Conditions: Infertility Ovulation Induction In-Vitro Fertilization
Keywords: Infertility Ovulation induction Gonal-F Follitropin alpha Controlled ovarian stimulation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 215
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: GONAL-f®
Intervention descriptions: intervention 1: 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.

Protocol document: