Actively Recruiting
Study of Exposure to Endocrine Disrupting Chemicals and Its Link to Hypospadias in Boys A Multicenter Comparison Between Mothers of Affected and Unaffected Children
Led by University Hospital, Montpellier · Updated on 2025-11-26
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the impact of exposure to Endocrine-Disrupting Chemicals EDCs on the risk of hypospadias, a common birth defect affecting the external genital organs in boys. This multicenter case-control study compares biological mothers of boys with hypospadias Case Group to mothers of boys without malformations Control Group to better understand environmental and hormonal factors that might contribute to this condition. The study aims to clarify how exposure to these chemicals during pregnancy might influence hormonal changes in newborns. The study involves a single consultation visit where a pediatric urologist or endocrinologist will confirm the presence or absence of hypospadias. Mothers will complete a validated European questionnaire and an occupationexposure matrix to assess environmental and occupational exposure to EDCs during pregnancy. Hair samples will be collected from mothers to analyze accumulated toxic substances, and blood samples will be taken from the children to evaluate hormone levels during the neonatal mini-puberty period. For cases, an additional blood sample will be collected for DNA analysis. Participants will attend one visit where clinical examinations, interviews, and sample collections occur. Researchers will measure toxic exposures through hair analysis, assess environmental exposures using questionnaires and models, and evaluate hormonal levels in the children. The study will help improve understanding and prevention of hypospadias by linking environmental exposures and hormonal changes. The total participation involves this single visit, with careful monitoring and data collection during that time.
CONDITIONS
Brief Title
A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents of legal age who have signed informed consent for their child's participation
- Biological mother of a boy aged between 1 and 6 months
- Biological mother with a minimum hair length of 18 cm
- Biological mother who has signed informed consent for her own participation
- Biological mother and child covered by a national health insurance plan
- Biological mother fluent in written and spoken French
- For Case Group: child has isolated anterior or middle hypospadias without other complex genital variations, malformation syndromes, or known genetic causes
- For Control Group: child has no complex genital development variations such as hypospadias or cryptorchidism
You will not qualify if you...
- Child with other congenital anomalies or malformation syndromes
- Child with endocrine diseases
- Biological mother or child under legal protection, guardianship, or curatorship
- Biological mother or child currently in exclusion period from another study
- Biological mother or child participating in another clinical study involving a drug
- For Case Group: pairs where a genetic variant explaining hypospadias is found during genetic analysis
Research Team
N
Nicolas KALFA, Prof
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