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

NCT02149485 | Unknown DMC

• 1 other identifier: 13-2010
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Preimplantation Genetic Diagnosis

Keywords

PGD,; follow up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Psychological health of 5 and 8 years old children born after preimplantation genetic diagnosis

  5 years

Eligibility Criteria

• Age: 5 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

5 years old children born after preimplantation genetic diagnosis

You may qualify if:

• PGD children
• 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
• 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
• 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

You may not qualify if:

• 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
• years old group Former participants of the study in 5 year old children

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (2)

Maastricht University Hospital

Maastricht, Limburg, 6202AZ, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

NOT YET RECRUITING

Related Publications (2)

• Heijligers M, Peeters A, van Montfoort A, Nijsten J, Janssen E, Gunnewiek FK, de Rooy R, van Golde R, Coonen E, Meijer-Hoogeveen M, Broekmans F, van der Hoeven M, Arens Y, de Die-Smulders C. Growth, health, and motor development of 5-year-old children born after preimplantation genetic diagnosis. Fertil Steril. 2019 Jun;111(6):1151-1158. doi: 10.1016/j.fertnstert.2019.01.035. Epub 2019 Apr 17.

  PMID: 31005312 DERIVED

• Heijligers M, Verheijden LMM, Jonkman LM, van der Sangen M, Meijer-Hoogeveen M, Arens Y, van der Hoeven MA, de Die-Smulders CEM. The cognitive and socio-emotional development of 5-year-old children born after PGD. Hum Reprod. 2018 Nov 1;33(11):2150-2157. doi: 10.1093/humrep/dey302.

  PMID: 30265304 DERIVED

Study Officials

• Christine de Die-Smulders, MD PhD

  Maastricht University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine de Die-Smulders, MD PhD

CONTACT

+31 43 3875897; c.dedie@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 29, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 16, 2017

Record last verified: 2017-01

Locations

NL (2)