Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2

A Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Evaluating the Immunogenicity of FE 999049 in Repeated Cycles of Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

This trial investigates the immunogenicity of FE 999049 in repeated cycles.

Inclusion Criteria:

• Informed Consent Documents signed prior to screening evaluations related to this protocol
• Participation in the pivotal efficacy trial (trial 000004/ESTHER-1)
• Anti-FSH antibody results from baseline and at least one post-dosing assessment in the previous cycle(s) available.
• Having undergone the oocyte retrieval procedure, or having had cycle cancellation prior to oocyte retrieval due to poor ovarian response or excessive ovarian response, in the previous cycle(s).
• Failure to achieve ongoing pregnancy in the previous cycle(s).

Exclusion Criteria:

• Non-compliance to protocol compliance in the previous cycle(s).
• Having undergone any stimulation with gonadotropins since the end-of-trial / end-of-cycle visit in the previous cycle
• One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to start of dosing on stimulation day 1
• Severe OHSS in a previous cycle.
• Any clinically relevant change to any of the eligibility criteria in the previous cycle(s).
• Clinically relevant medical history since the previous cycle which precludes gonadotropin stimulation or is associated with a reduced chance of pregnancy.