A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT
Exposure to Endocrine Disruptors and Occurrence of Hypospadias: Toxicological, Environmental and Hormonal Imbalance Study
University Hospital, Montpellier
200 participants
Oct 3, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria8
- 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)
Exclusion Criteria6
- 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
- Biological mother/child pairs if a genetic variant explaining hypospadias is found during genetic analysis.
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Interventions
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.
During visit 1, a pediatric urologist or pediatric endocrinologist will perform a clinical examination to confirm the absence of hypospadias. 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06628375