Mitochondrial Donation: An 18 Month Outcome Study.
ConditionMitochondrial Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorNewcastle-upon-Tyne Hospitals NHS Trust
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- observational
Treatment groups
No treatment groups listed
Sponsors and collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Lead sponsor
Wellcome Trust
Collaborator
Source ClinicalTrials.gov