Advancement in assisted reproductive technology: Mitochondrial donation

Overview

Mitochondrial donation is an evolving assisted reproductive technique (ART) which may assist women to avoid transmitting mitochondrial disease to their child.[1]

There is no cure for mitochondrial disease, which is a group of rare genetic disorders that affect the mitochondria of human cells, and can cause muscle weakness, fatigue, heart problems, seizures and developmental delays. It can lead to premature death of children, debilitating pain, long-term ill-health and poor quality of life. It affects one in 5,000 people. At least one child is born in Australia with severe mitochondrial disease each week.[2] However, this evolving ART-based procedure envisages hope for preventing faulty mitochondrial DNA from being passed to a child. A clinical trial will soon be underway to gather evidence for mitochondrial donation efficacy, in accordance with the conditions imposed by the passing of the Mitochondrial Donation Law Reform (Maeve’s Law) Act 2021, which permits mitochondrial donation in Australia.[3]

How does it work?

The procedure for mitochondrial donation involves extraction of the nuclear DNA from the egg of the prospective mother (that contains the faulty mitochondria), and inserting it into a healthy donor egg which has previously had its nuclear DNA removed. Sperm (from the prospective father) is then added to the donor egg which now contains the mother’s nuclear DNA (minus the mitochondrial features) for fertilisation. The technique facilitates the parents’ genes being transmitted to the child;[4] however, the child will also possess a genetic code from the donor of the donor egg, although the donor’s traits will not be expressed in the child’s characteristics. Ultimately, this technique minimises the risk of the mother transmitting mitochondrial disease to the child whilst allowing the parents’ genetic information to be retained and transmitted.

Fertility experts in the United Kingdom pioneered the mitochondrial donation technique and it was the first country to approve this technology in  2015[5]. A recently published report (July 2025) notes that eight babies have successfully been born through this procedure and all are developing normally, without mitochondrial disease.[6]

The Law

The Mitochondrial Donation Law Reform (Maeve’s Law) Act 2021 took effect on 1 October 2022. This permits mitochondrial donation in Australia, but only in a research and clinical trial setting, with strict regulatory conditions. The conditions include  laboratory-based research and clinical trials of the technique. The Australian Government will fund (up to $15 million over four years) a clinical trial at one selected clinic to evaluate the safety and effectiveness of this evolving ART.[7] Clinics must possess a licence to perform the procedure under Maeve’s law.[8] A Monash University-led project team was selected in March 2023 to conduct the pilot program (named ‘mitoHOPE’)  to determine the feasibility of implementing mitochondrial donation in clinical practice.

The clinical trial of mitochondrial donation technique by mitoHOPE is estimated to commence in mid-2026, although this timeline is currently subject to regulatory approvals.[9]

Controversy and Concerns

Mitochondrial donation raises social and ethical concerns. The procedure arguably involves a ‘three-parent’ baby, thereby impacting the identity of the child. Whilst a child will have DNA from three individuals, the child will not be affected by the donated mitochondrial DNA; the child’s characteristics and traits will be determined solely by the parents’ nuclear DNA.[10] Nonetheless, Maeve’s law requires a Mitochondrial Donation Donor Register to be maintained to keep a record of information about children born as a result of the technique and their mitochondrial donors. The register is intended to allow a  child to apply to access the donor’s information when they turn 18 years old.[11]

The implication of mitochondrial donation on the definitions of genetic modification, and potential creation of ‘designer babies’ is a further concern.[12] There have been debates about whether the creation of such embryos would have unforeseeable and irreversible consequences on future generations.[13] Strict regulation of the deployment of this technique is intended to address these concerns, but with rapid technological advancement in clinical practice, such questions will continue to pose challenges which will remain difficult to  resolve.

Sources

• Australian Government Department of Health, Disability and Ageing – Mitochondrial donation (20 May 2025): https://www.health.gov.au/our-work/mitochondrial-donation?language=en
• Monash Biomedicine Discovery Institute – What is mitochondrial donation? And how might it help people have a healthy baby one day? (8 July 2024): https://www.monash.edu/discovery-institute/news-and-events/news/2024-articles/what-is-mitochondrial-donation-and-how-might-it-help-people-have-a-healthy-baby-one-day
• mitoFoundation – Mitochondrial Donation: https://www.mito.org.au/mitochondrial-donation/
• NHMRC – Mitochondrial Donation licensing Scheme: https://www.nhmrc.gov.au/research-policy/embryo-research-licensing/mitochondrial-donation/mitochondrial-donation-licensing-scheme
• NHMRC – Mitochondrial donation: https://www.nhmrc.gov.au/research-policy/embryo-research-licensing/mitochondrial-donation
• Australian Genomics – Mitochondrial donation now legal in Australia: https://www.australiangenomics.org.au/mitochondrial-donation-now-legal-in-australia/
• ABC News, ‘Eight babies have been born via  a new IVF technique called mitochondrial donation. What is it?’ (17 July 2025): https://www.abc.net.au/news/2025-07-17/mitochondria-disease-ivf-monash-university/105541348
• Scimex, ‘Expert Reaction and Media Briefing: First babies born in the UK through mitochondrial donation’ (17 July 2025): https://www.scimex.org/newsfeed/expert-reaction-first-babies-born-in-the-uk-through-mitochondrial-donation#:~:text=Eight%20children%20in%20the%20UK,passed%20Maeve's%20Law%20in%202022
• ‘Social and ethical issues in mitochondrial donation’, British Medical Bulletin, Volume 115, Issue 1, September 2015, Pages 173–182, https://doi.org/10.1093/bmb/ldv037: https://academic.oup.com/bmb/article/115/1/173/260760