Actively Recruiting
Mitochondrial Donation: An 18 Month Outcome Study.
Led by Newcastle-upon-Tyne Hospitals NHS Trust · Updated on 2025-07-20
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Newcastle-upon-Tyne Hospitals NHS Trust
Lead Sponsor
W
Wellcome Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to observe the development of children conceived using Mitochondrial Donation (MD), focusing on fetal and postnatal growth. Researchers will assess neurodevelopmental outcomes at 18 months corrected age using the internationally recognized Bayley-III developmental tool. The study tests the hypothesis that children born through MD IVF techniques show normal neurodevelopment at this age. The study involves monitoring children conceived via Mitochondrial Donation without any treatment intervention, as it is observational. Developmental assessments including the Bayley-III are scheduled at 18 months corrected age. Additional evaluations for normal hearing and vision by audiologists and ophthalmologists are also conducted at the same time point. Participants will be followed from pregnancy through delivery until the child reaches 18 months corrected age. Data on pregnancy, delivery, and child development will be collected and reviewed. The primary outcome is the neurodevelopmental score at 18 months, with secondary outcomes including hearing and vision status. The study provides a comprehensive developmental overview over this period, with no active treatment administered.
CONDITIONS
Brief Title
Mitochondrial Donation: An 18 Month Outcome Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with confirmed mitochondrial DNA (mtDNA) mutation
- Suitable to undergo Mitochondrial Donation as a treatment according to HFEA license
- Provided informed consent before starting Mitochondrial Donation treatment
- Able and willing to follow the study protocol and evaluation schedule
- Willing to share pregnancy, delivery, and child development information up to 18 months corrected age
You will not qualify if you...
- Declined Mitochondrial Donation treatment in line with HFEA license
- Unable or unwilling to follow the study protocol and evaluation schedule
- Unwilling to share pregnancy, delivery, and child development information up to 18 months corrected age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants who have undergone Mitochondrial Donation are observed for fetal and postnatal development up to 18 months corrected age.
Visits at key developmental milestones including assessment at 18 months
Trial Site Locations
Total: 1 location
1
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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