Role of the Environment and Endocrine Disruptors in Child Cryptorchidism

Recruiting

• Conditions: Cryptorchidism
• Interventions: Other: Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors

• Registration Number: NCT04342026
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Cryptorchidism is the most frequent congenital defect of the male newborn. It requires surgery in childhood, increases the risk of fertility disorders and cancer. As a major public health objective, it's the subject of numerous recommendations. Its frequency is increasing in some countries faster than a single genetic cause could not explain it. It may occurs in a geographic cluster. The cause of cryptorchidism involves genetic, hormonal and environmental factors. Animal studies suggest that endocrine disruptors interfere with fetal testicular migration. The aim of the study is to find out if some environmental exposition may be associated with cryptorchidism.

Detailed Description

Cryptorchidism is the most frequent congenital defect of the male newborn. It requires surgery in childhood, increases the risk of fertility disorders and cancer. As a major public health objective, it's the subject of numerous recommendations. Its frequency is increasing in some countries faster than a single genetic cause could not explain it. It may occurs in a geographic cluster. The cause of cryptorchidism involves genetic, hormonal and environmental factors. Animal studies suggest that endocrine disruptors interfere with fetal testicular migration. The aim of the study is to find out if some environmental exposition may be associated with cryptorchidism.

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-10
• Study Start: 2020-04-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-10-15
• Study Completion: 2026-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parent of patient with cryptorchidism	Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors	parent exposition of endocrine disruptors
Parent of patient without cryptorchidism	Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors	Parent exposition of endocrine disruptors

Primary Outcome Measures

Name	Time	Method
frequency of the job exposure of the parents of endocrine disruptors	1 day	Measure of the frequency of endocrine disruptors assessed by european questionary QLK4-1999-01422 (simplified version )

Secondary Outcome Measures

Name	Time	Method
identify food exposure criteria (phytoestrogen or EDC pesticides) associated with the presence of a cryptorchid.	1 day	parents will be asked about their diet
Constitution of collection of biological samples from children with non-palpable bilateral cryptorchidism	1 day	The aim is only to make a collection of blood samples. Anonymous samples will be used later in order to improve knowledge of the cryptorchidism.
comparison of cryptorchid and non-cryptorchid children born to parents with isolated exposure vs multiple exposures	1 day	Assessement by the Job-exposure matrix EDC (Environment disrupting chemicals)
Comparison of frequencies of exposure to endocrine disruptors (Environmental Disrupting Chemicals) in parents giving birth to a congenital cryptorchid child vs child not cryptorchid at birth but with secondary cryptorchidism.	1 day	presence of cryptorchidism at birth or secondarily

Trial Locations

Locations (1)

University hospital of Montpellier; 🇫🇷 Montpellier, France