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Follow-up of 5-year Old Children Born After PGD

NCT02149485 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2017-01-16

No results posted yet for this study

Summary

Since 1995, preimplantation genetic diagnosis (PGD) has been performed in The Netherlands for couples at high risk for transmitting severe or lethal genetic conditions or who have experienced multiple miscarriages due to chromosomal translocations. Approximately 260 children have been born after PGD in The Netherlands. Follow-up data on children born after PGD are scarce. Long-term studies on PGD children have not been conducted in The Netherlands. Results of studies in other countries on 2-year old PGD children are reassuring. These children and their parents have normal scores on relevant parameters such as general health, cognitive and socioemotional development, parent-child interaction and parental stress. Studies of good methodological quality of older children have not yet been published.

Objective: Long-term follow-up of children who have been born after PGD in The Netherlands. The primary aim is to assess the safety of PGD with regard to the health and development of the children.

Study design: A cohort study. Study population: 5- and 8 year old children born after PGD in The Netherlands for various indications and their parents. Control groups consist of 5 and 8-year old naturally conceived (NC) children of parents who have considered PGD treatment and 5 and 8-year old children born after in vitro fertilisation/intracytoplasmatic sperm injection (IVF/ICSI), and the parents of the two latter groups of children.

Conditions

  • Preimplantation Genetic Diagnosis

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Christine de Die-Smulders, MD PhD · Maastricht University Hospital

Eligibility

Min Age
5 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149485 on ClinicalTrials.gov