Role of the Environment and Endocrine Disruptors in Child Cryptorchidism
ConditionCryptorchidism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age1-18
SponsorUniversity Hospital, Montpellier
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
Parent of patient with cryptorchidism
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors
Other interventionMeasure of the exposure of parent of patient with/without cryptorchidism to endocrine disruptors (job exposure, during pregnancy)
Treatment groups
1,452 Participants
are divided into 2 treatment groupsGroup A: Parent of patient with cryptorchidism1 intervention
Group B: Parent of patient without cryptorchidism1 intervention
Trial outcomes
Primary outcomes
1
frequency of the job exposure of the parents of endocrine disruptors
Measure of the frequency of endocrine disruptors assessed by european questionary QLK4-1999-01422 (simplified version )
Time frame
1 daySecondary outcomes
1
comparison of cryptorchid and non-cryptorchid children born to parents with isolated exposure vs multiple exposures
Assessement by the Job-exposure matrix EDC (Environment disrupting chemicals)
Time frame
1 day2
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.
presence of cryptorchidism at birth or secondarily
Time frame
1 day3
identify food exposure criteria (phytoestrogen or EDC pesticides) associated with the presence of a cryptorchid.
parents will be asked about their diet
Time frame
1 day4
Constitution of collection of biological samples from children with non-palpable bilateral cryptorchidism
The aim is only to make a collection of blood samples. Anonymous samples will be used later in order to improve knowledge of the cryptorchidism.
Time frame
1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Montpellier
Lead sponsor
University Hospital, Bordeaux
Collaborator
Source ClinicalTrials.gov