Mitochondrial Donation: An 18 Month Outcome Study.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2027-11-30

Brief Summary

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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.

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Detailed Description

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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

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Mitochondrial Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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observational

Intervention Type OTHER

Eligibility Criteria

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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)

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No