Evaluation of the Prevalence of Asthma in a Cohort of Children Born After IVF (Aged 11-15) Compared With a Control Group

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Other: Comparative epidemiological survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Case : 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: 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 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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 448 children<br>Children aged 11-15 years from a historical cohort born after In Vitro Fertilization or Intracytoplasmic Sperm Injection at Hospital Saint Joseph of Marseille | Other: Comparative epidemiological survey<br>* 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).<br>|
| 1344 children<br>Children aged 11-15 years born spontaneously schooling in the same geographic area as case | Other: Comparative epidemiological survey<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of asthma | (will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey). | 15 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of chronic diseases other than asthma | (will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey) | 15 month | 
| Physical well-being | (will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey) | 15 month | 
| Anthropometric measures | (will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey) | 15 month | 
| Age of puberty in girls | (will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey) | 15 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In Vitro Fertilization, follow-up of children