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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Persons encountering health services in circumstances related to reproduction
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Assisted Reproductive Technologies (ART) such as IVF treatment usually result in multiple embryos of variable quality. The best embryo is selected for replacement in the womb and couples are given the option to freeze any remaining good quality embryos. The options available for eggs (with its surrounding cells), sperm and embryos that are not used for treatment are that they are discarded or donated to research. Those who agree to participate in this research would be donating such eggs, sperm or embryos to research.
We also plan to recruit healthy volunteers to donate eggs, their surrounding cells and sperm for laboratory study including the creation of embryos. Some experiments will involve collaboration with other centres within and outside the UK and samples may be sent to these centres for further approved studies. As required under legislation, all the research that is proposed has been approved by the Human Fertilisation and Embryology Authority.
The studies that will be carried in the laboratory are closely interrelated but have distinct aims i.e. improving treatments for infertility and debilitating diseases and understanding early developmental events in the egg and embryo. Information obtained from our proposed investigations can inform more than one aim. Previous REC consideration agreed that it was appropriate that, since the donation process was similar, there should only be one donation process. This was also approved by the Human Fertilisation and Embryology Authority (HFEA). The investigation aims are summarised below.
• In addition to the treatment of infertility, ART techniques can be used to prevent transmission of genetically inherited disease. Abnormalities of the genes in mitochondria (the power sources in cells) are an important cause of genetic disease, which can cause still births or death early in life. Diseases associated with mutations in the mitochondria are transmitted from mother to child, and a woman who is herself relatively symptom-free can give birth to severely affected children. Our previous research in this field led to ground-breaking clinical ART treatments being offered as ‘world first’ to prevent transmission of mitochondrial disease from mother to child. This involves transferring the pronucleus from embryo of the affected woman to the fertilised egg of a healthy donor whose pronucleus has been removed. The resulting embryo will contain the genetic material of the parents but the healthy mitochondria from the donor. We now aim to further optimise the ‘mitochondrial donation’ procedures by using different techniques. We want to study the mitochondrial genome inheritance, its role in egg development, how it affects early embryo development and look at strategies to overcome barriers in prevention of disease. We will derive embryonic stem cell lines from embryos and from reconstructed embryos.
• It is well known that as a woman gets older, there is decline in her fertility and a higher risk of chromosome errors in children born such as Down’s syndrome. We are interested in studying the pathways that result in these chromosome errors in the eggs and early embryo development and test the feasibility of intervention strategies to reduce the risk of these errors. This research will study the processes that occur in the human egg just before fertilisation and over the next few days. We will transfer the nucleus from one egg to another so that we can study how the mitochondria are passed between cells. This research will involve studying both the nuclear and mitochondrial genomes (DNA).
• It is proposed to use DNA editing tools to study early embryo development for research purposes. This research is subject to approval from the HFEA.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Clinical Laboratory Study;
You can take part if:
You may not be able to take part if:
Exclusion criteria 1. Patients undergoing assisted reproductive technology treatments. -Patients who decline to be approached about research 2. Potential altruistic egg donors (healthy volunteers) -Female age < 18 or > = 46 years -Those deemed ineligible for any reason by the CI/PI based on medical and clinical indications -Participating in any interventional drug trial for the duration of the treatment regimen 3. Altruistic sperm donors (Healthy volunteers) -Male age > 45 years -Those deemed ineligible based on semen quality
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST and funded by Wellcome Trust .
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for Trial ID: CPMS 40423
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