Mitochondrial Donation: An 18 Month Outcome Study.
This study is checking on the health and development of children conceived using a special IVF technique called mitochondrial donation. Researchers will follow these children from before birth up until they are 18 months old. They will use a recognised test to see if the children are developing normally for their age, looking at things like their movement, thinking skills, and communication. The main goal is to understand if children born through mitochondrial donation grow up just as healthy as other children, focusing on their brain and overall development. This information will help doctors and families understand the long-term effects of this new fertility treatment.
At a glance
What is this study about?
This study is all about understanding how children conceived using a special IVF technique called 'Mitochondrial Donation' (sometimes shortened to MD) grow and develop. Mitochondrial donation is a new way to help families have a baby free from certain genetic illnesses called mitochondrial diseases. These diseases can be very serious, affecting many parts of the body. When a baby is conceived this way, most of their genetic material comes from their parents, but a tiny amount comes from a donor, specifically the healthy mitochondria which are like the powerhouses of our cells.
Researchers want to carefully observe these children from when they are in the womb right up until they are 18 months old. They will use a well-known and respected test called the Bayley-III to check on the children's development. This test looks at various aspects, such as how they move, how they understand and use language, and how they interact with the world around them. By doing this, the researchers hope to confirm that children born using mitochondrial donation develop normally, both in their brains and overall.
The main question this study aims to answer is whether children born after mitochondrial donation develop in the same healthy way as other children by the time they are 18 months old. The results from this study are really important because they will help doctors and families make informed decisions about this treatment and give us a clearer picture of the health and well-being of these children in their early years.
Key takeaways
- The study observes development of children born using mitochondrial donation.
- It checks physical and mental milestones up to 18 months of age.
- No new treatments or medications are given as part of the study.
- Participation helps understand the long-term effects of this new fertility treatment.
- You must agree to join before starting mitochondrial donation treatment.
- You can stop participating at any time.
Who may be eligible?
You might be able to join this study if you are a woman who is planning to have or has had treatment using mitochondrial donation. This treatment is offered to women who have a confirmed genetic change (mutation) related to mitochondrial disease.
To be eligible, you must be suitable for mitochondrial donation treatment as approved by the HFEA (the UK's fertility regulator). You'll also need to agree to take part in the study *before* your mitochondrial donation treatment starts. It's important that you and your doctor believe you can attend all the necessary check-ups and appointments.
You won't be able to join the study if you've decided not to have mitochondrial donation treatment, or if you're unable to attend the planned appointments or share information from your pregnancy and your child's first 18 months. The study is open to women of any age, and only women can take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman with a confirmed mitochondrial DNA genetic change?
- Are you suitable for mitochondrial donation treatment as approved by the HFEA?
- Are you willing to give your informed consent for the study before your treatment starts?
- Are you able and willing to attend appointments for yourself and your baby until they are 18 months old?
What does participation involve?
If you decide to take part, the study will involve collecting information about your pregnancy, your baby's birth, and their development until they are 18 months old. The key part will be an expert assessment of your child when they are 18 months old (adjusting for how early or late they were born if needed). This assessment will use a special test called the Bayley-III, which looks at how your child is growing in different areas like movement, thinking, and communication. There are no medications involved in the study itself, as it's purely about observing and recording development. You would need to be willing to share information collected throughout this period, from pregnancy to your child's 18-month check-up.
Potential risks and benefits
Locations (1)
- The Newcastle upon Tyne Hospitals NHS Foundation TrustVerified postcodeNewcastle upon Tyne, United Kingdom· Recruiting
Common questions
What is 'Mitochondrial Donation'?
It's a special IVF technique for women with certain genetic conditions to have a baby free from serious mitochondrial diseases. It involves using healthy mitochondria from a donor.
What will researchers be looking at in my child?
They'll observe your child's overall development, including things like their movement, understanding, and communication skills, up to 18 months of age.
Does my child have to take any medication for this study?
No, this study doesn't involve any medication. It's purely about observing and recording your child's natural growth and development.
How long will my family be involved in the study?
You'll be involved from before your mitochondrial donation treatment begins until your child reaches 18 months old.
What happens if I change my mind about participating?
You have the right to withdraw from the study at any time without having to give a reason, and it won't affect your or your child's medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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