NCT00565513

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2002

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

First QC Date

November 29, 2007

Last Update Submit

March 26, 2026

Conditions

Cryptorchidism

Outcome Measures

Primary Outcomes (1)

  • Neonatal examination for the diagnosis of undescended testis (cryptorchidism)

    At birth, 3 and 12 month of age

Secondary Outcomes (1)

  • 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

    At birth

Study Arms (1)

A

OTHER

cord blood and maternal milk tests

Procedure: blood test

Interventions

blood testPROCEDURE

cord blood and maternal milk test

A

Eligibility Criteria

AgeUp to 1 Year
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Women having given birth to a boy at University hospital of Nice or Général hospital of Grasse

You may not qualify if:

  • parents who don't signed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Brucker-Davis F, Wagner-Mahler K, Delattre I, Ducot B, Ferrari P, Bongain A, Kurzenne JY, Mas JC, Fenichel P; Cryptorchidism Study Group from Nice Area. Cryptorchidism at birth in Nice area (France) is associated with higher prenatal exposure to PCBs and DDE, as assessed by colostrum concentrations. Hum Reprod. 2008 Aug;23(8):1708-18. doi: 10.1093/humrep/den186. Epub 2008 May 24.

    PMID: 18503055RESULT

MeSH Terms

Conditions

Cryptorchidism

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Testicular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrogenital AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Françoise BRUCKER-DAVIS, Doctor

    Department of Endocrinology of University Hospital of Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2007

First Posted

November 30, 2007

Study Start

April 1, 2002

Study Completion

April 1, 2006

Last Updated

March 31, 2026

Record last verified: 2026-03