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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 5 Years to 5 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Maastricht University Hospital | Maastricht | Limburg |
| Netherlands | University Medical Center Utrecht | Utrecht |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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