Status:
COMPLETED
A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
20-39 years
Phase:
PHASE2
Brief Summary
This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT02309671
Start Date
December 1 2014
End Date
September 1 2016
Last Update
December 14 2020
Active Locations (1)
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1
Investigational site (there may be other sites in this country)
Tokyo, Japan