Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma (MELpreserv)

November 17, 2025 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To the best of our knowledge, no data is available in humans on the impact of anti-PD-1 immunotherapies and therapies targeting the MAP kinase pathway, in adjuvant settings, on ovarian reserve and semen quality.

Main objective: to measure pre-treatment (T0) and immediate post-treatment (T1) evolution of anti-Müllerian hormone (AMH) levels reflecting the ovarian reserve in women, and of the total motile sperm count per ejaculate in men, in patients of childbearing age treated with anti-PD-1 immunotherapy or targeted therapies in an adjuvant situation for melanoma at high risk of recurrence.

Method: 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).

At each of their visit to CECOS (T0, T1 and T2), the women will have an AMH assay and an antral follicle count (AFC) by ultrasound while the men will perform a semen analysis (count, spermocytogram and staining with aniline blue for analysis of chromatin condensation).

A standardized questionnaire aimed at collecting data about factors that may alter fertility will be submitted at each of these visits.

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 settings.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • CHU de Bordeaux
        • Sub-Investigator:
          • Caroline DUTRIAUX
        • Sub-Investigator:
          • Lucie Chansel-Debordeaux
      • Marseille, France
        • Recruiting
        • Höpital Saint-Joseph
        • Sub-Investigator:
          • Elodie ARCHIER
      • Marseille, France
        • Recruiting
        • AP-HM
        • Contact:
          • Nausicaa MALISSEN
      • Montpellier, France
        • Recruiting
        • CHU Montpellier
        • Contact:
          • Vanessa Loup
        • Sub-Investigator:
          • Candice Lesage
        • Sub-Investigator:
          • Vanessa Loup
        • Sub-Investigator:
          • Sophie Bringer
      • Nantes, France
        • Recruiting
        • Chu de Nantes
        • Sub-Investigator:
          • Gaëlle QUEREUX
        • Sub-Investigator:
          • Florence LEPERLIER
      • Nice, France
        • Recruiting
        • CHU NICE L'archet
        • Contact:
          • Henri MONTAUDIE
        • Sub-Investigator:
          • Henri Montaudie
        • Sub-Investigator:
          • Emmanuelle Thibault
      • Nîmes, France
        • Recruiting
        • CHRU de Nîmes
        • Sub-Investigator:
          • Pierre STOEBNER
      • Paris, France
        • Recruiting
        • APHP- Ambroise Paré
        • Sub-Investigator:
          • Elisa FUNCK-BRENTANO
        • Sub-Investigator:
          • Michaël GRYNBERG
      • Paris, France
        • Recruiting
        • APHP-Cochin
        • Sub-Investigator:
          • Bénédicte OULES
        • Sub-Investigator:
          • Virginie BARRAUD
      • Paris, France
        • Recruiting
        • APHP-Saint Louis
        • Sub-Investigator:
          • Virginie BARRAUD
        • Sub-Investigator:
          • Céleste LEBBE
        • Sub-Investigator:
          • Barouyr BAROUDJIAN
      • Toulouse, France
        • Recruiting
        • Oncôpole de Toulouse
        • Sub-Investigator:
          • Cécile PAGES
        • Sub-Investigator:
          • Roger LEANDRI
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
        • Sub-Investigator:
          • Caroline Robert

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Immunotherapy cohort
Patient that received adjuvant immunotherapy
Other: biological sampling
Biological sampling: blood and semen
Targeted therapy
Patient that received adjuvant targeted therapy
Other: biological sampling
Biological sampling: blood and semen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of biological parameters : Anti-Müllerian hormone (AMH) levels in women
Time Frame: T1 (=Day0 + 12 months)
change in Anti-Müllerian hormone (AMH) levels in women
T1 (=Day0 + 12 months)
measurement of biological parameters : Change in sperm motility count in men
Time Frame: T1 (=Day0 + 12 months)
Change in sperm motility count per ejaculate in men
T1 (=Day0 + 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of biological parameters : Antral follicle count in women
Time Frame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
change in antral follicle count in women
T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
measurement of biological parameters : levels of spermatozoids with sperm chromatin abnormalities
Time Frame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
change of rate of spermatozoids with sperm chromatin abnormalities
T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
measurement of biological parameters : Change in sperm count
Time Frame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
Change in sperm count (spermogram) during time
T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
measurement of biological parameters : Change in sperm motility count
Time Frame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
Change in sperm motility count (spermogram)
T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of biological parameters : change in sperm morphology
Time Frame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
change in sperm morphology (using spermogram)
T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Nausicaa Malissen, MD, PhD, AP-HM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02601-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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