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MelanomaMELpreservNCT05429138

Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma

An observational study of Melanoma, run by Assistance Publique Hopitaux De Marseille at 12 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Melanoma
What is being tested?
biological sampling
How many people
80 participants
Where
12 sitesFrance
Study dates
7 Dec 2022to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nausicaa Malissen, MD, PhD contact

0491384215

nausicaa.malissen@ap-hm.fr

DRSMR AP-HM contact

promotion.interne@ap-hm.fr

12 sites in 1 country

France12 sites, 12 recruiting

  • CHU de Bordeaux

    Bordeaux

    Caroline DUTRIAUX

    Lucie Chansel-Debordeaux

    Recruiting

  • AP-HM

    Marseille

    Nausicaa MALISSEN

    Recruiting

  • Hôpital Saint-Joseph

    Marseille

    Elodie ARCHIER

    Recruiting

  • CHU Montpellier

    Montpellier

    Vanessa Loup

    Candice Lesage

    Recruiting

  • CHU de Nantes

    Nantes

    Gaëlle QUEREUX

    Florence LEPERLIER

    Recruiting

  • CHU NICE L'archet

    Nice

    Henri MONTAUDIE

    Henri Montaudie

    Recruiting

  • CHRU de Nîmes

    Nîmes

    Pierre STOEBNER

    Recruiting

  • APHP- Ambroise Paré

    Paris

    Elisa FUNCK-BRENTANO

    Michaël GRYNBERG

    Recruiting

  • APHP-Cochin

    Paris

    Bénédicte OULES

    Virginie BARRAUD

    Recruiting

  • APHP-Saint Louis

    Paris

    Céleste LEBBE

    Barouyr BAROUDJIAN

    Recruiting

  • Oncôpole de Toulouse

    Toulouse

    Cécile PAGES

    Roger LEANDRI

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Caroline Robert

    Recruiting

Other trials in France

About this study

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.

Read the 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.

Conditions
Melanoma
Being tested
biological sampling
Keywords
melanoma, ovarian reserv, semen parameters, fertility, adjuvant
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • biological samplingOther

    Biological sampling: blood and semen

Study groups in NCT05429138
Study groupRoleWhat they receive
Immunotherapy cohortPatient that received adjuvant immunotherapy
Receives: Other: biological sampling
Targeted therapyPatient that received adjuvant targeted therapy
Receives: Other: biological sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. measurement of biological parameters : Anti-Müllerian hormone (AMH) levels in women

    change in Anti-Müllerian hormone (AMH) levels in women

    Measured: T1 (=Day0 + 12 months)

  2. measurement of biological parameters : Change in sperm motility count in men

    Change in sperm motility count per ejaculate in men

    Measured: T1 (=Day0 + 12 months)

Secondary outcomes (4)

  1. measurement of biological parameters : Antral follicle count in women

    change in antral follicle count in women

    Measured: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.

  2. measurement of biological parameters : levels of spermatozoids with sperm chromatin abnormalities

    change of rate of spermatozoids with sperm chromatin abnormalities

    Measured: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.

  3. measurement of biological parameters : Change in sperm count

    Change in sperm count (spermogram) during time

    Measured: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.

  4. measurement of biological parameters : Change in sperm motility count

    Change in sperm motility count (spermogram)

    Measured: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2022
  2. Study start7 Dec 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05429138
Sponsor's protocol ID
2021-A02601-40
Acronym
MELpreserv
Status last verified
Nov 2025
First submitted
12 May 2022
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Melanoma, run by Assistance Publique Hopitaux De Marseille at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nausicaa Malissen, MD, PhD (0491384215, nausicaa.malissen@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measurement of biological parameters : Anti-Müllerian hormone (AMH) levels in women (time frame: T1 (=Day0 + 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05429138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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