Actively Recruiting

Age: 1Month +
All Genders
Healthy Volunteers
ID06628375

Exposure to Endocrine Disruptors and Occurrence of Hypospadias: Toxicological, Environmental and Hormonal Imbalance Study

Led by University Hospital, Montpellier · Updated on 2025-11-26

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the impact of exposure to Endocrine-Disrupting Chemicals (EDCs) on the risk of hypospadias, a common birth defect affecting the external genital organs in boys. This multicenter case-control study compares biological mothers of boys with hypospadias (Case Group) to mothers of boys without malformations (Control Group) to better understand environmental and hormonal factors that might contribute to this condition. The study aims to clarify how exposure to these chemicals during pregnancy might influence hormonal changes in newborns. The study involves a single consultation visit where a pediatric urologist or endocrinologist will confirm the presence or absence of hypospadias. Mothers will complete a validated European questionnaire and an occupation/exposure matrix to assess environmental and occupational exposure to EDCs during pregnancy. Hair samples will be collected from mothers to analyze accumulated toxic substances, and blood samples will be taken from the children to evaluate hormone levels during the neonatal mini-puberty period. For cases, an additional blood sample will be collected for DNA analysis. Participants will attend one visit where clinical examinations, interviews, and sample collections occur. Researchers will measure toxic exposures through hair analysis, assess environmental exposures using questionnaires and models, and evaluate hormonal levels in the children. The study will help improve understanding and prevention of hypospadias by linking environmental exposures and hormonal changes. The total participation involves this single visit, with careful monitoring and data collection during that time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Month +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Parents of legal age who have signed informed consent for their child's participation
  • 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 informed consent for her own participation
  • Biological mother and child covered by a national health insurance plan
  • Biological mother fluent in written and spoken French
  • For Case Group: child has isolated anterior or middle hypospadias without other complex genital variations, malformation syndromes, or known genetic causes
  • For Control Group: child has no complex genital development variations such as hypospadias or cryptorchidism
Not Eligible

You will not qualify if you...

  • Child with other congenital anomalies or malformation syndromes
  • Child with endocrine diseases
  • Biological mother or child under legal protection, guardianship, or curatorship
  • Biological mother or child currently in exclusion period from another study
  • Biological mother or child participating in another clinical study involving a drug
  • For Case Group: pairs where a genetic variant explaining hypospadias is found during genetic analysis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Consultation Visit

Duration - 1 day

Participants attend a single consultation visit where a pediatric specialist confirms diagnosis status, collects questionnaire data on environmental exposures, and obtains biological samples including hair from the mother and blood from the child for toxicological, hormonal, and genetic analyses.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

CRMR DEVGEN CHU Lapeyronnie

Montpellier, Hérault, France, 34090

Actively Recruiting

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Research Team

N

Nicolas KALFA, Prof

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

How Far Should We Explore Hypospadias? Next-generation Sequencing Applied to a Large Cohort of Hypospadiac Patients.

Vuthy Ea, Anne Bergougnoux, Pascal Philibert...

https://pubmed.ncbi.nlm.nih.gov/33468338

Fertility in adult men born with hypospadias: A nationwide register-based cohort study on birthrates, the use of assisted reproductive technologies and infertility.

Anna Skarin Nordenvall, Qi Chen, Christina Norrby...

https://pubmed.ncbi.nlm.nih.gov/31670475

Association between male genital anomalies and adult male reproductive disorders: a population-based data linkage study spanning more than 40 years.

Francisco J Schneuer, Elizabeth Milne, Sarra E Jamieson...

https://pubmed.ncbi.nlm.nih.gov/30236382

Cryptorchidism: aspects of fertility and neoplasms. A study including data of 1,335 consecutive boys who underwent testicular biopsy simultaneously with surgery for cryptorchidism.

D Cortes, J M Thorup, J Visfeldt

https://pubmed.ncbi.nlm.nih.gov/11423738