NCT06628375 A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT
| NCT ID | NCT06628375 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Hypospadias |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-03 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-10-03 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Nicolas KALFA, Prof
PRINCIPAL INVESTIGATOR
University Hospital, Montpellier
Frequently Asked Questions
Who can join the NCT06628375 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, studying Hypospadias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06628375 currently recruiting?
Yes, NCT06628375 is actively recruiting participants. Contact the research team at n-kalfa@chu-montpellier.fr for enrollment information.
Where is the NCT06628375 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT06628375 clinical trial?
NCT06628375 is sponsored by University Hospital, Montpellier. The principal investigator is Nicolas KALFA, Prof at University Hospital, Montpellier. The trial plans to enroll 200 participants.