Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01783301
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2013-01-17
Brief Title:
Anti-Mullerian Hormone AMH Versus Antral Follicle Count AFC Guided rFSH Dosing Study
Sponsor:
Vietnam National University
Organization:
Vietnam National University
Study Overview
Official Title:
A Phase IV Open-label 2 Arm Trial to Compare the Efficacy and Safety of a Pre-defined Dose of GONAL-f Based on Antral Follicle Count Follicles 2mm - 11mm or AMH for Ovarian Stimulation in Subjects Undergoing Assisted Reproductive Technology ART Treatment
Status:
COMPLETED
Status Verified Date:
2013-01
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:
None
Brief Summary:
The overall objectives of this trial are to
To explore the efficacy and safety of using either antral follicle count AFC or anti-Mullerian hormone AMH to guide the starting dose of GONAL-f in ovarian stimulation for Assisted Reproductive Technology ART
To assess the differences in both ovarian response and clinical pregnancy rate between subjects with different AFC and AMH levels undergoing ART
To explore the efficacy and safety of using either antral follicle count AFC or anti-Mullerian hormone AMH to guide the starting dose of GONAL-f in ovarian stimulation for Assisted Reproductive Technology ART
To assess the differences in both ovarian response and clinical pregnancy rate between subjects with different AFC and AMH levels undergoing ART
Detailed Description:
Trial design
This trial is a prospective Phase IV 2 arm trial exploring the efficacy and safety of using either AFC or AMH to guide the starting GONAL-f dose for the stimulation treatment of subjects undergoing ART
Throughout the trial period and before the start of a routine ART cycle investigators will propose the trial to their potential subjects All subjects who agree to participate in the trial must sign a consent form irrespective of whether or not they ultimately agree to have their dose determined by the study protocol Eligible subjects will be randomised in blocks of 4 at each site via a computer generated random number list to either the AFC guided arm control or the AMH guided arm treatment The starting doses of GONAL-f for each arm will be based on the study algorithms using AFC or AMH guidance
The investigator will then enter initiate ovarian stimulation with an individualised GONAL-f dose for that specific subject This will be maintained for the first 5 days of stimulation after which the dose can be modified based on investigator decision and in accordance with the sites routine clinical practice
Trial Population
Female partners of infertile couples requiring Assisted Reproductive Technology ART treatment
Data Analysis and Statistics
The primary end-point proportion of patients with desired number of retrieved oocytes 8-12 will be compared between the 2 arms using the chi -square test The null hypothesis will be that there is no difference between the 2 arms in primary end-point with the p level set at p005 The secondary end-points will also be compared between the 2 arms using either the Students t test or anova test
This trial is a prospective Phase IV 2 arm trial exploring the efficacy and safety of using either AFC or AMH to guide the starting GONAL-f dose for the stimulation treatment of subjects undergoing ART
Throughout the trial period and before the start of a routine ART cycle investigators will propose the trial to their potential subjects All subjects who agree to participate in the trial must sign a consent form irrespective of whether or not they ultimately agree to have their dose determined by the study protocol Eligible subjects will be randomised in blocks of 4 at each site via a computer generated random number list to either the AFC guided arm control or the AMH guided arm treatment The starting doses of GONAL-f for each arm will be based on the study algorithms using AFC or AMH guidance
The investigator will then enter initiate ovarian stimulation with an individualised GONAL-f dose for that specific subject This will be maintained for the first 5 days of stimulation after which the dose can be modified based on investigator decision and in accordance with the sites routine clinical practice
Trial Population
Female partners of infertile couples requiring Assisted Reproductive Technology ART treatment
Data Analysis and Statistics
The primary end-point proportion of patients with desired number of retrieved oocytes 8-12 will be compared between the 2 arms using the chi -square test The null hypothesis will be that there is no difference between the 2 arms in primary end-point with the p level set at p005 The secondary end-points will also be compared between the 2 arms using either the Students t test or anova test
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