RecruitingNCT04113447

Mitochondrial Donation: An 18 Month Outcome Study.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Enrollment

25 participants

Start Date

Nov 1, 2017

Study Type

OBSERVATIONAL

Conditions

Mitochondrial Diseases

Summary

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

Sex: FEMALE

Inclusion Criteria6

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)

Exclusion Criteria4

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)

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