Clinical trial NCT01723982: Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-08
Enrollment: 256
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Ongoing implantation rate
timeFrame: 10-11 weeks after embryo transfer
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 10-11 weeks after transfer
measure: Implantation rate
timeFrame: 5-6 weeks after transfer
measure: Clinical pregnancy rate
timeFrame: 5-6 weeks after transfer
measure: Positive Beta Human Chorionic Gonadotrophin (βhCG) rate
timeFrame: 13-15 days after transfer
measure: Serum barusiban concentration at the expected tmax
timeFrame: 30 min after 2nd IMP administration
measure: Frequency and intensity of adverse events
timeFrame: Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer
measure: Frequency and intensity of injection site reactions
timeFrame: Immediately and 30 min after each administration of IMP
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Fertility Centre
state: New South Wales
city: Clayton
country: Australia
facility: Monash IVF
state: Victoria
city: Melbourne
country: Australia
facility: Melbourne IVF
state: Victoria
city: Brussels
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: AZ Jan Palfijn Gent AV
city: Montréal
country: Canada
facility: Clinique OVO
state: Quebec
city: Prague
country: Czech Republic
facility: ICF CUBE
city: Warsaw
country: Poland
facility: nOvum
city: Alicante
country: Spain
facility: IVI Alicante
city: Barcelona
country: Spain
facility: Dexeus
city: Madrid
country: Spain
facility: IVI Madrid
city: Sevilla
country: Spain
facility: IVI Sevilla
city: Valencia
country: Spain
facility: IVI Valencia
city: Zaragoza
country: Spain
facility: IVI Zaragoza
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: