The 'oestrogen hypothesis'- where do we stand now?
Richard M Sharpe
https://pubmed.ncbi.nlm.nih.gov/12534932/Actively Recruiting
Led by University Hospital, Montpellier · Updated on 2025-11-26
200
Participants Needed
1
Research Sites
N/A
Total Duration
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
A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT
N
Nicolas KALFA, Prof
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University Hospital, Montpellier
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants attend a single consultation visit where a pediatric specialist confirms diagnosis status, collects questionnaire data on environmental exposures, and obtains biological samples including hair from the mother and blood from the child for toxicological, hormonal, and genetic analyses.
1 visit (in-person)
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor