Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: Barusiban (FE 200440); Drug: Placebo Comparator

• Registration Number: NCT01723982
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-05
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-08
• Primary Completion: 2014-10
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A. FE 200440	Barusiban (FE 200440)	Barusiban (FE 200440) Solution for Injection for Subcutaneous use
B. Placebo	Placebo Comparator	Placebo Solution for Injection for Subcutaneous use

Primary Outcome Measures

Name	Time	Method
Ongoing implantation rate	10-11 weeks after embryo transfer

Secondary Outcome Measures

Name	Time	Method
Frequency and intensity of injection site reactions	Immediately and 30 min after each administration of IMP
Ongoing pregnancy rate	10-11 weeks after transfer
Implantation rate	5-6 weeks after transfer
Clinical pregnancy rate	5-6 weeks after transfer
Frequency and intensity of adverse events	Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo 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

Trial Locations

Locations (14)

ICF CUBE; 🇨🇿 Prague, Czech Republic

Westmead Fertility Centre; 🇦🇺 Westmead, New South Wales, Australia

Monash IVF; 🇦🇺 Clayton, Victoria, Australia

Melbourne IVF; 🇦🇺 Melbourne, Victoria, Australia

Clinique OVO; 🇨🇦 Montréal, Quebec, Canada

UZ Brussel; 🇧🇪 Brussels, Belgium

AZ Jan Palfijn Gent AV; 🇧🇪 Gent, Belgium

IVI Alicante; 🇪🇸 Alicante, Spain

Dexeus; 🇪🇸 Barcelona, Spain

IVI Madrid; 🇪🇸 Madrid, Spain

nOvum; 🇵🇱 Warsaw, Poland

IVI Sevilla; 🇪🇸 Sevilla, Spain

IVI Valencia; 🇪🇸 Valencia, Spain

IVI Zaragoza; 🇪🇸 Zaragoza, Spain