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

December 16, 2015 updated by: Pierre Boyer, Hospital St. Joseph, Marseille, France

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).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1792

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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).
1344 children
Children aged 11-15 years born spontaneously schooling in the same geographic area as case
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital St. Joseph, Marseille, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 21, 2015

Study Record Updates

Last Update Posted (Estimate)

December 21, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCB 2015-A00997-42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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