CryptorchidismCRYPTENVNCT04342026
Role of the Environment and Endocrine Disruptors in Child Cryptorchidism
An observational study of Cryptorchidism, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years, men only
- Conditions the study is for
- Cryptorchidism
- What is being tested?
- Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors
- How many people
- 1,452 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2020to 15 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Parent of patient with cryptorchidism
Who may be able to join
- Parents of male children from the neonatal period to 18 years of age (during surgery) with cryptorchidism
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University hospital of Montpellier
Montpellier, 34295
nicolas KALFA, MD, 334 67 33 87 84, n-kalfa@chu-montpellier.fr
nicolas kalfa, MD
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.
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.
- Conditions
- Cryptorchidism
- Being tested
- Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors
- Keywords
- Cryptorchidism, environmental exposition, endocrine disruptors
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Parent of patient with cryptorchidism | parent exposition of endocrine disruptors Receives: 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 Receives: Other: Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 1 day
Secondary outcomes (4)
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)
Measured: 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
Measured: 1 day
identify food exposure criteria (phytoestrogen or EDC pesticides) associated with the presence of a cryptorchid.
parents will be asked about their diet
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start16 Apr 2020
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryptorchidismStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342026
- Sponsor's protocol ID
- RECHMPL19_0544
- Acronym
- CRYPTENV
- Status last verified
- Sep 2025
- First submitted
- 20 Mar 2020
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Environment and Endocrine Disruptors in Child Cryptorchidism
- ClinicalTrials.gov ID
- NCT04342026
- Acronym / sponsor ID
- CRYPTENV / RECHMPL19_0544
- Conditions
- Cryptorchidism
- Keywords
- Cryptorchidism, environmental exposition, endocrine disruptors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,452 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent of patient with cryptorchidism | – | Other: Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptorsparent exposition of endocrine disruptors |
| Parent of patient without cryptorchidism | – | Other: Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptorsParent exposition of endocrine disruptors |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Parent of patient with cryptorchidism
Key inclusion criteria (1 listed)
- Parents of male children from the neonatal period to 18 years of age (during surgery) with cryptorchidism
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptorsMeasure of the exposure of parent of patient with/without cryptorchidism to endocrine disruptors (job exposure, during pregnancy) | Other | Parent of patient with cryptorchidism, Parent of patient without cryptorchidism |
Primary outcome
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 )
4 secondary outcomes
comparison of cryptorchid and non-cryptorchid children born to parents with isolated exposure vs multiple exposures
Time frame: 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.
Time frame: 1 day
identify food exposure criteria (phytoestrogen or EDC pesticides) associated with the presence of a cryptorchid.
Time frame: 1 day
Constitution of collection of biological samples from children with non-palpable bilateral cryptorchidism
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptorchidism, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas KALFA, MD (00334 67 33 87 84, n-kalfa@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of the job exposure of the parents of endocrine disruptors (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.