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

Ferring

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Drug: FE 999049; Drug: Gonal - F

Study type: Interventional

Funder types: Industry

Identifiers

NCT01426386

2011-000633-36 (EudraCT Number)

000009

Details and patient eligibility

About

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

Enrollment: 265 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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265 participants in 6 patient groups

5.2 µg

Experimental group

Treatment:

Drug: FE 999049

6.9 µg

Experimental group

Treatment:

Drug: FE 999049

8.6 µg

Experimental group

Treatment:

Drug: FE 999049

10.3 µg

Experimental group

Treatment:

Drug: FE 999049

12.1 µg

Experimental group

Treatment:

Drug: FE 999049

11 µg FbM (150 IU)

Active Comparator group

Treatment:

Drug: Gonal - F