Hypospadias Clinical Trial
Official title:
Case-control Study of the Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie
We want to see if there is a relationship between exposure to pesticides and the occurrence of hypospade in Picard newborn .
Hypospadias is the most frequent malformation of the external genital organs in the male
infant. Incomplete virilization of the genital bud results in hypoplasia of the tissues on
the ventral aspect of the penis, with an ectopic ureteral meatus, a curved penile shaft and
an incompletely formed foreskin. The condition is generally isolated and the aetiology is
unknown. The pathogenesis is complex and involves hormonal, genetic and environmental factors
(which are probably interlinked).
A doubling in the incidence of hypospadias over the last 15 years has emphasized the probable
role of environment factors: in fact, certain exogenous compounds (collectively referred to
as "endocrine disruptors" (EDs)) may modify hormonal functions and thus exert harmful effects
on the organism or its offspring.
The male urethra develops between the 8th and 16th weeks of gestation in an
androgen-dependence manner. In utero exposure of the foetus to EDs may have a
physiopathological role in the abnormal development of the male genital bud and thus in the
development of hypospadia. These EDs are present in many different substances, such as
pesticides.
Many epidemiological studies have evidenced an increase in the incidence of hypospadias in
children born to exposed parents. Furthermore, animal studies have identified a certain
number of compounds associated with hypospadias after in utero exposure. However, human
foetal samples have very rarely been assayed in an attempt to measure the true level of
impregnation (i.e. the dose received). At present, it is not possible to draw firm
conclusions with regard to the true extent of a link between EDs and the increased incidence
of hypospadia.
The "HypoMeco" project is a prospective case-control study.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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Phase 3 | |
| Active, not recruiting |
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Phase 4 | |
| Terminated |
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| Recruiting |
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Phase 4 | |
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