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Recruiting NCT04342026

Role of the Environment and Endocrine Disruptors in Child Cryptorchidism

Observational Cryptorchidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors.
Who it may be relevant to
Registry conditions: Cryptorchidism. Basic parameters: 1 months — 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Cryptorchidism is the most frequent congenital defect of the male newborn. It requires surgery in childhood, increases the risk of fertility disorders and cancer. As a major public health objective, it's the subject of numerous recommendations. Its frequency is increasing in some countries faster than a single genetic cause could not explain it. It may occurs in a geographic cluster. The cause of cryptorchidism involves genetic, hormonal and environmental factors. Animal studies suggest that endocrine disruptors interfere with fetal testicular migration. The aim of the study is to find out if some environmental exposition may be associated with cryptorchidism.

Detailed description

Cryptorchidism is the most frequent congenital defect of the male newborn. It requires surgery in childhood, increases the risk of fertility disorders and cancer. As a major public health objective, it's the subject of numerous recommendations. Its frequency is increasing in some countries faster than a single genetic cause could not explain it. It may occurs in a geographic cluster. The cause of cryptorchidism involves genetic, hormonal and environmental factors. Animal studies suggest that endocrine disruptors interfere with fetal testicular migration. The aim of the study is to find out if some environmental exposition may be associated with cryptorchidism.

Interventions

  • Other Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors
    Measure of the exposure of parent of patient with/without cryptorchidism to endocrine disruptors (job exposure, during pregnancy)

Primary outcome measures

  • frequency of the job exposure of the parents of endocrine disruptors [Time frame: 1 day]
Secondary outcome measures (4)
  • comparison of cryptorchid and non-cryptorchid children born to parents with isolated exposure vs multiple exposures [Time frame: 1 day]
  • Comparison of frequencies of exposure to endocrine disruptors (Environmental Disrupting Chemicals) in parents giving birth to a congenital cryptorchid child vs child not cryptorchid at birth but with secondary cryptorchidism. [Time frame: 1 day]
  • identify food exposure criteria (phytoestrogen or EDC pesticides) associated with the presence of a cryptorchid. [Time frame: 1 day]
  • Constitution of collection of biological samples from children with non-palpable bilateral cryptorchidism [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

\- Parents of male children from the neonatal period to 18 years of age (during surgery) with cryptorchidism

Exclusion criteria

  • Parents of children without endocrine disease. (adrenal, hypothalamic-pituitary, phosphocalcic, thyroid, diabetes, etc.)
  • Parents of children without an associated genital or urinary defect (hypospadias, micropenis, renal and bladder abnormalities)
  • Testicular Ectopia (testis outside of normal migration path)
  • Anorchidism and evanescent testicles, united or bilateral
  • Abnormalities of the abdominal wall (laparoschisis, omphalocele, Prune Belly)
  • Cryptorchidism integrating in the context of a polymalformative syndrome, including neurological.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • University hospital of Montpellier — Montpellier

Identifiers

NCT: NCT04342026 · RECHMPL19_0544

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗