IVF is a gamble.
Every year, more Australians desperate to have a baby put all their hopes — and sometimes all their savings — into IVF.
Most who sign up for it say it's worth the risk.
But a new genetic test that was supposed to decrease that risk has left patients furious with the Monash IVF Group, and feeling robbed of their chance to have a genetically related child.
'I feel duped'
Danielle Bopping was 39, single, and acutely aware that time was running out for her dream.
"I always wanted to be a mum. I've worked with children and families for 25 years. I just wanted to have my turn, and I felt like I had lots of love and time and energy to put into a small person, that's my small person," she says.
Ms Bopping bought donor sperm from the US and asked Monash IVF to help her conceive.
In 2019, Monash IVF launched a new genetic test, to determine which embryos were best for implantation — which had the best chance of becoming a baby.
At the launch of this new test, the Monash IVF Group's Medical Director said it had long been the industry's holy grail.
The standard test, used in Australia since the 90s, involves taking a biopsy from the embryo, which can destroy the embryo in the process.
But this new test was non-invasive. It involved taking DNA from the liquid surrounding the embryo, in which it had been growing, in the lab.
Ms Bopping said this new test was spruiked as cheaper, with almost the same accuracy rate as the riskier biopsy method.
"I definitely remember a conversation [with the specialist] around … the new test is financially a better option, and it's OK to go with that because it is just as effective," she says.
Ms Bopping had this test done on her last embryo — this, she felt, was her last chance at a baby. And the results came back saying it was non-viable.
"In IVF circles we always talk about, 'It just takes one [embryo]. It only takes one. All you need is one.' And that was my one…
"It's the grief about having to let go of potentially ever becoming a mother, having to let go of not being able to give my mum a grandchild."
But in October 2020, when Ms Bopping was a year into grief counselling, she got a letter from Monash IVF saying its new test wasn't as accurate as she'd been told. Her embryo might have been viable after all.
She'd long since given it away, donated to scientific research. Now Monash IVF was telling her it would pay for another round of treatment.
"Immediately, I was like, 'Oh, this stinks. There's something not right here. You haven't necessarily admitted fault, yet you're offering me, kind of, $10,000 to have a whole free cycle?'
"For me, it was disbelief. How can this happen? A year down the track, how can you come back to me and say that actually that embryo may have been viable?
The chance to have another cycle didn't mean much to her. By this stage, she was 42, so her chances of success had decreased substantially.
"For some women, that would have been great, but as someone who was already in their 40s when they started the process … that didn't really seem like a great recompense."
The company now says Ms Bopping's embryo is still in storage, but years down the track, and with further risks introduced each time an embryo is thawed for a test, she's not inclined to try her luck again.
'We had faith in the system'
Ms Bopping wasn't alone: 1,300 patients were given the test, and more than half of them were told their embryos were non-viable.
Monash IVF Group admitted in a revised fact sheet that the test was only giving the same result as the standard test 75 to 85 per cent of the time.
Women who wanted to take up the chance of a free round of IVF were asked to sign a waiver that suggested there was approximately a 50 per cent chance that their original test result was incorrect.
Michelle and Damien Pedersen had reached out to the Monash IVF Group's Darwin-based clinic, Repromed, in 2020.
Ms Pedersen doesn't remember a choice between the standard genetic test and the new one.
"We had complete and utter faith in the medical system and trusted clinicians' advice because they've been to uni for 10 to 12 years doing this. Who am I to question what their recommendation is?"
The new test deemed four of Ms Pedersen's embryos viable, two non-viable, and one inconclusive. None of her four viable embryos were successful, and she donated the other three to research.
The couple were also offered a free cycle by the Monash IVF Group.
But they've now been approved to adopt a child from South Korea.
"There's heaps of kids in the world that need a mum and dad," says Mr Pedersen.
International adoption is the subject of intense debate over ethics, and it can be fraught and expensive. The couple acknowledge it's not for everyone.
Ms Pedersen says this is a path they mightn't have taken, had the genetic test been more reliable.
"There's a bit of grief in terms of that they won't be my blood. But I was happy to accept that because I would rather do that than have no child at all."
The class action
Michelle Pedersen and Danielle Bopping are now the lead plaintiffs in a class action against the Monash IVF Group, and its subsidiaries, Monash IVF and Repromed.
Lawyer Michel Margalit is running the class action.
She hopes to mediate before the end of this year and she claims compensation could run into tens of millions of dollars.
The Monash IVF Group suspended its new genetic test in October 2020, shortly after it realised the test was finding higher than expected numbers of embryos to be non-viable for implantation.
But Ms Margalit says the company should have seen red flags from the start.
She applied under Freedom Of Information (FOI) provisions for documents regarding any investigations undertaken by the regulator — the Therapeutic Goods Administration — into the Monash IVF Group's new test.
One of the documents is a letter from the Monash IVF Group subsidiary, Repromed, to the testing accreditation body, the National Association of Testing Authorities.
The document describes how the clinical trial data was reviewed by the Monash IVF Group when the problems started to come to light.
What the review found was disturbing.
In the original clinical trial done by the Monash IVF Group, some samples had been counted numerous times, and other samples were left out of the findings altogether.
"A group of embryos were intentionally kept out of the study, even though they were tested as part of the study. And had they been counted, it would have made the result overall less accurate," says Ms Margalit.
"I'm sure that a scientist looking at it would say, this is a complete joke."
Repromed itself even raises the possibility that the data was left out on purpose:
"It is unclear why these samples have not been included and it could be interpreted that they may have been deliberately omitted from the validation summary table."
— Letter from Repromed to NATA, 21/10/20
The scientist who designed and ran the clinical trial has since passed away, so we may never know why the data was handled this way.
'Poor science'
Background Briefing asked retired embryo geneticist Leeanda Wilton about the FOI documents. She helped introduce the standard genetic test (biopsy testing) to Australia and has done countless clinical trials.
Dr Wilton is worried that the clinical trial wasn't done as a blind test. A blind test is one where the researcher knows nothing about the samples they're testing. But in the Monash IVF Group's clinical trial, researchers studied the results of the new test in conjunction with results from the standard test. Ms Wilton says this could have introduced unconscious bias.
"I'm not suggesting it's necessarily deliberate, but it's very easy to be persuaded into interpreting the fluid result to match what you've seen in the cell results. Good science blinds the samples."
Dr Wilton says this study design, combined with the overcounting and exclusion of samples, draws into question the validity of the study.
"The non-blinding is probably poor study design and poor science. The matters of the samples, I don't know what actually happened, but I find it very difficult to come up with some explanation for how that could have happened."
Best practice suggests that studies like this should be peer reviewed before a test like this is used in a clinical setting, but this is not a requirement.
The Monash IVF Group's study was not peer reviewed.
Dr Wilton speculates that maybe it was because they thought they had a world-first, and didn't want to be pipped at the post.
"But you can be too secretive, you know?
"It's about the betterment for everyone."
'Occasionally this happens'
Representatives of the Monash IVF Group declined to be interviewed by Background Briefing, but said in a statement:
At all times Monash IVF has acted in the best interests of patients. It noticed an unexpected trend in the outcome of IVF cycles in June 2020 as part of routine monitoring. At this point, Monash IVF had no reason to suspect any fault in its new genetic test, but it started a review. When preliminary findings suggested further review may be warranted, Monash IVF suspended the test.
In documents filed with the court as part of its defence, the Monash IVF Group says the reason the new test was recommended for Michelle Pedersen and Danielle Bopping was because their embryos were not suitable for the standard test, which could damage the embryos. But both women say they weren't told this when they were offered the new test.
Repromed's medical director, Professor Kelton Tremellen, gave an interview to ABC Adelaide last year, in which he said he'd like to turn back time.
"Unfortunately the test has not worked out to be as accurate as we'd hoped … I would love to turn back the clock, but unfortunately this is the situation we've faced.
"When you're a company who tries to innovate to bring best quality new technology to your patients, unfortunately occasionally this happens. We unreservedly apologise for this."
Professor Tremellen said even with further developments, he can't see a time when offering this test will ever be possible for his team.
"It's over, unfortunately."
The science is 'not quite there yet'
The idea of a non-invasive genetic test, this holy grail, often crops up at medical conferences.
One insider told the ABC it's always talked about as "the next big thing", but the general consensus is that the science is not ready for clinical use.
"If you look at the whole body of scientific literature around this, published scientific journal articles, every article says it is not there yet," says lawyer Michel Margalit.
The Monash IVF Group disputes the suggestion that it was acting against the consensus of scientific literature available at the time, and that its clinical trial was not enough to support taking its new test to market.
As recently as last week, a Berlin conference on pre-implantation genetics heard that this type of non-invasive test was still not ready for clinical use.
The conference heard from international scientists who've been researching this test.
One attendee, Tony Gordon from Cooper Genomics, summarised on his LinkedIn page: "The tech is improving but the opinion of the room seemed to be it's not ready for patient testing."
'I want to see them held to account'
Ms Pedersen says there needs to be more regulation within some corners of the IVF market.
"To make sure that people are provided what's best for them — not what's best for the business, not what's best to get more patients through the door — and less of the six-minute medicine."
Two of Australia's biggest IVF providers are listed on the stock exchange. Monash IVF Group is one of them. Ms Pedersen fears too much focus might now be on shareholders, instead of patient care.
She wants to sound the alarm to others considering IVF. And she says she wants Repromed held to account.
"These are medical professionals, you rely on their expertise. We knew that it wasn't always going to work, but we just wanted to feel that they've done their best for us. And that's where we feel like they fell down."
Whatever the outcome of the class action, Ms Bopping says a price can't be put on patients' trauma.
"They potentially robbed me of that opportunity [to have a genetically related child].
"Many women now have lost the opportunity for those embryos to become children."
