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

Ferring

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Drug: Follitropin Delta (FE 999049); Drug: Follitropin Alfa (GONAL-F)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01956123

2013-001616-30 (EudraCT Number)

000071

U1111-1147-6922 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 513 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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513 participants in 4 patient groups

A

Experimental group

Description:

Follitropin Delta (FE 999049) (COS cycle 2)

Treatment:

Drug: Follitropin Delta (FE 999049)

B

Active Comparator group

Description:

Follitropin Alfa (GONAL-F) (COS cycle 2)

Treatment:

Drug: Follitropin Alfa (GONAL-F)

C

Experimental group

Description:

Follitropin Delta (FE 999049) (COS cycle 3)

Treatment:

Drug: Follitropin Delta (FE 999049)

D

Active Comparator group

Description:

Follitropin Alfa (GONAL-F) (COS cycle 3)

Treatment:

Drug: Follitropin Alfa (GONAL-F)