A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT
NCT ID: NCT06628375
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-10-03
2027-10-03
Brief Summary
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Detailed Description
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Aim. After ruling out hypospadias with a genetic cause, the aim of this study is to evaluate any significant differences to environmental endocrine disrupting-chemicals (EDCs) exposure between biological mothers of children with hypospadias and those with children without malformation. It aims to demonstrate that this exposure (professional, occupational, environmental) leads to hormonal changes during the neonatal mini-puberty period.
Methods. This research will be conducted as a multicenter case-control study: mother and son with isolated anterior or middle hypospadias (Case Group) and mother and son without hypospadias (Control Group). The clinical investigator plans to enroll 200 patients.
A single visit will be performed. This consultation is part of the usual follow-up for children in the Case Group, while it is specific to the project for children in the Control Group.
During this visit, the investigator:
* will establish the diagnosis of hypospadias (for cases) or absence of genital anomaly (for controls)
* will lead an interview using a questionnaire and a job-exposure matrix to assess EDCs during pregnancy
* will take a hair sample from the mother to measure the substances accumulated during pregnancy
* and finally, will take a blood sample from the child for hormonal evaluation of mini-puberty, and another blood sample from child in the Case Group for analysis and the participation in a DNA collection
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Case Group
Biological mother and son with hypospadias
Consultation visit (Visit 1)
During visit 1, a pediatric urologist or pediatric endocrinologist will perform a clinical examination to confirm the diagnosis of hypospadias, as a part of routine care. The clinical study investigator will ask to fill out a validated European questionnaire for the exposome and use an occupation/exposure matrix to identify specific atmospheric exposure.
A hair sample from the biological mother will be taken for toxicological evaluation of substances accumulated during pregnancy.
From the child, a blood sample will be taken for hormonal evaluation of minipuberty and then, another sample in a 5 ml EDTA tube will be taken for DNA collection.
Control Group
Biological mother and son without hypospadias
Consultation visit (Visit 1)
During visit 1, a pediatric urologist or pediatric endocrinologist will perform a clinical examination to confirm the absence of hypospadias. The clinical study investigator will ask to fill out a validated European questionnaire for the exposome and use an occupation/exposure matrix to identify specific atmospheric exposure.
A hair sample from the biological mother will be taken for toxicological evaluation of substances accumulated during pregnancy.
From the child, a blood sample will be taken for hormonal evaluation of minipuberty.
Interventions
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Consultation visit (Visit 1)
During visit 1, a pediatric urologist or pediatric endocrinologist will perform a clinical examination to confirm the diagnosis of hypospadias, as a part of routine care. The clinical study investigator will ask to fill out a validated European questionnaire for the exposome and use an occupation/exposure matrix to identify specific atmospheric exposure.
A hair sample from the biological mother will be taken for toxicological evaluation of substances accumulated during pregnancy.
From the child, a blood sample will be taken for hormonal evaluation of minipuberty and then, another sample in a 5 ml EDTA tube will be taken for DNA collection.
Consultation visit (Visit 1)
During visit 1, a pediatric urologist or pediatric endocrinologist will perform a clinical examination to confirm the absence of hypospadias. The clinical study investigator will ask to fill out a validated European questionnaire for the exposome and use an occupation/exposure matrix to identify specific atmospheric exposure.
A hair sample from the biological mother will be taken for toxicological evaluation of substances accumulated during pregnancy.
From the child, a blood sample will be taken for hormonal evaluation of minipuberty.
Eligibility Criteria
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Inclusion Criteria
* Biological mother of a boy aged between 1 and 6 months
* Biological mother with a minimum hair length of 18 cm
* Biological mother who has signed a free and informed consent for her participation
* Biological mother and child affiliated with or beneficiaries of a national health insurance plan
* Biological mother who is fluent in written and spoken French
\- The child has an isolated anterior or middle hypospadias, without any other complex variations of genital development (borderline penile size, unilateral or bilateral cryptorchidism, retractile testes), without malformation syndrome and without identified genetic etiology
\- The child must not present any complex variations in genital development (hypospadias, borderline penis size, unilateral or bilateral cryptorchidism, retractile testes)
Exclusion Criteria
* Child with an endocrine pathology
* Biological mother or child under legal protection, guardianship, or curatorship
* Biological mother or child in the exclusion period of a previous study
* Biological mother or child included in another clinical study involving a drug
Biological mother/child pairs if a genetic variant explaining hypospadias is found during genetic analysis.
1 Month
ALL
Yes
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Nicolas KALFA, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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CRMR DEVGEN CHU Lapeyronnie
Montpellier, Hérault, France
Countries
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Central Contacts
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References
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Skakkebaek NE, Rajpert-De Meyts E, Main KM. Testicular dysgenesis syndrome: an increasingly common developmental disorder with environmental aspects. Hum Reprod. 2001 May;16(5):972-8. doi: 10.1093/humrep/16.5.972.
Skarin Nordenvall A, Chen Q, Norrby C, Lundholm C, Frisen L, Nordenstrom A, Almqvist C, Nordenskjold A. Fertility in adult men born with hypospadias: A nationwide register-based cohort study on birthrates, the use of assisted reproductive technologies and infertility. Andrology. 2020 Mar;8(2):372-380. doi: 10.1111/andr.12723. Epub 2019 Nov 20.
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Asklund C, Jensen TK, Main KM, Sobotka T, Skakkebaek NE, Jorgensen N. Semen quality, reproductive hormones and fertility of men operated for hypospadias. Int J Androl. 2010 Feb;33(1):80-7. doi: 10.1111/j.1365-2605.2009.00957.x. Epub 2009 Mar 5.
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Olesen IA, Sonne SB, Hoei-Hansen CE, Rajpert-De Meyts E, Skakkebaek NE. Environment, testicular dysgenesis and carcinoma in situ testis. Best Pract Res Clin Endocrinol Metab. 2007 Sep;21(3):462-78. doi: 10.1016/j.beem.2007.04.002.
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Other Identifiers
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RECHMPL22_0559
Identifier Type: -
Identifier Source: org_study_id
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