Examining the link between endocrine disruptors and hypospadias

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the relationship between exposure to endocrine-disrupting chemicals (EDCs) and the occurrence of hypospadias in male infants. It involves a multicenter comparative case-control design, where biological mothers of boys with hypospadias are compared to those with healthy boys. The study employs a combination of toxicological assessments of pollutants and an exposome evaluation to understand environmental impacts during pregnancy. By analyzing these factors, the research aims to enhance knowledge about the prevention of this birth defect.

Why it matters

Who can join: the full rules

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.

Where it's running

• CRMR DEVGEN CHU Lapeyronnie
  Montpellier, Hérault, France Recruiting

Study contacts

• Principal investigator: Nicolas KALFA, Prof — University Hospital, Montpellier
• Study coordinator: Nicolas KALFA, Prof
• Email: n-kalfa@chu-montpellier.fr
• Phone: 0467338784

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• PREDICT-H: Improving prediction of complications after hypospadias surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.