Role of the Environment and Endocrine Disruptors in Child Cryptorchidism (CRYPTENV)

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 Overview

• Status: Recruiting
• Conditions: Cryptorchidism
• Intervention / Treatment: Other: Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors

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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • University Hospital of Montpellier
    • Principal Investigator: nicolas kalfa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Parent of patient with cryptorchidism

Description

Inclusion criteria:

- Parents of male children from the neonatal period to 18 years of age (during surgery) with cryptorchidism

Exclusion criteria:

• Parents of children without endocrine disease. (adrenal, hypothalamic-pituitary, phosphocalcic, thyroid, diabetes, etc.)
• Parents of children without an associated genital or urinary defect (hypospadias, micropenis, renal and bladder abnormalities)
• Testicular Ectopia (testis outside of normal migration path)
• Anorchidism and evanescent testicles, united or bilateral
• Abnormalities of the abdominal wall (laparoschisis, omphalocele, Prune Belly)
• Cryptorchidism integrating in the context of a polymalformative syndrome, including neurological.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parent of patient with cryptorchidism; parent exposition of endocrine disruptors	Other: Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors; Measure of the exposure of parent of patient with/without cryptorchidism to endocrine disruptors (job exposure, during pregnancy)
Parent of patient without cryptorchidism; Parent exposition of endocrine disruptors	Other: Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors; Measure of the exposure of parent of patient with/without cryptorchidism to endocrine disruptors (job exposure, during pregnancy)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of cryptorchid and non-cryptorchid children born to parents with isolated exposure vs multiple exposures	Assessement by the Job-exposure matrix EDC (Environment disrupting chemicals)	1 day
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.	presence of cryptorchidism at birth or secondarily	1 day
identify food exposure criteria (phytoestrogen or EDC pesticides) associated with the presence of a cryptorchid.	parents will be asked about their diet	1 day
Constitution of collection of biological samples from children with non-palpable bilateral cryptorchidism	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.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Anticipated): October 16, 2023
• Study Completion (Anticipated): April 16, 2024

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cryptorchidism; environmental exposition; endocrine disruptors
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Urogenital Abnormalities; Congenital Abnormalities; Testicular Diseases; Cryptorchidism; Physiological Effects of Drugs; Endocrine Disruptors
• Other Study ID Numbers: RECHMPL19-0544

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No