Safety and Efficacy of a Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing IVF (CONSORT in ART)
CONSORT = Clinical validation of the ART treatment guidelines, which determine the optimal dose of r hFSH based on subject baseline characteristics/predictors of ovarian response.
Phase IIIb/IV, open-label, multi-centre, multi-regional study. Subject will first be treated with a GnRH agonist according to centre's standard practice (no depot formulation will be allowed). Down-regulation is to be confirmed by E2 levels and/or US scan depending on centre's standard practice. Subject will then start r-hFSH treatment (Gonal-f® Prefilled Pen) at a pre-defined, fixed dose according to the provided ART treatment guidelines. Dose adjustment will be allowed strictly in case of risk of OHSS. Once follicular development is adequate (ie. at least 1 follicle ≥ 18mm and 2 follicles ≥ 16mm), a single injection of 250 mcg of r-hCG (Ovid[t]rel [le]®) will be administered.
Ovum Pick Up (OPU), in vitro fertilisation (IVF) and embryo transfer (ET) will be performed as per centre's standard practice.
A post-treatment safety visit will be performed for all subjects on days 15-20 post-hCG.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IIIB/IV, Open Label Study to Assess the Efficacy and Safety of a Pre-defined, Fixed Dose of Gonal-f® (Filled-by-Mass in a Prefilled Pen) Based on Subject Baseline Characteristics, for Ovarian Stimulation in Subjects Undergoing in Vitro Fertilization (IVF)|
- Number of oocytes retrieved,total dose of r-hFSH used,number of stimulation days,cycle cancellation rate,number of subjects needing dose adjustment,mean daily r-hFSH dose,implantation rate,total,clinical and multiple pregnancy rates. [ Time Frame: During ovum pick-up procedure ] [ Designated as safety issue: No ]
- Total dose of r-hFSH used,number of stimulation days,cycle cancellation rate,number of subjects needing dose adjustment,mean daily r-hFSH dose,implantation rate,total,clinical and multiple pregnancy rates.. [ Time Frame: see above mentioned timeframes for each measure ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||March 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Other: CONSORT calculator
The subject's Age, Body Mass Index (kg/m2), Number of follicles < 11 mm on a baseline ultrasound scan, Serum FSH level in the early follicular phase of a menstrual cycle were entered in an algorithm (CONSORT calculator), which then calculated the optimal fixed starting dose of r-hFSH for each subject according to her individual characteristics.