An observational study in Mitochondrial Diseases, sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to female participants. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by Newcastle-upon-Tyne Hospitals NHS Trust · Observational
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.
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.
189 studies on the registry are indexed under Mitochondrial Diseases; 60 are open to participants now.
This study's planned enrollment of 25 is below the median of 80 across 65 observational studies indexed under Mitochondrial Diseases.
Browse Mitochondrial Diseases studies →Newcastle-upon-Tyne Hospitals NHS Trust is the lead sponsor of 67 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women with mitochondrial disease undergoing mitochondrial donation treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women will only be eligible if they meet all of the following criteria.
Exclusion Criteria:
Women will not be eligible if they meet any of the following criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
observational
A normal neurodevelopmental quotient scored using a Bayley-III ( Bayley Scales of Infant and Toddler Development, Third Edition) at 18 months (corrected
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.
Time frame: 18 months
1)Normal hearing as assessed by formal audiology,
Formal Audiology
Time frame: 18 months
2)Normal vision as assessed by ophthalmologist
Ophthalmology Assessment
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2017 (actual). Primary completion is estimated for Nov 2027, 120 months after the start.
Of 33 observational studies under Mitochondrial Diseases, half reached primary completion within 169 months of starting (the median), counting those still running; a quarter within 26. This study's planned 120 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Newcastle-upon-Tyne Hospitals NHS Trust