Status:
RECRUITING
Mitochondrial Donation: An 18 Month Outcome Study.
Lead Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborating Sponsors:
Wellcome Trust
Conditions:
Mitochondrial Diseases
Eligibility:
FEMALE
Brief Summary
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 ...
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 (correct...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04113447
Start Date
November 1 2017
End Date
November 30 2027
Last Update
July 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP