Status:
COMPLETED
A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
18-37 years
Phase:
PHASE2
Brief Summary
This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) 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 (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
- 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 :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT01426386
Start Date
September 1 2011
End Date
March 1 2013
Last Update
November 17 2020
Active Locations (8)
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1
UZ Brussel
Brussels, Belgium
2
UZ Gent
Ghent, Belgium
3
ICF CUBE
Prague, Czechia
4
Rigshospitalet
Copenhagen, Denmark