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RecruitingNCT04342026CRYPTENVUpdated Oct 3, 2025

Role of the Environment and Endocrine Disruptors in Child Cryptorchidism

An observational study in Cryptorchidism, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to male participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by University Hospital, Montpellier · Observational

From the registry’s dates

  • Started Apr 2020; still recruiting 6 years 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,452
Ages
1 Month to 18 Years
Sex
Male
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Study 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.

Read the 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.

02

Conditions studied

  • Cryptorchidism

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Keywords

  • Cryptorchidism
  • environmental exposition
  • endocrine disruptors
03

In context

Cryptorchidism

40 studies on the registry are indexed under Cryptorchidism; 14 are open to participants now.

This study's planned enrollment of 1,452 is above the median of 100 across 14 observational studies indexed under Cryptorchidism.

Browse Cryptorchidism studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Parent of patient with cryptorchidism

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,452 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • OtherMeasure 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)

06

What researchers measure

Primary outcomes

  1. 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 )

    Time frame: 1 day

Secondary outcomes

  1. 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)

    Time frame: 1 day

  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.

    presence of cryptorchidism at birth or secondarily

    Time frame: 1 day

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

    parents will be asked about their diet

    Time frame: 1 day

  4. 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.

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04342026
Responsible party
Sponsor
First posted
Apr 10, 2020
Start date
Apr 16, 2020
Primary completion
Oct 15, 2027 (estimated)
Completion
Apr 15, 2028 (estimated)
Last update
Oct 3, 2025

Study contacts

Nicolas KALFA, MD
Contact
n-kalfa@chu-montpellier.fr
00334 67 33 87 84

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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