Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

A Randomised, Placebo-controlled, Double-blind, Parallel Groups, Multinational, Multicentre Trial Assessing the Effect of Barusiban Administered Subcutaneously on the Day of Transfer on Implantation and Pregnancy Rates in IVF/ICSI Patients

This trial investigates the effects of FE 200440 compared to placebo on implantation rate in women undergoing IVF/ICSI treatment

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