Safety and Efficacy of a Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing IVF (CONSORT)
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|ClinicalTrials.gov Identifier: NCT00249834|
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : November 7, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Other: CONSORT calculator||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||September 2004|
|Primary Completion Date :||January 2006|
|Study Completion Date :||March 2006|
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249834