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

• Conditions: Preimplantation Genetic Diagnosis

• Registration Number: NCT02149485
• Lead Sponsor: Maastricht University Medical Center

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 fertilisation/intracytoplasmatic sperm injection (IVF/ICSI), and the parents of the two latter groups of children.

Detailed Description

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-29
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical health of 5 years old children born after preimplantation genetic diagnosis	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Psychological health of 5 and 8 years old children born after preimplantation genetic diagnosis	5 years	Psychological health will be assesses by neuropsychological testing, and questionaires

Trial Locations

Locations (2)

Maastricht University Hospital; 🇳🇱 Maastricht, Limburg, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands