stand down.

“Since his appointment in 2019, Michael has led the organisation through a period of significant growth and transformation, and we thank him for his years of dedicated service,” it said.

Following news of Knaap’s resignation, Monash IVF’s share price rose by more than 8%.

However, the embryo mix-ups have seen the company’s stock market value plummet by roughly 50% this year.

The Monash IVF mix-ups have led to renewed concern about how assisted fertility is regulated and what safeguards are in place to protect patients and babies.

At present, each state and territory has its own set of IVF rules. The Fertility Society of Australia and New Zealand (FSANZ) warns this has created inconsistencies across “important issues” like “how many families a donor can help create, how long embryos can be stored, and whether surrogacy is legal and accessible.”

FSANZ – the peak industry body for reproductive medicine – is calling for national reforms to streamline regulatory gaps that it says “significantly impact children, parents, donors, and the cost of [IVF].”

A 2024 review of the fertility sector by FSANZ recommended urgent federal legislation and a 10-Year Fertility Roadmap to address these inconsistencies.

FSANZ is also pushing for a new independent authority, known as the Reproductive Technology Accreditation Committee, to strengthen “oversight and trust” across the sector.

Since it handed down its review in September, the peak body says both federal and state governments are yet to commit to significant reform.

“The trust patients place in our profession is sacred, and we must continually earn it through clear governance, shared responsibility, and action,” FSANZ said in a statement this week.

“The recent incidents at Monash IVF highlight the complexity and sensitivity of assisted reproductive technology [and] demand full transparency, rigorous investigation, and a sector-wide commitment to learning and improvement.”

Federal Health Minister Mark Butler said he would address concerns about the sector in a meeting with his state counterparts this week.

Ahead of talks on Friday, Butler said that since IVF “started in state hospitals,” it has “traditionally been regulated by state governments.” However, he acknowledged IVF is now “overwhelmingly a private sector enterprise, largely funded by families themselves and private health insurance, along with Medicare and PBS funding from the Federal Government.”

Speaking to the ABC, Butler said there is a clear case for national consistency, “at the very least, but I'll say to states, if there's a role that they think the Commonwealth can play, I'm open to that.”

“Clearly, something needs to be done here,” he added.

Following Friday’s meeting, the Department of Health announced a “rapid review” into the IVF sector, to “identify opportunities for improvement and action.”

The three-month evaluation will bring together state health department analyses of current regulatory and accreditation processes. It will also look into establishing an independent accreditation body, in line with FSANZ recommendations.

Finally, the rapid review will consider “whether a national regulatory approach would deliver benefit.”

Following the meeting, Victorian Health Minister Mary-Anne Thomas welcomed the review, saying “we’ve got work to do,” but that she was “pleased with the outcome”.

Butler said as a father of “an IVF baby,” he appreciates “the level of trust that families place in the sector to deliver them what feels like, at the time, a miracle baby.”

The review is due to be completed by mid-September.

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