Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02856048
Status:
UNKNOWN
Last Update Posted:
2019-12-17
First Post:
2016-07-19
Brief Title:
Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Assessment of the Effect of a Co-treatment With GnRH Analogs on the Ovarian Reserve in Adolescents and Young Women Treated With Alkylating Agents for Cancer
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
PRESOV
Brief Summary:
The purpose of this study is to determine the efficacy of a temporary ovarian suppression obtained by administration of a gonadotropin releasing hormone agonist during alkylating agents containing chemotherapy on ovarian reserve assessed by Anti-Müllerian hormone AMH serum levels in adolescents and young women with cancer
Detailed Description:
This is a French Prospective Multicentre Open Randomised study To determine the efficacy of a temporary ovarian suppression obtained by administration of a Gonadotropin Releasing Hormone agonist GnRHa on maintaining ovarian reserve patients will be randomized half of them receiving Triptorelin extended release LP 3 mg intramuscularly every 283 days starting at the inclusion visit and at least 72 days before chemotherapy with alkylating agents until 1 month after end of chemotherapy mean duration 12 months
The primary objective of the study is to determine the effect of a temporary ovarian suppression achieved through administration of a gonadotropin releasing hormone agonist triptorelin LP 3 mg during alkylating agents containing chemotherapy on ovarian reserve assessed by AMH serum levels in adolescents and young women with cancer
Number of centres 19 Research period
Recruitment duration 2 years
The duration of participation of each patient is 3 years
The duration of the treatment period is 1 year
The duration of the follow-up period is 2 years
Total duration 5 years
Statistical analysis
1 Sample size and design One Hundred and sixty 160 patients will be included in this study in order to ensure at least 128 patients who will complete the study
This number of patients should allow us to identify with a power of 80 a difference of 5 pmolL in AMH serum levels between the two groups when accepting a risk alpha of 005
2 Analysis populations The main analysis will be an intention-to-treat ITT analysis which will be performed on all the randomized patients with a value of the main criterion of judgment AMH level at M24 A per-protocol PP analysis will also be performed as a secondary analysis excluding patients with major protocol deviation defined a priori
3 Primary criteria The value of AMH level at month 24will be compared between the two treatment groups using a test t of Student if AMH values are normally distributed and a non-parametric Wilcoxon test if not
The primary objective of the study is to determine the effect of a temporary ovarian suppression achieved through administration of a gonadotropin releasing hormone agonist triptorelin LP 3 mg during alkylating agents containing chemotherapy on ovarian reserve assessed by AMH serum levels in adolescents and young women with cancer
Number of centres 19 Research period
Recruitment duration 2 years
The duration of participation of each patient is 3 years
The duration of the treatment period is 1 year
The duration of the follow-up period is 2 years
Total duration 5 years
Statistical analysis
1 Sample size and design One Hundred and sixty 160 patients will be included in this study in order to ensure at least 128 patients who will complete the study
This number of patients should allow us to identify with a power of 80 a difference of 5 pmolL in AMH serum levels between the two groups when accepting a risk alpha of 005
2 Analysis populations The main analysis will be an intention-to-treat ITT analysis which will be performed on all the randomized patients with a value of the main criterion of judgment AMH level at M24 A per-protocol PP analysis will also be performed as a secondary analysis excluding patients with major protocol deviation defined a priori
3 Primary criteria The value of AMH level at month 24will be compared between the two treatment groups using a test t of Student if AMH values are normally distributed and a non-parametric Wilcoxon test if not
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-001121-17 | EUDRACT_NUMBER | None | None |