Ignite Creation Date:
2024-05-06 @ 2:53 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02149485
Status:
UNKNOWN
Last Update Posted:
2017-01-16
First Post:
2014-05-20
Brief Title:
Follow-up of 5-year Old Children Born After PGD
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Long-term Safety of Preimplantation Genetic Diagnosis Follow-up of 5-year Old Children Born After PGD
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 fertilisationintracytoplasmatic sperm injection IVFICSI and the parents of the two latter groups of children
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 fertilisationintracytoplasmatic sperm injection IVFICSI and the parents of the two latter groups of children
Detailed Description:
Parents are asked to fill out questionnaires on their own and their childs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None