Question to the Department of Health and Social Care:

To ask Her Majesty’s Government how they intend to conduct clinical trials for pronuclear transfer and maternal spindle transfer should Parliament approve the draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015.

If approved, the Draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 will enable mitochondrial donation as a treatment. Safety and efficacy have been considered in depth throughout the consultation process on these techniques. It is recognised that for any new IVF technique there will need to be careful monitoring of the procedure and, subsequently, any pregnancies. Although treatments provided would not take the form of a clinical study, evidence produced from the treatments would form an important part of the ongoing assessment of the safety and efficacy of the techniques.