AsthmaEMCeFIVNCT02636179
Evaluation of the Prevalence of Asthma in a Cohort of Children Born After IVF (Aged 11-15) Compared With a Control Group
An observational study of Asthma, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
Assisted Reproduction Technologies (ART) are increasingly being used worldwide as a result of fertility decline likely caused by changes in both environment and social behaviour. Considering this large usage, it is important to evaluate the potential risk on the health of children conceived using ART. Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- Comparative epidemiological survey
- Type of treatment
- Injection or infusion
- How many people
- 1,792 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Sep 2017
- 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 11 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: The investigators will include children born after In Vitro Fertilization/Intracytoplasmic Sperm Injection treatment from a historic cohort and children born spontaneously (without ART), attending schools in the same geographic area as IVF/ICSI children. Parents will be contacted before to include children.
Who may be able to join
- Case :
- Children conceived by Intraconjugal In Vitro Fertilization/Intracytoplasmic Sperm Injection treatment
- Children aged 11-15 years
- Singleton and twins
- School children
- Control :
Show all 9Show fewer
- Children born spontaneously (without IVF)
- Children aged 11-15 years
- Children in the same place of schooling of the case
Who cannot join
- Case :
- Children not born by Intraconjugal In Vitro Fertilization/Intracytoplasmic Sperm Injection treatment (donor)
- Children whose parents refuse the participation
- Triplet and more pregnancies
- Children who cannot attend ordinary school
- Children from families where an infant has passed away
Show all 12Show fewer
- When the participation agreement was not signed
- Control :
- Children whose parents have benefited ART
- When the participation agreement was not signed
- Children whose aged and sex are unknown
- Triplet and more pregnancies
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Joseph de Marseille
Marseille, 13008
Pierre Boyer, MD, +33 49 18 06 458, pboyer@hopital-saint-joseph.fr
About this study
Official title: Evaluation of the Prevalence of Asthma in a Cohort of Children Born After In Vitro Fertilization (Aged 11-15) Compared With Spontaneously Conceived Children of the Same Age Range
Assisted Reproduction Technologies (ART) are increasingly being used worldwide as a result of fertility decline likely caused by changes in both environment and social behaviour. Considering this large usage, it is important to evaluate the potential risk on the health of children conceived using ART.
According to the literature, children born after ART are more likely to be at higher risk of health problems than spontaneously conceived ones. Interestingly, recent studies suggested an increase of asthma prevalence in children conceived using In Vitro Fertilization (IVF).
Read more
The purpose of this study is to evaluate the prevalence of asthma in school adolescents from a cohort of children born after In Vitro Fertilization (IVF), aged 11-15 years as compared to a control group composed of the same age range spontaneously conceived individuals.
The expected outcome of this study will provide new information regarding these children to ART professionals of and to their own families, by focusing on an age range (between 11 and 15 years) for which very little information is available to date.
Read the detailed description
The methodology is a comparative epidemiological survey, between children from a historical cohort born after intraconjugal In Vitro Fertilization (singleton or twin) aged 11-15 years and a control group recruited in schools after the agreement of Academic Inspection.
Parents of the two groups will be contacted either by phone calls or through written information given in the schools. They will receive the questionnaire and an information letter, once they give their agreement to be a part of the study.
Data collection will be conducted using two anonymous questionnaires. The first questionnaire was built based on items proposed in the international Health Behaviour in School-aged Children (HBSC) survey of the World Health Organization (WHO). The second questionnaire will be sent to parents. It will focus on the pregnancy and it will be used to adjust the analysis.
This study was submitted and approved by an Institutional Review Board in France (Comité de Protection des Personnes Sud-Méditerranée II) on 11th September 2015.
- Conditions
- Asthma
- Being tested
- Comparative epidemiological survey
- Keywords
- In Vitro Fertilization, follow-up of children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparative epidemiological surveyOther
The method used to select the control group will be the random sampling of eligible schools. It will be defined according to the place of schooling of the historic cohort of children. The children will be matched as close as possible based on sex, age, school class and type of school (public/private).
| Study group | Role | What they receive |
|---|---|---|
| 448 children | Children aged 11-15 years from a historical cohort born after In Vitro Fertilization or Intracytoplasmic Sperm Injection at Hospital Saint Joseph of Marseille Receives: Other: Comparative epidemiological survey | |
| 1344 children | Children aged 11-15 years born spontaneously schooling in the same geographic area as case Receives: Other: Comparative epidemiological survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of asthma
(will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey).
Measured: 15 month
Secondary outcomes (4)
Prevalence of chronic diseases other than asthma
(will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey)
Measured: 15 month
Physical well-being
(will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey)
Measured: 15 month
Anthropometric measures
(will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey)
Measured: 15 month
Age of puberty in girls
(will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey)
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2017 (estimated)
- Study completionSep 2017 (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 AsthmaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,792 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Boyer, Hospital St. Joseph, Marseille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636179
- Sponsor's protocol ID
- RCB 2015-A00997-42
- Acronym
- EMCeFIV
- Status last verified
- Dec 2015
- First submitted
- 14 Dec 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anzola AB, Pauly V, Geoffroy-Siraudin C, Gervoise-Boyer MJ, Montjean D, Boyer P. The first 50 live births after autologous oocyte vitrification in France. J Assist Reprod Genet. 2015 Dec;32(12):1781-7. doi: 10.1007/s10815-015-0603-2. Epub 2015 Oct 30.
PubMed 26519416Meddeb L, Boyer M, Pauly V, Tourame P, Rossin B, Pfister B, Boyer P. [Procedure used to follow-up a cohort of IVF children. Interests and limits of tools performed to longitudinal follow up for a monocentric cohort]. Rev Epidemiol Sante Publique. 2011 Apr;59(2):97-105. doi: 10.1016/j.respe.2010.11.004. Epub 2011 Mar 22. French.
PubMed 21429679
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Asthma in a Cohort of Children Born After In Vitro Fertilization (Aged 11-15) Compared With Spontaneously Conceived Children of the Same Age Range
- ClinicalTrials.gov ID
- NCT02636179
- Acronym / sponsor ID
- EMCeFIV / RCB 2015-A00997-42
- Conditions
- Asthma
- Keywords
- In Vitro Fertilization, follow-up of children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,792 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 21 Dec 2015 (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.
Assisted Reproduction Technologies (ART) are increasingly being used worldwide as a result of fertility decline likely caused by changes in both environment and social behaviour. Considering this large usage, it is important to evaluate the potential risk on the health of children conceived using ART.
According to the literature, children born after ART are more likely to be at higher risk of health problems than spontaneously conceived ones. Interestingly, recent studies suggested an increase of asthma prevalence in children conceived using In Vitro Fertilization (IVF).
The purpose of this study is to evaluate the prevalence of asthma in school adolescents from a cohort of children born after In Vitro Fertilization (IVF), aged 11-15 years as compared to a control group composed of the same age range spontaneously conceived individuals.
The expected outcome of this study will provide new information regarding these children to ART professionals of and to their own families, by focusing on an age range (between 11 and 15 years) for which very little information is available to date.
Detailed description
The methodology is a comparative epidemiological survey, between children from a historical cohort born after intraconjugal In Vitro Fertilization (singleton or twin) aged 11-15 years and a control group recruited in schools after the agreement of Academic Inspection.
Parents of the two groups will be contacted either by phone calls or through written information given in the schools. They will receive the questionnaire and an information letter, once they give their agreement to be a part of the study.
Data collection will be conducted using two anonymous questionnaires. The first questionnaire was built based on items proposed in the international Health Behaviour in School-aged Children (HBSC) survey of the World Health Organization (WHO). The second questionnaire will be sent to parents. It will focus on the pregnancy and it will be used to adjust the analysis.
This study was submitted and approved by an Institutional Review Board in France (Comité de Protection des Personnes Sud-Méditerranée II) on 11th September 2015.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 448 children | – | Other: Comparative epidemiological surveyChildren aged 11-15 years from a historical cohort born after In Vitro Fertilization or Intracytoplasmic Sperm Injection at Hospital Saint Joseph of Marseille |
| 1344 children | – | Other: Comparative epidemiological surveyChildren aged 11-15 years born spontaneously schooling in the same geographic area as case |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The investigators will include children born after In Vitro Fertilization/Intracytoplasmic Sperm Injection treatment from a historic cohort and children born spontaneously (without ART), attending schools in the same geographic area as IVF/ICSI children. Parents will be contacted before to include children.
Key inclusion criteria (9 listed)
- Case :
- Children conceived by Intraconjugal In Vitro Fertilization/Intracytoplasmic Sperm Injection treatment
- Children aged 11-15 years
- Singleton and twins
- School children
Key exclusion criteria (12 listed)
- Case :
- Children not born by Intraconjugal In Vitro Fertilization/Intracytoplasmic Sperm Injection treatment (donor)
- Children whose parents refuse the participation
- Triplet and more pregnancies
- Children who cannot attend ordinary school
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparative epidemiological surveyThe method used to select the control group will be the random sampling of eligible schools. It will be defined according to the place of schooling of the historic cohort of children. The children will be matched as close as possible based on sex, age, school class and type of school (public/private). | Other | 1344 children, 448 children |
Primary outcome
Prevalence of asthma
Time frame: 15 month
(will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey).
4 secondary outcomes
Prevalence of chronic diseases other than asthma
Time frame: 15 month
Physical well-being
Time frame: 15 month
Anthropometric measures
Time frame: 15 month
Age of puberty in girls
Time frame: 15 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Background: PubMed 26519416Anzola AB, Pauly V, Geoffroy-Siraudin C, Gervoise-Boyer MJ, Montjean D, Boyer P. The first 50 live births after autologous oocyte vitrification in France. J Assist Reprod Genet. 2015 Dec;32(12):1781-7. doi: 10.1007/s10815-015-0603-2. Epub 2015 Oct 30.
- Background: PubMed 21429679Meddeb L, Boyer M, Pauly V, Tourame P, Rossin B, Pfister B, Boyer P. [Procedure used to follow-up a cohort of IVF children. Interests and limits of tools performed to longitudinal follow up for a monocentric cohort]. Rev Epidemiol Sante Publique. 2011 Apr;59(2):97-105. doi: 10.1016/j.respe.2010.11.004. Epub 2011 Mar 22. French.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Hospital St. Joseph, Marseille, France at 1 site in France.
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 9 inclusion and 12 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Marie Raffray, MS (+33 491 80 65 16, mraffray@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of asthma (time frame: 15 month). 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 NCT02636179, 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 21 Dec 2015.