Mitochondrial Donation: An 18 Month Outcome Study.

Recruiting now

Conditions studied: Mitochondrial Diseases

In brief

The Investigator proposes to record the fetal and postnatal development of children conceived using Mitochondrial Donation (MD) and to perform expert assessment of development at 18 months (corrected for gestational age) using the internationally validated Bayley-III developmental assessment tool.

Key facts

Study ID

NCT04113447

Run by

Newcastle-upon-Tyne Hospitals NHS Trust

People needed

25

Starts

2017-11-01

Expected to finish

2027-11-30

Last updated by the study team

2025-07-20

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women will only be eligible if they meet all of the following criteria.
• Women with confirmed mtDNA mutation
• Suitable to undergo Mitochondrial Donation as a treatment (in line with HFEA license)
• Informed Consent for the study obtained before Mitochondrial Donation treatment commences
• Ability and willingness to adhere to the protocol including evaluation schedule
• Willingness to make available information collected during pregnancy, delivery and up to the child's age of 18 months (corrected for gestational age)

You may not qualify if…

• Women will not be eligible if they meet any of the following criteria
• Declined Mitochondrial Donation as a treatment (in line with HFEA license)
• Inability or unwillingness to adhere to the protocol including evaluation schedule
• Unwillingness to make available information collected during pregnancy, delivery and up to the child's age of 18 months (corrected for gestational age)

Where it is running

• The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, Tyne & Wear, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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