NCT04113447

Mitochondrial Donation: An 18 Month Outcome Study.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

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 (corrected for gestational age). The null hypothesis for this research is that children born following the use of Mitochondrial Donation (IVF) techniques have normal neurodevelopment developmental outcomes at 18 months.

Conditions

• Mitochondrial Diseases

Interventions

Type	Name	Description
OTHER	observational	observational

Timeline

• Start date: 2017-11-01
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2019-10-02
• Last updated: 2025-07-20

Locations

1 site across 1 country: United Kingdom