Clinical trial NCT04342026: Role of the Environment and Endocrine Disruptors in Child Cryptorchidism
Official title: Role of the Environment and Endocrine Disruptors in Child Cryptorchidism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cryptorchidism
Keywords: Cryptorchidism
environmental exposition
endocrine disruptors
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
First posted: 2020-04-10
Enrollment: 1200
Sex: MALE
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parent of patient with cryptorchidism

Brief summary: 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.

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.

Primary outcomes:
measure: frequency of the job exposure of the parents of endocrine disruptors
timeFrame: 1 day
Secondary outcomes:
measure: comparison of cryptorchid and non-cryptorchid children born to parents with isolated exposure vs multiple exposures
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
measure: identify food exposure criteria (phytoestrogen or EDC pesticides) associated with the presence of a cryptorchid.
timeFrame: 1 day
measure: Constitution of collection of biological samples from children with non-palpable bilateral cryptorchidism
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
References: