Role of the Environment and Endocrine Disruptors in Child Cryptorchidism

Cryptorchidism Clinical Trial

— CRYPTENV  

Official title:

Role of the Environment and Endocrine Disruptors in Child Cryptorchidism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04342026
• Other study ID #: RECHMPL19-0544
• Status: Recruiting
• Start date: April 16, 2020
• Est. completion date: October 15, 2026

Study information

• Verified date: November 2023
• Source: University Hospital, Montpellier
• Contact: Nicolas KALFA, MD
• Phone: 00334 67 33 87 84
• Email: n-kalfa[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 15, 2026
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cryptorchidism

Intervention

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)

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	identify food exposure criteria (phytoestrogen or EDC pesticides) associated with the presence of a cryptorchid.	parents will be asked about their diet	1 day
Secondary	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