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Mitochondrial Donation: An 18 Month Outcome Study.

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ClinicalTrials.gov Identifier: NCT04113447
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Tracking Information
First Submitted Date August 13, 2018
First Posted Date October 2, 2019
Last Update Posted Date October 2, 2019
Actual Study Start Date November 1, 2017
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 1, 2019)
A normal neurodevelopmental quotient scored using a Bayley-III at 18 months (corrected [ Time Frame: 18 months ]
A normal neurodevelopmental quotient scored using a Bayley-III score at 18 months
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 1, 2019)
  • 1)Normal hearing as assessed by formal audiology, [ Time Frame: 18 months ]
    Formal Audiology
  • 2)Normal vision as assessed by ophthalmologist [ Time Frame: 18 months ]
    Ophthalmology Assessment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mitochondrial Donation: An 18 Month Outcome Study.
Official Title Mitochondrial Donation: An 18 Month Outcome Study.
Brief 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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women with mitochondrial disease undergoing mitochondrial donation treatment
Condition Mitochondrial Diseases
Intervention Other: observational
observational
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 1, 2019)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04113447
Other Study ID Numbers 8075
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Newcastle-upon-Tyne Hospitals NHS Trust
Study Sponsor Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators Wellcome Trust
Investigators Not Provided
PRS Account Newcastle-upon-Tyne Hospitals NHS Trust
Verification Date October 2019