This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
265
UZ Brussel
Brussels, Belgium
UZ Gent
Ghent, Belgium
ICF CUBE
Prague, Czechia
Rigshospitalet
Copenhagen, Denmark
Number of Oocytes Retrieved
Time frame: Day of oocyte retrieval (up to Day 18 after start of stimulation)
Number and Size of Follicles During Stimulation
Follicular volume at end of stimulation
Time frame: End of stimulation (up to 16 stimulation days)
Endocrine Profile
Estradiol at end of stimulation
Time frame: End of stimulation (up to 16 stimulation days)
Total IMP Dose
Time frame: End of stimulation (up to 16 stimulation days)
Number of Fertilised Oocytes
An oocyte with 2 pronuclei was regarded as correctly fertilised
Time frame: Day 1 after insemination
Number and Quality of Blastocysts on Day 5
Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher
Time frame: Day 5 after oocyte retrieval
Clinical Pregnancy With Fetal Heart Beat Rate
Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat
Time frame: 5-6 weeks after transfer
Frequency and Intensity of Adverse Events
Time frame: From signing informed consent form until end of trial visit (up to 5 months)
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IU Dexeus
Barcelona, Spain
IVI Madrid
Madrid, Spain
IVI Sevilla
Seville, Spain
IVI Valencia
Valencia, Spain