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

A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT | DecenTrialz