EICHORCondition: Mitochondrial Diseases · Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
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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.
This description comes directly from the study's public registry record.
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Inclusion Criteria: 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 Criteria: 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)
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne, Tyne & Wear, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04113447