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

• Status: Completed
• Trial end date: 2017-01-03
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Follicle Stimulating Hormone

Criteria

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.