Melanoma therapy may impact fertility – new study investigates
NCT ID NCT05429138
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tracks fertility markers in 80 melanoma patients (women aged 18-37, men aged 18-45) before, during, and after adjuvant therapy with anti-PD-1 or targeted treatments. Researchers measure hormone levels in women and sperm quality in men to see how these change over time. The goal is to better understand the effects of modern melanoma treatments on reproductive health.
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 study could help doctors understand how melanoma treatments impact fertility, guiding future family planning advice for patients.
- What could go wrong
- This is an observational study, not a treatment trial. It only measures changes and does not test any new therapy or intervention.
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
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
Patients of childbearing age treated with an adjuvant anti-PD-1 immunotherapy or neoadjuvant plus adjuvant or targeted therapies for a melanoma at high risk of recurrence
- Ages
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18 to 45 years
- Sex
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Anyone
Show the full entry requirements Hide 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.
Inclusion Criteria: * Patients must have provided a signed, dated and written consent prior to any specific procedures, sampling and analyses * Patients with valide Health Inssurance Scheme * Female between 18 and 37 years old and male between 18 and 45 years old * During the 2 months before the introduction of an approved regimen of adjuvant anti-PD-1 immunotherapy or neoadjuvant plus adjuvant or targeted therapy for an high-risk of reccurence melanoma * Adjuvant or neoadjuvant plus adjuvant treatment must be prescribed as part of routine care Exclusion Criteria: * Individuals deprived of liberty or placed under the authority of a tutor * Patients unable to understand, read and/or sign an informed consent * History of cytotoxic treatment before T0 that can alterate the studied parameters * In male, totale motile sperm count per ejaculate inferior to 39 millions at T0 * In women, an age-specific AMH level inferior to the 10th percentile at T0 * Any condition which in the Investigator's opinion would jeopardize compliance with the protocol of the study * Patients that will received an investigational treatment during the study timeframe (an observational research is allowed) * Patients who have changed the type of adjuvant treatment during adjuvant treatment (targeted switch therapy versus targeted immunotherapy and vice versa) or after the neoadjuvant phase due to the pathological response obtained.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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AP-HM
RECRUITINGMarseille, France
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APHP- Ambroise Paré
RECRUITINGParis, France
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APHP-Cochin
RECRUITINGParis, France
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APHP-Saint Louis
RECRUITINGParis, France
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CHRU de Nîmes
RECRUITINGNîmes, France
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CHU Montpellier
RECRUITINGMontpellier, France
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CHU NICE L'archet
RECRUITINGNice, France
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CHU de Bordeaux
RECRUITINGBordeaux, France
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CHU de Nantes
RECRUITINGNantes, France
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Hôpital Saint-Joseph
RECRUITINGMarseille, France
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Institut Gustave Roussy
RECRUITINGVillejuif, France
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Oncôpole de Toulouse
RECRUITINGToulouse, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody GNR-051 tested for safety in Hard-to-Treat cancers
- Blood test could spot Melanoma's BRAF mutation
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?
- Can a Two-Drug immune combo shrink melanoma tumors?