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.
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Major malformation rate, general health, cognitive and socioemotional
development, parent-child interaction and parental stress.
Secondary outcome
-most important factors in the decision making process of whether to opt for
PGD treatment (for parents of 5 year old children)
-the presence of clinically relevant imprinting defects (future study for 5 and
8 year old children)
- cardiovascular evaluation (8 year old children)
Background summary
Since 1995, preimplantation genetic diagnosis (PGD) has been performed in The
Netherlands for couples at high risk for transmitting severe genetic
conditions or who have experienced multiple miscarriages due to chromosomal
translocations. Approximately 600 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 on
older children have not yet been published.
Study 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. 5-year old PGD children will be compared with two groups of
children, children that are conceived spontaneously by parents who have
attented the PGD clinic for an intake, but have become spontaneously pregnant
afterwards. In this manner, we control for the upbringing in a family with
genetic abnormalities (spontaneously conceived children) and for fertility
treatment without embryo biopsy (IVF/ICSI)
De 5 jarigen worden wederom gevraagd voor onderzoek op 8 jarige leeftijd,
waarbij ook de cardiovasculaire risicostatus wordt onderzocht.
The participants of the 5 year old study will be asked to participate in the
study for 8 year old children. The cardiovacular status will also be examined
in the latter group.
Study burden and risks
Children born after PGD are a unique study group. These children have not been
studied extensively in The Netherlands. In the international scientific
literature, data on the follow-up of PGD children are scarce.
The study procedure consists of filling out questionnaires and a one-time visit
to the hospital. No invasive interventions will be performed in the 5 year old
children. In teh 8 year old one tube of blood will be taken if consent is
given. In our opinion, the risks associated with the study procedure are small.
The results provide more information about the risks of PGD to the children
themselves, to their parents, to prospective parents who are considering PGD
and to healthcare providers involved in PGD treatment.
Joseph Bechlaan 113
Maastricht 6229 GR
NL
Joseph Bechlaan 113
Maastricht 6229 GR
NL
Listed location countries
Age
Inclusion criteria
5-year old children, singleton or part of twins or triplets, born after either PGD, spontaneous conception after their parents have considered PGD or have undergone prenatal diagnosis (chorionic villus biopsy or amniocentesis) or after IVF/ICSI. At least one of the parents of the children must be willing to participate.
Enough competence of the the Dutch language ;8-year old children who have participated in het follow up study at the age of 5
Exclusion criteria
Children with known chromosomal abnormalities or gene disorders
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02149485 |
| CCMO | NL43048.068.13 |