Actively Recruiting

Age: 1Month +
All Genders
Healthy Volunteers
NCT06628375

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

Led by University Hospital, Montpellier · Updated on 2025-11-26

200

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 first group consists of biological mothers who have given birth to children with hypospadias (Case Group), while the second group consists of biological mothers who have given birth to children without any malformations (Control Group). Through an integrative approach that combines a direct toxicological study of numerous pollutants present during pregnancy, and a comprehensive exposome assessment using validated tools, this study can significantly enhance our understanding and prevention of this malformation.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Month +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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 affiliated with or beneficiaries of a national health insurance plan
  • Biological mother who is fluent in written and spoken French
  • For Case Group: child has isolated anterior or middle hypospadias without complex genital variations, malformation syndrome, or identified genetic cause
  • For Control Group: child has no complex genital variations such as hypospadias, borderline penis size, cryptorchidism, or retractile testes
Not Eligible

You will not qualify if you...

  • 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
  • For Case Group: pairs where a genetic variant explaining hypospadias is found during genetic analysis

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

CRMR DEVGEN CHU Lapeyronnie

Montpellier, Hérault, France, 34090

Actively Recruiting

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Research Team

N

Nicolas KALFA, Prof

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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