NCT01183143

Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization

A Multicentre, Open-label, Non-comparative Phase IIIb Study to Evaluate the Acceptability of GONAL-f® Prefilled Liquid Formulation Administered by Pen in an Outpatient Setting for Ovarian Stimulation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm \[recombinant follicle stimulating hormone (r-FSH)\] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).

Conditions

• Infertility
• Ovulation Induction
• In-Vitro Fertilization

Interventions

Type	Name	Description
DRUG	GONAL-f®	GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.

Timeline

• Start date: 2004-05-11
• Primary completion: 2006-03-02
• Completion: 2006-03-02
• First posted: 2010-08-17
• Last updated: 2018-04-06
• Results posted: 2018-04-06

Locations

1 site across 1 country: Germany