NCT04342026

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,452

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Apr 2020Apr 2028

First Submitted

Initial submission to the registry

March 20, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

April 16, 2020

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2028

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

7.5 years

First QC Date

March 20, 2020

Last Update Submit

September 29, 2025

Conditions

Cryptorchidism

Keywords

Cryptorchidismenvironmental expositionendocrine disruptors

Outcome Measures

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 )

    1 day

Secondary Outcomes (4)

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

    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.

    1 day

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

    1 day

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

    1 day

Study Arms (2)

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

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

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

Parent of patient with cryptorchidismParent of patient without cryptorchidism

Eligibility Criteria

Age1 Month - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Parent of patient with cryptorchidism

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Cryptorchidism

Condition Hierarchy (Ancestors)

Testicular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrogenital AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System Diseases

Central Study Contacts

Nicolas KALFA, MD

CONTACT

00334 67 33 87 84n-kalfa@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2020

First Posted

April 10, 2020

Study Start

April 16, 2020

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

April 15, 2028

Last Updated

October 3, 2025

Record last verified: 2025-09

Locations

FR(1)