Mitochondrial Donation: An 18 Month Outcome Study.

Launched by NEWCASTLE-UPON-TYNE HOSPITALS NHS TRUST · Oct 1, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at how children develop after being conceived using a special technique called Mitochondrial Donation. This method is used to help women who carry certain genetic changes (called mitochondrial DNA mutations) that can cause serious health problems. The study will follow these children from before birth until they are about 18 months old, checking their growth and development using a well-known and trusted assessment tool.

Women who have a confirmed mitochondrial DNA mutation and are eligible for Mitochondrial Donation treatment can take part in this study. To join, they must agree to share information about their pregnancy, delivery, and their child’s development up to 18 months old. Participants will also need to follow the study’s schedule for evaluations during this time. The goal is to better understand how children conceived this way grow and develop, helping doctors and families make informed decisions about this treatment in the future.

Gender

FEMALE

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)