Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

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

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Barusiban (FE 200440)
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A. FE 200440<br>Barusiban (FE 200440) Solution for Injection for Subcutaneous use | Drug: Barusiban (FE 200440)<br> <br> |
| Placebo Comparator: B. Placebo<br>Placebo Solution for Injection for Subcutaneous use | Drug: Placebo Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing implantation rate |  | 10-11 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |