Status:
RECRUITING
A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Hypospadias
Eligibility:
All Genders
1+ years
Brief Summary
This study aims to demonstrate the impact of Endocrine-Disrupting Chemicals (EDCs) on the risk of hypospadias incidence. It is a multicenter comparative case-control study, involving two groups. The f...
Detailed Description
Background. Hypospadias is a birth defect of the external genital organs in boys and it ranks the second most common genital malformation in male newborns, following cryptorchidism. Its prevalence is ...
Eligibility Criteria
Non-specific Inclusion Criteria :
- Parents of legal age having signed a free and informed consent for the participation of their child
- 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 a free and informed consent for her participation
- Biological mother and child affiliated with or beneficiaries of a national health insurance plan
- Biological mother who is fluent in written and spoken French
Specific Inclusion Criteria for Case Group:
- The child has an isolated anterior or middle hypospadias, without any other complex variations of genital development (borderline penile size, unilateral or bilateral cryptorchidism, retractile testes), without malformation syndrome and without identified genetic etiology
Specific Inclusion Criteria for Control Group:
- The child must not present any complex variations in genital development (hypospadias, borderline penis size, unilateral or bilateral cryptorchidism, retractile testes)
Exclusion Criteria:
- Child with another congenital anomaly or malformative syndrome
- Child with an endocrine pathology
- Biological mother or child under legal protection, guardianship, or curatorship
- Biological mother or child in the exclusion period of a previous study
- Biological mother or child included in another clinical study involving a drug
Specific Exclusion Criteria for Case Group:
Biological mother/child pairs if a genetic variant explaining hypospadias is found during genetic analysis.
Key Trial Info
Start Date :
October 3 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 3 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06628375
Start Date
October 3 2024
End Date
October 3 2027
Last Update
November 26 2025
Active Locations (1)
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1
CRMR DEVGEN CHU Lapeyronnie
Montpellier, Hérault, France, 34090