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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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