An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)
This is a prospective, observational study in women using Gonal-F filled-by-mass (FbM) in ovarian hyperstimulation as part of their in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment at infertility clinics in Korea. The purpose of this study is to assess Gonal-F FbM in a practical setting encompassing all subject groups and local practices.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Prospective, Multi-center, Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to IVF/ICSI|
- Efficacy [ Time Frame: Start of treatment to confirmation of pregnancy ] [ Designated as safety issue: No ]Number of oocytes retrieved and clinical pregnancy rate per cycle
- Efficacy, Safety and Convenience [ Time Frame: Start of treatment to confirmation of pregnancy ] [ Designated as safety issue: Yes ]
Secondary efficacy parameters includes total Gonal-f dose; stimulation profile of IVF cycle; number of follicles > 14 mm on day of hCG; number of available embryos; pregnancy status (hCG test, ultrasound exam); on the day of embryo transfer (ET).
Convenience and safety parameters includes subject convenience rated by completing a questionnaire, local tolerance assessment (local reactions at the injection site, pain, satisfaction and convenience)
Biospecimen Retention: Samples Without DNA
|Study Start Date:||April 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Drug: Gonal-F (Follitropin alfa)
Follicle stimulating hormone (FSH) is a complex hetero-dimeric glycoprotein used therapeutically to stimulate follicular development in the ovary. The technical advance of recombinant technology to manufacture FSH has resulted in a biochemically pure FSH preparation with high batch-to-batch consistency. The protein content can be reliably quantified in mass units by size exclusion high performance liquid chromatography. These developments have enabled recombinant human FSH follitropin alfa (Gonal-F) to be filled and released in vials on the basis of mass with a variability of only ±2%. In one study, the FbM batches appeared to deliver a more consistent therapeutic effect than the filled-by-bioassay batches. In another randomized trial, self-administration and subjects' satisfaction were significantly higher in the pen device group than the conventional syringe group. Local reactions at injection sites and pain were significantly higher in the conventional syringe group than in the pen device group. The authors concluded that the pen device of Gonal-F is safe, convenient, and less painful, with more subject satisfaction than the conventional syringe form.
This prospective, multicentric, observational study is planned in women using Gonal-F FbM in ovarian hyperstimulation as part of their IVF/ICSI treatment at infertility clinics in Korea. Subjects fulfilling the eligibility criteria shall be enrolled in a consecutive manner over a 9-month period (approximately 1500 subjects).
- To assess the effectiveness Gonal-F FbM
- To assess the safety and subject convenience of Gonal-F FbM in a normal clinical practice over a period of 9 months