NCT01075854

An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)

A Prospective, Multi-center, Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to IVF/ICSI

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,539 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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). OBJECTIVES Primary objective: * To assess the effectiveness Gonal-F FbM Secondary objectives: * To assess the safety and subject convenience of Gonal-F FbM in a normal clinical practice over a period of 9 months

Conditions

• Multifollicular Stimulation

Interventions

Type	Name	Description
DRUG	Gonal-F (Follitropin alfa)	Follitropin alfa FbM solution for injection in a prefilled pen is available in three strengths: 300 IU/0.5 ml (22 µg/0.5 ml), 450 IU/0.75 ml (33 µg/0.75 ml) and 900 IU/1.5 ml (66 µg/1.5 ml). The starting dose is usually recommended to be between 150 and 300 IU. The dose is then adjusted according to the ovarian response.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2010-02-25
• Last updated: 2014-07-31

Locations

1 site across 1 country: South Korea