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

Asthma Clinical Trial

— EMCeFIV  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02636179
• Other study ID #: RCB 2015-A00997-42
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2015
• Last updated: December 16, 2015
• Start date: December 2015
• Est. completion date: September 2017

Study information

• Verified date: December 2015
• Source: Hospital St. Joseph, Marseille, France
• Contact: Marie Raffray, MS
• Phone: +33 491 80 65 16
• Email: mraffray[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Health authority: France: ANSM
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1792
• Est. completion date: September 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 15 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

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).

Locations

Country	Name	City	State
France	Hôpital Saint Joseph de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of asthma	(will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey).	15 month	No
Secondary	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	No
Secondary	Physical well-being	(will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey)	15 month	No
Secondary	Anthropometric measures	(will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey)	15 month	No
Secondary	Age of puberty in girls	(will be assessed using the questionnaire of international Health Behaviour in School-aged Children [HBSC] survey)	15 month	No