Infertility
Conditions
Brief summary
This trial investigates the effects of FE 200440 compared to placebo on implantation rate in women undergoing IVF/ICSI treatment
Interventions
DRUGBarusiban (FE 200440)
DRUGPlacebo Comparator
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-37 years * Women who have undergone 2-4 previous fresh in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) cycles that all resulted in a negative βhCG test, despite transfer of at least one embryo/blastocyst of good quality * Women who have in the current controlled ovarian stimulation cycle for IVF/ICSI followed the long Gonadotrophin Releasing Hormone (GnRH) agonist or GnRH antagonist protocol, received hCG for triggering of final follicular maturation and have undergone oocyte retrieval for IVF/ICSI with the purpose of fresh transfer * Retrieval of at least 6 oocytes in the current controlled ovarian stimulation cycle * Subjects should have at least one embryo of good quality available for transfer on day 3, or at least one good quality blastocyst available for transfer on day 5
Exclusion criteria
* A total of 6 or more controlled ovarian stimulation cycles for IVF/ICSI * Abnormal karyotype * Uterine pathology or hydrosalpinx * Diagnosed with acquired or congenital thrombophilia disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing implantation rate | 10-11 weeks after embryo transfer |
Secondary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy rate | 10-11 weeks after transfer |
| Implantation rate | 5-6 weeks after transfer |
| Clinical pregnancy rate | 5-6 weeks after transfer |
| Positive Beta Human Chorionic Gonadotrophin (βhCG) rate | 13-15 days after transfer |
| Serum barusiban concentration at the expected tmax | 30 min after 2nd IMP administration |
| Frequency and intensity of adverse events | Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer |
| Frequency and intensity of injection site reactions | Immediately and 30 min after each administration of IMP |
Countries
Australia, Belgium, Canada, Czechia, Poland, Spain
Outcome results
None listed