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NCT Number: NCT04342026

Role of the Environment and Endocrine Disruptors in Child Cryptorchidism

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.

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Key information

Age range

1 month–18 year

Sex eligibility

Male

Study type

Observational

Primary location

University hospital of Montpellier

Montpellier, 34295, France

Location status: Recruiting

Location contact

nicolas KALFA, MD

CONTACT

[email protected]

334 67 33 87 84

nicolas kalfa, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors

Other

Measure of the exposure of parent of patient with/without cryptorchidism to endocrine disruptors (job exposure, during pregnancy)

Primary outcomes

  1. frequency of the job exposure of the parents of endocrine disruptors

    Time frame: 1 day

    Measure of the frequency of endocrine disruptors assessed by european questionary QLK4-1999-01422 (simplified version )

Secondary outcomes

  1. comparison of cryptorchid and non-cryptorchid children born to parents with isolated exposure vs multiple exposures

    Time frame: 1 day

    Assessement by the Job-exposure matrix EDC (Environment disrupting chemicals)

  2. 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.

    Time frame: 1 day

    presence of cryptorchidism at birth or secondarily

  3. identify food exposure criteria (phytoestrogen or EDC pesticides) associated with the presence of a cryptorchid.

    Time frame: 1 day

    parents will be asked about their diet

  4. Constitution of collection of biological samples from children with non-palpable bilateral cryptorchidism

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas KALFA, MD

CONTACT

[email protected]

00334 67 33 87 84

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • University Hospital, Bordeaux

Registry information

Acronym: CRYPTENV

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Apr 10, 2020
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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