A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme

This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.

Inclusion Criteria:

• Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
• Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
• Women aged 18-37 years
• Women with body mass index (BMI) of 18.5-32.0 kg/m2

Exclusion Criteria:

• Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
• Women with history of recurrent miscarriage
• Women with contraindications to controlled ovarian stimulation with gonadotropins
• Women with three or more controlled ovarian stimulation cycles