Trials / Unknown
UnknownNCT02636179
Evaluation of the Prevalence of Asthma in a Cohort of Children Born After IVF (Aged 11-15) Compared With a Control Group
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,792 (estimated)
- Sponsor
- Hospital St. Joseph, Marseille, France · Academic / Other
- Sex
- All
- Age
- 11 Years – 15 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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). |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2017-01-01
- Completion
- 2017-09-01
- First posted
- 2015-12-21
- Last updated
- 2015-12-21
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02636179. Inclusion in this directory is not an endorsement.