Preimplantation Genetic DiagnosisNCT02149485
Follow-up of 5-year Old Children Born After PGD
An observational study of Preimplantation Genetic Diagnosis, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Preimplantation Genetic Diagnosis
- How many people
- 300 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 5 years old children born after preimplantation genetic diagnosis
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Maastricht University Hospital
Maastricht, Limburg, 6202AZ
Christine de Die-Smulders, MD PhD, +31 43 3875897, c.dedie@mumc.nl
- Not yet recruiting
University Medical Center Utrecht
Utrecht, Utrecht
Madelon meijer, m.hoogeveen@umcutrecht.nl
About this study
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.
Read the 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.
- Conditions
- Preimplantation Genetic Diagnosis
- Keywords
- PGD,, follow up
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
Psychological health of 5 and 8 years old children born after preimplantation genetic diagnosis
Psychological health will be assesses by neuropsychological testing, and questionaires
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preimplantation Genetic DiagnosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine de Die- Smulders, Maastricht University Medical Center
- Investigators
- Christine de Die-Smulders, MD PhD, Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149485
- Sponsor's protocol ID
- 13-2010
- Status last verified
- Jan 2017
- First submitted
- 20 May 2014
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31005312Heijligers 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.
PubMed 30265304
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Safety of Preimplantation Genetic Diagnosis. Follow-up of 5-year Old Children Born After PGD.
- ClinicalTrials.gov ID
- NCT02149485
- Acronym / sponsor ID
- 13-2010
- Conditions
- Preimplantation Genetic Diagnosis
- Keywords
- PGD,, follow up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 5 years old children born after preimplantation genetic diagnosis
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical health of 5 years old children born after preimplantation genetic diagnosis
Time frame: 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.
1 secondary outcome
Psychological health of 5 and 8 years old children born after preimplantation genetic diagnosis
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Derived from this study: PubMed 31005312Heijligers 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.
- Derived from this study: PubMed 30265304Heijligers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine de Die-Smulders, MD PhD principal investigator
Maastricht University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preimplantation Genetic Diagnosis, run by Maastricht University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine de Die-Smulders, MD PhD (+31 43 3875897, c.dedie@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical health of 5 years old children born after preimplantation genetic diagnosis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02149485, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.