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

NCT06628375 | Recruiting DMC

• 1 other identifier: RECHMPL22_0559
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 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

Hypospadias

Keywords

Endocrine-disrupting chemicals; Birth defect; Environment; Hormones minipuberty; Exposome; Toxicology hair

Outcome Measures

Primary Outcomes (1)

• Evaluation of toxic exposure via hair sample analysis

  An assessment of toxic substance concentrations in maternal hair will evaluate exposure to a wide range of pollutants. The collected hair samples will provide data representing the period from three months before conception to the date of study enrollment. The study will analyze 150 chemical substances and measure their concentrations to assess mothers' exposure to these pollutants during pregnancy.

  Day 1 (Visit 1)

Secondary Outcomes (4)

• Exposome through validated European questionnaires (QLK4-1999-01422)

  Day 1 (Visit 1)

• Exposome professionnel

  Day 1 (Visit 1)

• Pollutant dispersion model

  Day 1 (Visit 1)

• Hormonal analysis by immunoassay principle

  Day 1 (Visit 1)

Study Arms (2)

Case Group

Biological mother and son with hypospadias

Other: Consultation visit (Visit 1)

Control Group

Biological mother and son without hypospadias

Other: Consultation visit (Visit 1)

Interventions

Consultation visit (Visit 1) OTHER

During visit 1, a pediatric urologist or pediatric endocrinologist will perform a clinical examination to confirm the diagnosis of hypospadias, as a part of routine care. The clinical study investigator will ask to fill out a validated European questionnaire for the exposome and use an occupation/exposure matrix to identify specific atmospheric exposure. A hair sample from the biological mother will be taken for toxicological evaluation of substances accumulated during pregnancy. From the child, a blood sample will be taken for hormonal evaluation of minipuberty and then, another sample in a 5 ml EDTA tube will be taken for DNA collection.

Case Group

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Case Group: Biological mother and child with hypospadias Control group: Biological mother and child without hypospadias

You may qualify if:

• 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
• \- 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
• \- The child must not present any complex variations in genital development (hypospadias, borderline penis size, unilateral or bilateral cryptorchidism, retractile testes)

You may not qualify if:

• 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 included in another clinical study involving a drug
• Biological mother/child pairs if a genetic variant explaining hypospadias is found during genetic analysis.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CRMR DEVGEN CHU Lapeyronnie

Montpellier, Hérault, 34090, France

RECRUITING

Related Publications (25)

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Biospecimen

Retention: SAMPLES WITH DNA

A blood sample into 5 ml EDTA tube may also be taken from the child with hypospadias, for a DNA collection. The remaining hair sample will be kept to measure new pollutant molecules, depending on scientific advancements.

MeSH Terms

Conditions

Hypospadias; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nicolas KALFA, Prof

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas KALFA, Prof

CONTACT

0467338784; n-kalfa@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 8, 2024
• Study Start: October 3, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 3, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

FR (1)