Evaluation of the Prevalence of Asthma in a Cohort of Children Born After IVF (Aged 11-15) Compared With a Control Group
NCT ID: NCT02636179
Last Updated: 2015-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1792 participants
OBSERVATIONAL
2015-12-31
2017-09-30
Brief Summary
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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
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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
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
Comparative epidemiological survey
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).
1344 children
Children aged 11-15 years born spontaneously schooling in the same geographic area as case
Comparative epidemiological survey
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).
Interventions
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Comparative epidemiological survey
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).
Eligibility Criteria
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Inclusion Criteria
* Children conceived by Intraconjugal In Vitro Fertilization/Intracytoplasmic Sperm Injection treatment
* Children aged 11-15 years
* Singleton and twins
* School children
* Control :
* Children born spontaneously (without IVF)
* Children aged 11-15 years
* Children in the same place of schooling of the case
Exclusion Criteria
* 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
* 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
11 Years
15 Years
ALL
No
Sponsors
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Hospital St. Joseph, Marseille, France
OTHER
Responsible Party
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Pierre Boyer
Head of Assisted Reproductive Technologies Laboratory
Locations
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Hôpital Saint Joseph de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Pierre Boyer, MD
Role: primary
References
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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.
Meddeb 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.
Other Identifiers
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RCB 2015-A00997-42
Identifier Type: -
Identifier Source: org_study_id