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

Ferring logo

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

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)

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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