Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals

Criteria

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