NCT05429138Recruiting
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 12 May 2022
- Start date
- 7 Dec 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Diseases
- Melanoma, Ovarian cancer
- NCT number
- NCT05429138
What you commit to
- Study type: Observational
- Planned participants: 80
- From 7 Dec 2022 to the primary completion date, Dec 2026
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- In male, totale motile sperm count per ejaculate inferior to 39 millions at T0
Age
- In women, an age-specific AMH level inferior to the 10th percentile at T0
Other
- Individuals deprived of liberty or placed under the authority of a tutor
- Patients unable to understand, read and/or sign an informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.