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Could everyday chemicals raise risk of birth defect? new study investigates

NCT ID NCT06628375

Knowledge-focused Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether exposure to certain chemicals (endocrine disruptors) during pregnancy increases the chance of a baby boy being born with hypospadias, a condition where the opening of the urethra is not at the tip of the penis. Researchers will compare 100 mothers of boys with hypospadias to 100 mothers of boys without it. They will test hair samples for 150 chemicals and use questionnaires to measure overall exposure. The goal is to better understand and potentially prevent this birth defect.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify specific pollutants that raise the risk of hypospadias, leading to better prevention advice for pregnant women.
What could go wrong
This is an observational study, not a treatment trial. It can show links but not prove cause and effect. Results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Case Group: Biological mother and child with hypospadias Control group: Biological mother and child without hypospadias

Ages

1 month and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 explaining hypospadias is found during genetic analysis.

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities hypospadias

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypospadias

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CRMR DEVGEN CHU Lapeyronnie

    RECRUITING

    Montpellier, Hérault, 34090, France

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