Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05429138
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2022-05-12
Brief Title:
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MELpreserv
Brief 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None