Examining the link between endocrine disruptors and hypospadias
Exposure to Endocrine Disruptors and Occurrence of Hypospadias: Toxicological, Environmental and Hormonal Imbalance Study
This study is trying to see if exposure to certain chemicals during pregnancy is linked to hypospadias in baby boys.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 1 Month and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, Hérault) |
| Trial ID | NCT06628375 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include biological mothers of boys aged 3 to 6 months, with one group having children diagnosed with isolated anterior or middle hypospadias and the other group having healthy children.
Not a fit: Patients who may not benefit include those with children who have complex variations of genital development or genetic syndromes.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for hypospadias by identifying harmful environmental exposures.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated a potential link between environmental factors and hypospadias, suggesting a promising area for further investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montpellier, Hérault
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.