To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen
|Infertility Ovulation Induction||Drug: Follitropin alfa liquid formulation Drug: Follitropin beta liquid formulation||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Study on the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Formulation Applied by a Pen Versus Follitropin Beta Liquid Formulation Applied by Pen|
- Convenience and Safety [ Time Frame: 1 year ]
Convenience parameters included nurse/subjects preference; time to train subject; operative tolerance and wastage of product which were assessed during the post-treatment period.
Safety parameters included local reactions (pain, bruising, redness, itching, swelling)and adverse drug events which were assessed during the pre-treatment, treatment and post-treatment period.
- Efficacy [ Time Frame: 1 year ]Collection of routine data from the RecDate registry such as: stimulation duration; FSH starting dose; FSH dosage on last treatment day; total amount of gonadotrophin needed; number of follicles on the day of the last ultra-scan; number of oocytes retrieved; number of fertilized oocytes; number of embryos transferred; wastage of product; number of cartridges of Gonal-f (300 IU, 450 IU, and 900 IU) and Puregon (300 IU and 600 IU) opened; clinical pregnancy by Ultra-scan (if already available at time point of final report writing).
|Study Start Date:||November 2003|
|Study Completion Date:||September 2004|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
Drug: Follitropin alfa liquid formulation
Follitropin alfa (Gonal-f) liquid pen (300, 450 and 900 IU) was applied by subcutaneous (sc) administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center
Other Name: Gonal-f
|Active Comparator: Puregon||
Drug: Follitropin beta liquid formulation
Follitropin beta (Puregon) liquid cartridge (300 and 600 IU) used with the Pen was applied by sc administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center
Other Name: Puregon
Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as in-vitro fertilisation (IVF) and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. Ovarian stimulation in IVF/intracytoplasmic sperm injection (ICSI) currently includes suppression of endogenous luteinizing hormone (LH) secretion by administration of a gonadotrophin releasing hormone (GnRH) agonist, followed by stimulation of multiple follicular development by exogenous FSH administration. When adequate follicular development is achieved, a single dose of u-hCG (urinary-hCG) is administered to mimic the endogenous LH surge and induce final oocyte maturation. Recombinant-human FSH (r-hFSH) has been shown to be superior to u-hFSH in terms of requiring fewer ampules and more efficacious in terms of number of oocytes recovered and in terms of pregnancy rates.
Recently, a new formulation of follitropin alfa has been developed due to a general trend in the field of therapeutic recombinant proteins to move from presentations based on biological activity to presentations based on physico-chemical characteristics. Until now follitropin alfa has been produced as a powder for injection (either as monodose or multidose preparations) in glass ampoules or in glass vials and administered using plastic or glass syringe. Serono developed a multidose solution for injection in a prefilled disposable injection pen. This study involved comparing the administration of follitropin alfa liquid formulation applied by pen with that of follitropin beta liquid formulation also applied by pen.
OBJECTIVES The objectives of this study were to evaluate the convenience, safety and efficacy of Follitropin alfa (Gonal-f) liquid pen compared with Follitropin beta (Puregon) liquid pen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081639
|Principal Investigator:||Christoph Keck, PD, Dr. med.||Universitätsfrauenklinik Freiburg|