Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma

Melanoma Clinical Trial

— MELpreserv  

Official title:

Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429138
• Other study ID #: 2021-A02601-40
• Status: Recruiting
• Start date: December 7, 2022
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Rawand Masoud, PhD
• Phone: 04 91 38 16 77
• Email: rawand.masoud[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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), 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• biological sampling
Biological sampling: blood and semen

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	AP-HM	Marseille
France	Hôpital Saint-Joseph	Marseille
France	CHU Montpellier	Montpellier
France	CHU de Nantes	Nantes
France	CHU NICE L'archet	Nice
France	CHRU de Nîmes	Nîmes
France	APHP- Ambroise Paré	Paris
France	APHP-Cochin	Paris
France	APHP-Saint Louis	Paris
France	Oncôpole de Toulouse	Toulouse
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	measurement of biological parameters : change in sperm morphology	change in sperm morphology (using spermogram)	T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
Primary	measurement of biological parameters : Anti-Müllerian hormone (AMH) levels in women	change in Anti-Müllerian hormone (AMH) levels in women	T1 (=Day0 + 12 months)
Primary	measurement of biological parameters : Change in sperm motility count in men	Change in sperm motility count per ejaculate in men	T1 (=Day0 + 12 months)
Secondary	measurement of biological parameters : Antral follicle count in women	change in antral follicle count in women	T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
Secondary	measurement of biological parameters : levels of spermatozoids with sperm chromatin abnormalities	change of rate of spermatozoids with sperm chromatin abnormalities	T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
Secondary	measurement of biological parameters : Change in sperm count	Change in sperm count (spermogram) during time	T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
Secondary	measurement of biological parameters : Change in sperm motility count	Change in sperm motility count (spermogram)	T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.