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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Oct 2, 2024

Keywords

ClinConnect Summary

The HYPOLLUT clinical trial is studying how exposure to certain chemicals, known as endocrine disruptors, during pregnancy might affect the risk of a birth defect called hypospadias. Hypospadias is a condition where a boy’s urethra, the tube that carries urine, does not open at the usual spot on the head of the penis. The study involves two groups of mothers: one group has given birth to boys with hypospadias (the Case Group), while the other group has given birth to boys without any genital issues (the Control Group). By comparing these two groups, researchers hope to learn more about how these chemicals may contribute to the occurrence of hypospadias and improve prevention efforts.

To participate in the study, mothers must be at least 18 years old and have a son aged between 3 and 6 months. They should also have long hair (at least 18 cm) and speak and read French. Mothers of boys with hypospadias must ensure that their child does not have any other complex genital issues or genetic conditions. Participants will be asked to provide samples and information about their exposure to various pollutants during pregnancy. This study is currently recruiting, and it aims to improve our understanding of environmental factors that may influence the risk of this condition in newborns.

Gender

ALL

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 3 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.