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

Study Overview
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Brief Summary
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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.

Detailed Description
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Parents are asked to fill out questionnaires on their own and their child's medical history. A physical examination of the children will be performed, a swab for collection of buccal cells for (future) DNA methylation analysis will be taken and their cognitive and socioemotional development will be assessed. In the 8 years old children cardiovascular status will be evaluated. Main study parameters: general health, cognitive and socioemotional development, parent-child interaction and parental stress. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study procedure consists of filling out questionnaires by parents and a one-time visit to the hospital. No invasive interventions will be performed, except 1 tube of blood in the 8 year old group. The risks associated with the study procedure are very small. The results provide more information about the risks of PGD to prospective parents who are considering PGD and to healthcare providers involved in PGD treatment.

Official Title
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Long-term Safety of Preimplantation Genetic Diagnosis. Follow-up of 5-year Old Children Born After PGD.

Conditions
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Preimplantation Genetic Diagnosis

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: PGD children 5-year old singleton PGD children with Caucasian parents Children must have the Dutch language as their mother tongue for participation in the intelligence quotient (IQ) test. Children that do not have Dutch as their mother tongue will be excluded from the IQ test, but can take part in the rest of the procedure Naturally conceived (NC) children 5-year old singleton NC children with Caucasian parents, matched with PGD children on age and sex Parents must have attended the PGD clinic in Maastricht for an informative consultation Parents must have become pregnant without any assisted reproductive technique Children must have the Dutch language as their mother tongue IVF/ICSI children 5-year old singleton IVF/ICSI children with Caucasian parents, matched with PGD children on age and sex Children must have the Dutch language as their mother tongue Exclusion criteria: PGD children Twins or triplets Parents of non-Caucasian descent Children with known chromosomal abnormalities (e.g. trisomy 21) or gene disorders with childhood expression of symptoms NC children Twins or triplets Parents of non-Caucasian descent Children with known chromosomal abnormalities or gene disorders with childhood expression of symptoms IVF/ICSI children Twins or triplets Parents of non-Caucasian descent Children with known chromosomal abnormalities or gene disorders with childhood expression of symptoms 8 years old group Former participants of the study in 5 year old children

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical health of 5 years old children born after preimplantation genetic diagnosis | Physical health of 5 and 8 years old children born after PGD will be assessed by physical examination and measurement of height, weight and compared with children born after IVF/ICSI and naturally conceived children. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological health of 5 and 8 years old children born after preimplantation genetic diagnosis | Psychological health will be assesses by neuropsychological testing, and questionaires | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PGD,, follow up