Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04113447

Mitochondrial Donation: An 18 Month Outcome Study.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Mitochondrial Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Observational

Primary location

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne & Wear, NE1 4LP, United Kingdom

Location status: Recruiting

Location contact

Robert McFarland

CONTACT

[email protected]

0191 2820340

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Observational

Other

observational

Primary outcomes

  1. 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

    The Bayley Scale of Infant and Toddler Development, Third Edition (Bayley III) measures physical, motor, sensory, and cognitive development in babies and young children. The scale encompasses five developmental domains - cognitive, language, motor, social-emotional and adaptive behaviour. The structure of the Bayley-III Scales allows clinicians to administer each of the five scales (cognitive, language-receptive and expressive, motor-fine and gross, social-emotional, and adaptive behaviour) independent of others. Higher scores in each scale indicates more advanced development. Performance is summarised via scaled scores for each subtest, and composite scores for each scale, together with percentile ranks, developmental age equivalents, and growth scores. Discrepancy information is used to determine whether there are significant differences between a child's abilities in the domains measured, and how prevalent these differences are in the norming sample. A total score is not provided.

Secondary outcomes

  1. 1)Normal hearing as assessed by formal audiology,

    Time frame: 18 months

    Formal Audiology

  2. 2)Normal vision as assessed by ophthalmologist

    Time frame: 18 months

    Ophthalmology Assessment

Sponsors and collaborators

Lead sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Other

Collaborators

  • Wellcome Trust

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Oct 2, 2019
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.