Infertility Clinical Trial
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.
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.
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 site's 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
p=0.05. The secondary end-points will also be compared between the 2 arms using either the
Student's t test or anova test.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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