Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions (BASIC)

Ferring

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Drug: Barusiban (FE 200440); Drug: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01723982

000048

2012-001622-10 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 256 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups, including a placebo group

A. FE 200440

Experimental group

Description:

Barusiban (FE 200440) Solution for Injection for Subcutaneous use

Treatment:

Drug: Barusiban (FE 200440)

B. Placebo

Placebo Comparator group

Description:

Placebo Solution for Injection for Subcutaneous use

Treatment:

Drug: Placebo Comparator