Studies how melanoma treatments after surgery may affect fertility in women
Follows women of childbearing age with melanoma who receive treatments after surgery.
Plain-language title generated from the registry record
Registry title: MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.
Key facts
- Where
- Bari, Genova, Milan, Modena, Naples, Padova, Perugia, Roma, Siena, and Torino, ItalySee the 10 sites
Where in Italy
- Ospedale Oncologico "Giovanni Paolo II"Bari, ItalyNot yet recruiting
- IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2Genova, ItalyNot yet recruiting
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria ModenaModena, ItalyNot yet recruiting
- Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyNot yet recruiting
- IOV Istituto Oncologico VenetoPadova, ItalyNot yet recruiting
- Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.Perugia, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyNot yet recruiting
- Università degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria SeneseSiena, ItalyNot yet recruiting
- Università di Torino - Clinica DermatologicaTorino, ItalyNot yet recruiting
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
- Intergruppo Melanoma Italiano
- Trial code
- NCT07092670
- Record updated
- 5 September 2025
- Original description
Melanoma survivorship in reproductive-age women is increasing due to the advent of effective therapies in the curative setting. However, while the impact on fertility and ovarian function of chemotherapy agents is well known, there is still a lack of consistent data regarding novel the Mitogen-activated protein kinase (MAP) kinase pathway inhibitors and immune-checkpoint inhibitors (ICIs) used in melanoma.Read full original descriptionShow less
MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study
Melanoma survivorship in reproductive-age women is increasing due to the advent of effective therapies in the curative setting. However, while the impact on fertility and ovarian function of chemotherapy agents is well known, there is still a lack of consistent data regarding novel the Mitogen-activated protein kinase (MAP) kinase pathway inhibitors and immune-checkpoint inhibitors (ICIs) used in melanoma.
A recent study showed that a single course of anti-PD-1 (PD, Programmed cell death protein 1) or anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) reduced both the number and quality of oocytes in mice through an immune-mediated mechanism. In particular, primordial follicle damage cannot be restored, leading to relevant clinical implications.
The study aims to help to determine the impact of MAP kinase pathway inhibitors and ICIs on reproductive outcomes, and whether clinicians should discuss (and in what terms) fertility preservation techniques in reproductive-age women receiving ICIs and MAP kinase pathway inhibitors in the adjuvant setting.
Inclusion: Stage II, III, IV completely resected melanoma; Female sex; Under 40 years of age; Not previously treated with chemotherapy and/or radiotherapy; Being able to give written informed consent.
Exclusion: Previous bilateral ovariectomy or other ovarian surgery; Predisposing conditions for infertility; Personal history of autoimmune diseases, endocrine disorders (except for hypothyroidism); Personal history of severe mental disorders associated with infertility (e.g., nervous anorexia) and/or requiring treatments that could impair fertility; Early menopause or family history of early ovarian failure (idiopathic, < 45 years); Unresectable melanoma; Inability to give written informed consent.