Actively Recruiting

FEMALE
NCT04113447

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

525 weeks

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

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.

CONDITIONS

Official Title

Mitochondrial Donation: An 18 Month Outcome Study.

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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