Clinical Trial: Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action and Multidisciplinary
Brief Summary: We studied prospectively the incidence of cryptorchidism in Nice area. We tightly matched each affected child (n=95) with 2 healthy controls (n=188) and assessed risk factors for cryptorchidism focussing on prenatal exposure (cord blood and maternal milk) to endocrine disruptors known to affect testis migration, searching for correlations with cryptorchid status
Detailed Summary:
Since fetal exposure to anti-androgenic and/or estrogenic compounds is deleterious to animal reproduction, such exposure could be harmful to human fetus as well. Data are scarce on human exposure and the occurrence of cryptorchidism.
DESIGN: From 2002 to 2005, we performed a prospective case-control study to assess the incidence of cryptorchidism and fetal exposure to selected chemicals in newborn boys in Nice area. This study was approved by the ethical board of our institution. Out of 6246 live births at or after 34 weeks of gestational age and born at 2 maternity wards (University hospital of Nice and General Hospital of Grasse), 102 boys were diagnosed with cryptorchidism. After informed parental consent, 95 were included in this study, along with 188 tightly matched controls. Cord blood was collected at birth, as well as maternal milk from nursing mothers. Lifestyle and job questionnaires were filled by parents. Children were re-examined at 3 and 12 months of age to assess possible secondary testis migration, or confirm their control status.
151 cord bloods (67 cryptorchid, 84 controls) and 125 maternal milks (56 for cryptorchid boys and 69 for controls) were collected and screened for xenobiotics, including DDE, PCBs, and dibutylphthalate (and metabolite monobutylphthalate -mBP). We established scores of exposure in colostrum and studied possible relationships between exposure and cryptorchidism. We also measured hormonal status on cord blood including AMH and inhibin concentrations.
RESULTS: The incidence of cryptorchidism was 1.6% at birth, similar in Nice and Grasse, and 0.8% at 3 months of age. Xenobiotic measurements in cord blood and milk showed universal exposure in our population. Median concentrations in maternal milk were higher though not significantly in c
Sponsor: Centre Hospitalier Universitaire de Nice
Current Primary Outcome: Neonatal examination for the diagnosis of undescended testis (cryptorchidism) [ Time Frame: At birth, 3 and 12 month of age ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Measurement of xenobiotic concentrations in cord blood and maternal milk in cryptorchid and control boys Parental questionnaires: demographic information, lifestyle, job exposure Pregnancy, delivery and neonatal other information [ Time Frame: At birth ]
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire de Nice
Dates:
Date Received: November 29, 2007
Date Started: April 2002
Date Completion:
Last Updated: November 29, 2007
Last Verified: November 2007
