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Recruiting NCT04113447

Mitochondrial Donation: An 18 Month Outcome Study.

— Observational Mitochondrial Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observational.
Who it may be relevant to
Registry conditions: Mitochondrial Diseases. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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

The null hypothesis for this research is that children born following the use of Mitochondrial Donation (IVF) techniques have normal neurodevelopment developmental outcomes at 18 months.

Interventions

  • Other observational
    observational

Primary outcome measures

  • A normal neurodevelopmental quotient scored using a Bayley-III ( Bayley Scales of Infant and Toddler Development, Third Edition) at 18 months (corrected [Time frame: 18 months]
Secondary outcome measures (2)
  • 1)Normal hearing as assessed by formal audiology, [Time frame: 18 months]
  • 2)Normal vision as assessed by ophthalmologist [Time frame: 18 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United Kingdom · 1 center
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne

Identifiers

NCT: NCT04113447 · 8075

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗