Investigation launched into IVF embryo bungle

Heartbroken women who may have robbed of the chance to have children say an offer of “free” IVF to replace their lost embryos is “pointless” and that they have “lost all trust” in the world-leading clinic.

Healthy embryos may have been destroyed inadvertently.

A series of high-level investigations have been launched into bungled genetic tests at one of the world’s leading IVF clinics that may have robbed women of their chance to have children.

Federal and state medical authorities have confirmed they are examining Monash IVF over revelations faults its new genetic testing program had resulted in the needless destruction of healthy embryos.

The action comes as women across the country contemplate legal action against the fertility giant after being notified their embryos may have been mistakenly classified as abnormal and discarded due to a faulty non-invasive preimplantation genetic screening test.

Some distressed patients have told the Herald Sun they are unable to produce further embryos and their dreams of motherhood have been shattered. Others are deciding whether to accept Monash IVF’s offer of “free” IVF to replace their lost embryos.

“It is pointless for me to do another cycle as my doctor told me the chance of getting a normal embryo … is less than five per cent,” one woman said.

“I do not want to go through this again as IVF journey is stressful and harmful.”

As revealed by the Herald Sun last Saturday, Monash IVF last week suspended the much-hyped non-invasive genetic testing after a review found it was incorrectly identifying some healthy embryos as abnormal and not suitable for implantation.

A spokesman for Federal Health Minister Greg Hunt confirmed the two federal authorities responsible for approving and regulating the test – the Therapeutic Goods Administration and the National Association of Testing Authorities – have both launched investigations into Monash IVF.

“The Minister is aware of the issue raised and that the TGA and NATA are reviewing this matter,” Mr Hunt’s spokesman said.

Introduced in May 2019, the non-invasive preimplantation genetic screening was intended to detect abnormalities so that only healthy embryos would be used for IVF – at a cost of embryos $495 per embryo.

The Herald Sun understands Victoria’s Health Complaints Commissioner may also examine patient concerns over the Monash IFV test.

Victorian Assisted Reproductive Treatment Authority chief executive officer Louise Johnson said the authority was “deeply concerned” about this matter and gathering information from Monash IVF to understand what had happened.

Ms Johnson encouraged patients to explore their options with Monash IVF and, if they have further concerns, contact the Victorian Health Complaints Commissioner.

“The impact on patients is likely to differ and this issue may be very distressing for some patients,” she said.

“Patient support for those impacted will be crucial, with clear information about what occurred with testing of embryos, including what has happened with any of their embryos tested and what action can be taken from this point on.”

Several women contacted by Monash IVF and informed their embryos may have been needlessly discarded claim they have been offered “free IVF” until they have a viable embryo to make up for the bungle.

Women have discussed having up to 10 embryos which all tested abnormally under the non-invasive Monash test, saying they have been offered free cycles of IVF and counselling until replacement embryos are produced.

Several women stated they are seeking legal advice or contacting health authorities to register complaints in their respective states.

Another said she wanted to be reimbursed for her treatments rather than provided additional cycles promised by Monash IVF.

“I was actually all set to do another round come next month, but after all this personally I have lost all trust in my specialist and the whole clinic itself,” one woman told the Herald Sun.

“I do not see my self carrying on my treatment where I don’t have confidence in the people who will help me have my baby.”

Another who had one of her two embryos discarded after it tested as abnormal said she was offered free cycles until she produced an embryo, however she was now several years older and feared her chances of success had evaporated.

Monash IVF Group Medical Director Professor Luk Rombauts said a review found a “marginal possibility” the cell-free PGT-A test had identified some normal embryos as abnormal, leading to its suspension.

Prof Rombauts said Monash IVF was providing personalised support and assistance based on the individual circumstances of effected patients.

“Monash IVF takes transparency very seriously and as such has notified regulatory bodies about the suspension of the test and is working with them to provide information as required,” Prof Rombauts said.

“It is disappointing for Monash IVF to suspend its cell-free PGT-A testing, as this new screening test was able to successfully identify embryos as chromosomally normal where other tests were not able to.

“We cannot categorically determine which, if any, aneuploid embryos might be suitable and therefore cannot utilise aneuploid embryos for transfer.

“We understand this may be stressful for the small percentage of patients that this affects. We are sorry for any distress involved and we wish to provide these patients with support and assistance.”

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