Tracking Fertility Changes in Young Adults With Melanoma During Treatment
Follows young adults with melanoma to see how fertility markers change during treatment.
Plain-language title generated from the registry record
Registry title: Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Key facts
- Where
- Bordeaux, Marseille, Montpellier, Nantes, Nice, Nîmes, Paris, Toulouse, and Villejuif, FranceSee the 12 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT05429138, who can take part
Where in France
- CHU de BordeauxBordeaux, FranceTaking people
- AP-HMMarseille, FranceTaking people
- Hôpital Saint JosephMarseille, FranceTaking people
- CHU MontpellierMontpellier, FranceTaking people
- CHU de NantesNantes, FranceTaking people
- CHU NICE L'archetNice, FranceTaking people
- CHRU de NîmesNîmes, FranceTaking people
- Aphp CochinParis, FranceTaking people
- APHP Saint LouisParis, FranceTaking people
- APHP- Ambroise ParéParis, FranceTaking people
- Oncôpole de ToulouseToulouse, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique Hopitaux De Marseille
- Trial code
- NCT05429138
- Record updated
- 18 November 2025
- Original description
Prospective multicentric study including women aged 18 to 37 and men aged 18 to 45 during their visit to centers for the study and storage of human sperm and eggs (CECOS). Subjects will be included before adjuvant treatment initiation (T0) and immediately after treatment (approximately 1 year after initiation, T1), and, in late post treatment (1 year after treatment cessation, T2).Read full original descriptionShow less
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Prospective multicentric study including women aged 18 to 37 and men aged 18 to 45 during their visit to centers for the study and storage of human sperm and eggs (CECOS). Subjects will be included before adjuvant treatment initiation (T0) and immediately after treatment (approximately 1 year after initiation, T1), and, in late post treatment (1 year after treatment cessation, T2).
Expected results: This study will evaluate the evolution of AMH, AFC, and semen parameters in our cohort of melanoma patients treated with anti-PD-1 and targeted therapy in an adjuvant and neoadjuvantsettings.
Inclusion: 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: 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; History of cytotoxic treatment before T0 that can alterate the studied parameters; Any condition which in the Investigator's opinion would jeopardize compliance with the protocol of the study; 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; Individuals deprived of liberty or placed under the authority of a tutor; Patients unable to understand, read and/or sign an informed consent.