RecruitingNCT04113447

Mitochondrial Donation: An 18 Month Outcome Study.


Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Enrollment

25 participants

Start Date

Nov 1, 2017

Study Type

OBSERVATIONAL

Conditions

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 for gestational age) using the internationally validated Bayley-III developmental assessment tool.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is tracking the outcomes of women who undergo Mitochondrial Donation — a pioneering fertility treatment that allows women carrying mitochondrial DNA mutations to have children without passing on devastating mitochondrial diseases. Mitochondrial diseases are serious conditions caused by defects in the energy-producing parts of cells and can cause severe disability or death in children. This 18-month follow-up study is monitoring both the mothers and any resulting children to ensure safety and inform guidelines. You may be eligible if: - You are a woman with a confirmed mitochondrial DNA (mtDNA) mutation - You are considered suitable for Mitochondrial Donation treatment under a licensed HFEA (Human Fertilisation and Embryology Authority) program - You provide informed consent before treatment begins - You are willing to share health information collected during pregnancy, delivery, and until your child's 18th month of life You may NOT be eligible if: - You have declined Mitochondrial Donation as a treatment - You are unwilling or unable to comply with the study schedule and data-sharing requirements Talk to your reproductive medicine specialist or genetic counselor if you carry a mitochondrial DNA mutation and are considering starting a family — Mitochondrial Donation is a licensed option at specific clinics in the UK.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERobservational

observational


Locations(1)

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne & Wear, United Kingdom

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NCT04113447


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