Preimplantation Genetic Diagnosis Clinical Trial
Official title:
Long-term Safety of Preimplantation Genetic Diagnosis. Follow-up of 5-year Old Children Born After PGD.
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.
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.
;
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