|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00565513 |
|
Date of registration:
|
29/11/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action
|
|
Scientific title:
|
Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action and Multidisciplinary |
|
Date of first enrolment:
|
April 2002 |
|
Target sample size:
|
283 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00565513 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
|
Contacts
|
|
Name:
|
Françoise BRUCKER-DAVIS, Doctor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Endocrinology of University Hospital of Nice |
| | |
|
Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
1 Year
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Cryptorchidism
|
|
Intervention(s)
|
|
Procedure: blood test
|
|
Primary Outcome(s)
|
|
Neonatal examination for the diagnosis of undescended testis (cryptorchidism)
[Time Frame: At birth, 3 and 12 month of age]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Secondary ID(s)
|
|
PHRC 2001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|