ICSI Research IVF Science

3 July 2023

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Melbourne IVF’s clinical trial shows a 10% boost to developing ICSI embryos

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New hope for IVF couples with male infertility problems

Australian research has found an embryo culture medium containing antioxidants increased fertilisation rates by 10% for patients undergoing intracytoplasmic sperm injection insemination (ICSI), in a clinical trial led by Melbourne IVF researchers.

The randomised controlled trial (RCT) led by Melbourne IVF’s Scientific Director Professor David Gardner, found that adding antioxidants to IVF culture media improved fertilisation rates for ICSI patients from 58% to 68%. The study results are being presented at the European Society of Human Reproduction and Embryology (ESHRE) annual meeting in Copenhagen, on 28 June, 2023.

The results of this three-year clinical trial are very exciting and immensely encouraging for couples with male related infertility; particularly as 50% of infertility cases that we see are due to ‘male factor’.

- Professor David Gardner

Professor David Gardner, Virtus Health's Group Director of ART, Scientific Innovation & Research said, “As a direct result of the higher fertilisation rates after ICSI, we saw an overall increase in blastocysts available for either transfer or cryopreservation (freeze) in the antioxidant group.

“We saw a significant difference; in the antioxidant group there were 3.1 blastocysts, compared to 2.7 in the control group,” said Professor Gardner.

Professor Gardner explains why antioxidants are important for developing embryos and how the antioxidant media was developed: “Antioxidants are molecules that protect cells and tissues from damage created by reactive oxygen species (ROS).

“Over the past seven years, studies in my lab at the University of Melbourne found that the addition of antioxidants to mouse oocytes, sperm and embryo media have benefits for embryo development and fetal growth,” said Professor Gardner.

Melbourne IVF, a member of Virtus Health, was the first clinic in the world to do a prospective randomised control trial.

“On the basis of the comprehensive evidence from mouse models in the lab, a clinical trial at Melbourne IVF was developed to determine if antioxidants in media could also benefit human embryos,” said Professor Gardner.

This Australian-first RCT enrolled 1,482 patients between Jan 2019 – Nov 2021. The trial involved half of the recruited patients receiving standard IVF media for egg and sperm collection, insemination and embryo culture. The other half of the patients received the same media but with the addition of three antioxidants: acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA).

Running a randomised control trial with nearly 1,500 patients was a huge undertaking. It shows how serious Virtus Health is about research.

- Professor David Gardner

“It wasn’t the easiest trial to do, recruiting patients during a world-wide pandemic. The exciting results fire our commitment to further trials.

Dr Rebecca Kelley, Scientist at Melbourne IVF, who is presenting the research data at ESHRE, said: 

“The aim of this research was to compare and assess IVF outcomes in standard culture media versus culture media supplemented with antioxidants. This combination of antioxidants was developed in Professor Gardner’s lab at the University of Melbourne, where they conducted the basic research to demonstrate its benefits for gametes and embryos. The next step was to test the efficacy of these antioxidants in clinical IVF by doing a randomised controlled trial.”

Professor Gardner said: “A Randomised Controlled Trial is the definitive evaluation for any new technology. It’s the only appropriate way to ensure its efficacy for our patients."

The antioxidant culture media is now being rolled out across Virtus Health clinics, including IVFAustralia, Queensland Fertility Group, and TasIVF, giving increased hope for IVF couples with male infertility problems.

Professor Gardner says, "This study reflects the commitment of Melbourne IVF and Virtus Health to furthering patient care through active clinical research. As well as the efforts we make every day for every patient – we are always looking to see what we can do tomorrow for every patient in the future."

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