Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action
Primary Purpose
Cryptorchidism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood test
Sponsored by
About this trial
This is an interventional prevention trial for Cryptorchidism
Eligibility Criteria
Inclusion Criteria:
- Women having given birth to a boy at University hospital of Nice or Général hospital of Grasse
Exclusion Criteria:
- parents who don't signed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A
Arm Description
cord blood and maternal milk tests
Outcomes
Primary Outcome Measures
Neonatal examination for the diagnosis of undescended testis (cryptorchidism)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00565513
First Posted
November 29, 2007
Last Updated
November 29, 2007
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT00565513
Brief Title
Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action
Official Title
Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action and Multidisciplinary
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Description
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 cryptorchid vs controls: DDE 119.4 vs 80 ng/g of fat, ΣPCB 206.3 vs 166.8 ng/g of fat, mBP 17.3 vs 10.3 ng/g of milk. Cryptorchid boys were more likely to be classified in the most contaminated groups for ΣPCBs (57.1% vs 39.1% p=0.045), DDE (53.6 vs 36.2% p=0.037) and to a lesser degree mBP (58.1 vs 40%, p=0.13). This was also true for the composite score using DDE and ΣPCBs (30.4 vs 21.7%, p=0.05). Last, the odds ratio for cryptorchidism at birth was increased for the highest score of: DDE: 2.03 (p=0.05, 95%CI 0.99-4.17); ΣPCB 2.07 (p=0.046, 95%CI 1.01-4.25); composite score without phthalates 2.41 (p=0.06, 95%CI 0.96-6.1) vs the lowest score of those components.
CONCLUSIONS: The incidence of cryptorchidism at birth of 1.6% is similar to other populations. Our results support an association between fetal exposure to DDE, PCBs and possibly mBP, and the occurrence of cryptorchidism at birth. Higher concentrations in milk could be a marker of higher exposure or for an impaired detoxification pattern in genetically predisposed individuals. Long term follow up of our cohort is planned to screen cryptorchid and control boys for low sperm count, infertility and testis cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptorchidism
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
283 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
cord blood and maternal milk tests
Intervention Type
Procedure
Intervention Name(s)
blood test
Intervention Description
cord blood and maternal milk test
Primary Outcome Measure Information:
Title
Neonatal examination for the diagnosis of undescended testis (cryptorchidism)
Time Frame
At birth, 3 and 12 month of age
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women having given birth to a boy at University hospital of Nice or Général hospital of Grasse
Exclusion Criteria:
parents who don't signed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise BRUCKER-DAVIS, Doctor
Organizational Affiliation
Department of Endocrinology of University Hospital of Nice
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action
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