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Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565513
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : November 30, 2007
Information provided by:
Centre Hospitalier Universitaire de Nice

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

Condition or disease Intervention/treatment Phase
Cryptorchidism Procedure: blood test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action and Multidisciplinary
Study Start Date : April 2002
Actual Study Completion Date : April 2006

Arm Intervention/treatment
cord blood and maternal milk tests
Procedure: blood test
cord blood and maternal milk test

Primary Outcome Measures :
  1. Neonatal examination for the diagnosis of undescended testis (cryptorchidism) [ Time Frame: At birth, 3 and 12 month of age ]

Secondary Outcome Measures :
  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 [ Time Frame: At birth ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00565513

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Principal Investigator: Françoise BRUCKER-DAVIS, Doctor Department of Endocrinology of University Hospital of Nice

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Responsible Party: Cynthia GIRAN, Département de la Recherche Clinique et de l'Innovation Identifier: NCT00565513    
Other Study ID Numbers: PHRC 2001
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: November 2007
Additional relevant MeSH terms:
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Testicular Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases