A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment

Ferring

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Drug: FE 999049; Drug: follitropin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT02309671

000124

Details and patient eligibility

About

This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.

Enrollment: 159 patients

Sex: Female

Ages: 20 to 39 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 and/or ICSI treatment
• Women aged 20-39 years
• Women with body mass index (BMI) of 17.5-32.0 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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159 participants in 4 patient groups

FE 999049 6 µg

Experimental group

Treatment:

Drug: FE 999049

FE 999049 9 µg

Experimental group

Treatment:

Drug: FE 999049

FE 999049 12 µg

Experimental group

Treatment:

Drug: FE 999049

FOLLISTIM 150 IU

Active Comparator group

Description:

follitropin beta

Treatment:

Drug: follitropin beta