CryptorchidismNCT00565513
Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action
A study testing blood test in people with Cryptorchidism, run by Centre Hospitalier Universitaire de Nice.
Trial summary
We studied prospectively the incidence of cryptorchidism in Nice area. We tightly matched each affected child (n=95) with 2 healthy controls (n=188) and assessed risk factors for cryptorchidism focussing on prenatal exposure (cord blood and maternal milk) to endocrine disruptors known to affect testis migration… Read more about this study
- Who is it for?
- Ages Up to 1 year, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cryptorchidism
- What is being tested?
- blood test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 1 year
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Women having given birth to a boy at University hospital of Nice or Général hospital of Grasse
Who cannot join
- parents who don't signed consent
About this study
Official title: Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action and Multidisciplinary
We studied prospectively the incidence of cryptorchidism in Nice area. We tightly matched each affected child (n=95) with 2 healthy controls (n=188) and assessed risk factors for cryptorchidism focussing on prenatal exposure (cord blood and maternal milk) to endocrine disruptors known to affect testis migration, searching for correlations with cryptorchid status
Read the detailed description
Since fetal exposure to anti-androgenic and/or estrogenic compounds is deleterious to animal reproduction, such exposure could be harmful to human fetus as well. Data are scarce on human exposure and the occurrence of cryptorchidism.
DESIGN: From 2002 to 2005, we performed a prospective case-control study to assess the incidence of cryptorchidism and fetal exposure to selected chemicals in newborn boys in Nice area. This study was approved by the ethical board of our institution. Out of 6246 live births at or after 34 weeks of gestational age and born at 2 maternity wards (University hospital of Nice and General Hospital of Grasse), 102 boys were diagnosed with cryptorchidism. After informed parental consent, 95 were included in this study, along with 188 tightly matched controls. Cord blood was collected at birth, as well as maternal milk from nursing mothers. Lifestyle and job questionnaires were filled by parents. Children were re-examined at 3 and 12 months of age to assess possible secondary testis migration, or confirm their control status.
151 cord bloods (67 cryptorchid, 84 controls) and 125 maternal milks (56 for cryptorchid boys and 69 for controls) were collected and screened for xenobiotics, including DDE, PCBs, and dibutylphthalate (and metabolite monobutylphthalate -mBP). We established scores of exposure in colostrum and studied possible relationships between exposure and cryptorchidism. We also measured hormonal status on cord blood including AMH and inhibin concentrations.
RESULTS: The incidence of cryptorchidism was 1.6% at birth, similar in Nice and Grasse, and 0.8% at 3 months of age. Xenobiotic measurements in cord blood and milk showed universal exposure in our population. Median concentrations in maternal milk were higher though not significantly in cryptorchid vs controls: DDE 119.4 vs 80 ng/g of fat, ΣPCB 206.3 vs 166.8 ng/g of fat, mBP 17.3 vs 10.3 ng/g of milk. Cryptorchid boys were more likely to be classified in the most contaminated groups for ΣPCBs (57.1% vs 39.1% p=0.045), DDE (53.6 vs 36.2% p=0.037) and to a lesser degree mBP (58.1 vs 40%, p=0.13). This was also true for the composite score using DDE and ΣPCBs (30.4 vs 21.7%, p=0.05). Last, the odds ratio for cryptorchidism at birth was increased for the highest score of: DDE: 2.03 (p=0.05, 95%CI 0.99-4.17); ΣPCB 2.07 (p=0.046, 95%CI 1.01-4.25); composite score without phthalates 2.41 (p=0.06, 95%CI 0.96-6.1) vs the lowest score of those components.
CONCLUSIONS: The incidence of cryptorchidism at birth of 1.6% is similar to other populations. Our results support an association between fetal exposure to DDE, PCBs and possibly mBP, and the occurrence of cryptorchidism at birth. Higher concentrations in milk could be a marker of higher exposure or for an impaired detoxification pattern in genetically predisposed individuals. Long term follow up of our cohort is planned to screen cryptorchid and control boys for low sperm count, infertility and testis cancer.
- Conditions
- Cryptorchidism
- Being tested
- blood test
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testProcedure or surgery
cord blood and maternal milk test
| Study group | Role | What they receive |
|---|---|---|
| A | Other | cord blood and maternal milk tests Receives: Procedure: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal examination for the diagnosis of undescended testis (cryptorchidism)
Measured: At birth, 3 and 12 month of age
Secondary outcomes (1)
Measurement of xenobiotic concentrations in cord blood and maternal milk in cryptorchid and control boys Parental questionnaires: demographic information, lifestyle, job exposure Pregnancy, delivery and neonatal other information
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startApr 2002
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CryptorchidismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Françoise BRUCKER-DAVIS, Doctor, Principal investigator, Department of Endocrinology of University Hospital of Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565513
- Sponsor's protocol ID
- PHRC 2001
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2007
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Brucker-Davis F, Wagner-Mahler K, Delattre I, Ducot B, Ferrari P, Bongain A, Kurzenne JY, Mas JC, Fenichel P; Cryptorchidism Study Group from Nice Area. Cryptorchidism at birth in Nice area (France) is associated with higher prenatal exposure to PCBs and DDE, as assessed by colostrum concentrations. Hum Reprod. 2008 Aug;23(8):1708-18. doi: 10.1093/humrep/den186. Epub 2008 May 24.
PubMed 18503055
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryptorchidism: Impact of in Utero Exposure to Xenobiotics With Hormonal Action and Multidisciplinary
- ClinicalTrials.gov ID
- NCT00565513
- Acronym / sponsor ID
- PHRC 2001
- Conditions
- Cryptorchidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Apr 2006 (actual)
- First posted
- 30 Nov 2007 (estimated)
- 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.
We studied prospectively the incidence of cryptorchidism in Nice area. We tightly matched each affected child (n=95) with 2 healthy controls (n=188) and assessed risk factors for cryptorchidism focussing on prenatal exposure (cord blood and maternal milk) to endocrine disruptors known to affect testis migration, searching for correlations with cryptorchid status
Detailed description
Since fetal exposure to anti-androgenic and/or estrogenic compounds is deleterious to animal reproduction, such exposure could be harmful to human fetus as well. Data are scarce on human exposure and the occurrence of cryptorchidism.
DESIGN: From 2002 to 2005, we performed a prospective case-control study to assess the incidence of cryptorchidism and fetal exposure to selected chemicals in newborn boys in Nice area. This study was approved by the ethical board of our institution. Out of 6246 live births at or after 34 weeks of gestational age and born at 2 maternity wards (University hospital of Nice and General Hospital of Grasse), 102 boys were diagnosed with cryptorchidism. After informed parental consent, 95 were included in this study, along with 188 tightly matched controls. Cord blood was collected at birth, as well as maternal milk from nursing mothers. Lifestyle and job questionnaires were filled by parents. Children were re-examined at 3 and 12 months of age to assess possible secondary testis migration, or confirm their control status.
151 cord bloods (67 cryptorchid, 84 controls) and 125 maternal milks (56 for cryptorchid boys and 69 for controls) were collected and screened for xenobiotics, including DDE, PCBs, and dibutylphthalate (and metabolite monobutylphthalate -mBP). We established scores of exposure in colostrum and studied possible relationships between exposure and cryptorchidism. We also measured hormonal status on cord blood including AMH and inhibin concentrations.
RESULTS: The incidence of cryptorchidism was 1.6% at birth, similar in Nice and Grasse, and 0.8% at 3 months of age. Xenobiotic measurements in cord blood and milk showed universal exposure in our population. Median concentrations in maternal milk were higher though not significantly in cryptorchid vs controls: DDE 119.4 vs 80 ng/g of fat, ΣPCB 206.3 vs 166.8 ng/g of fat, mBP 17.3 vs 10.3 ng/g of milk. Cryptorchid boys were more likely to be classified in the most contaminated groups for ΣPCBs (57.1% vs 39.1% p=0.045), DDE (53.6 vs 36.2% p=0.037) and to a lesser degree mBP (58.1 vs 40%, p=0.13). This was also true for the composite score using DDE and ΣPCBs (30.4 vs 21.7%, p=0.05). Last, the odds ratio for cryptorchidism at birth was increased for the highest score of: DDE: 2.03 (p=0.05, 95%CI 0.99-4.17); ΣPCB 2.07 (p=0.046, 95%CI 1.01-4.25); composite score without phthalates 2.41 (p=0.06, 95%CI 0.96-6.1) vs the lowest score of those components.
CONCLUSIONS: The incidence of cryptorchidism at birth of 1.6% is similar to other populations. Our results support an association between fetal exposure to DDE, PCBs and possibly mBP, and the occurrence of cryptorchidism at birth. Higher concentrations in milk could be a marker of higher exposure or for an impaired detoxification pattern in genetically predisposed individuals. Long term follow up of our cohort is planned to screen cryptorchid and control boys for low sperm count, infertility and testis cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: blood testcord blood and maternal milk tests |
Who may qualify
- Ages
- Up to 1 year
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Women having given birth to a boy at University hospital of Nice or Général hospital of Grasse
Key exclusion criteria (1 listed)
- parents who don't signed consent
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 |
|---|---|---|
| blood testcord blood and maternal milk test | Procedure or surgery | A |
Primary outcome
Neonatal examination for the diagnosis of undescended testis (cryptorchidism)
Time frame: At birth, 3 and 12 month of age
1 secondary outcome
Measurement of xenobiotic concentrations in cord blood and maternal milk in cryptorchid and control boys Parental questionnaires: demographic information, lifestyle, job exposure Pregnancy, delivery and neonatal other information
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Results publication: PubMed 18503055Brucker-Davis F, Wagner-Mahler K, Delattre I, Ducot B, Ferrari P, Bongain A, Kurzenne JY, Mas JC, Fenichel P; Cryptorchidism Study Group from Nice Area. Cryptorchidism at birth in Nice area (France) is associated with higher prenatal exposure to PCBs and DDE, as assessed by colostrum concentrations. Hum Reprod. 2008 Aug;23(8):1708-18. doi: 10.1093/humrep/den186. Epub 2008 May 24.
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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. This study is not recruiting at the moment.
Françoise BRUCKER-DAVIS, Doctor principal investigator
Department of Endocrinology of University Hospital of Nice
Questions about this trial
What is this clinical trial studying?
A study testing blood test in people with Cryptorchidism, run by Centre Hospitalier Universitaire de Nice.
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 1 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: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal examination for the diagnosis of undescended testis (cryptorchidism) (time frame: At birth, 3 and 12 month of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00565513, which also lists 1 linked publication.
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 31 Mar 2026.