A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of… (NCT06628375) | Clinical Trial Compass
RecruitingNot Applicable
A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT
France200 participantsStarted 2024-10-03
Plain-language summary
This study aims to demonstrate the impact of Endocrine-Disrupting Chemicals (EDCs) on the risk of hypospadias incidence. It is a multicenter comparative case-control study, involving two groups. The first group consists of biological mothers who have given birth to children with hypospadias (Case Group), while the second group consists of biological mothers who have given birth to children without any malformations (Control Group). Through an integrative approach that combines a direct toxicological study of numerous pollutants present during pregnancy, and a comprehensive exposome assessment using validated tools, this study can significantly enhance our understanding and prevention of this malformation.
Who can participate
Age range
1 Month
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Non-specific Inclusion Criteria :
* Parents of legal age having signed a free and informed consent for the participation of their child
* 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
Specific Inclusion Criteria for Case Group:
\- 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
Specific Inclusion Criteria for Control Group:
\- 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 another congenital anomaly or malformative syndrome
* 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
Specific Exclusion Criteria for Case Group:
Biological mother/child pairs if a genetic variant expl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of toxic exposure via hair sample analysis