Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

Infertility Clinical Trial

— BASIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723982
• Other study ID #: 000048
• Secondary ID: 2012-001622-10
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2012
• Last updated: June 15, 2015
• Start date: November 2012
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Ethics CommitteeCanada: Health CanadaCanada: Ethics Review CommitteeCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Central Register of Clinical TrialsPoland: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: May 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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 ßhCG 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Barusiban (FE 200440)

• Placebo Comparator

Locations

Country	Name	City	State
Australia	Monash IVF	Clayton	Victoria
Australia	Melbourne IVF	Melbourne	Victoria
Australia	Westmead Fertility Centre	Westmead	New South Wales
Belgium	UZ Brussel	Brussels
Belgium	AZ Jan Palfijn Gent AV	Gent
Canada	Clinique OVO	Montréal	Quebec
Czech Republic	ICF CUBE	Prague
Poland	nOvum	Warsaw
Spain	IVI Alicante	Alicante
Spain	Dexeus	Barcelona
Spain	IVI Madrid	Madrid
Spain	IVI Sevilla	Sevilla
Spain	IVI Valencia	Valencia
Spain	IVI Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Czech Republic,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing implantation rate		10-11 weeks after embryo transfer	No
Secondary	Ongoing pregnancy rate		10-11 weeks after transfer	No
Secondary	Implantation rate		5-6 weeks after transfer	No
Secondary	Clinical pregnancy rate		5-6 weeks after transfer	No
Secondary	Positive Beta Human Chorionic Gonadotrophin (ßhCG) rate		13-15 days after transfer	No
Secondary	Serum barusiban concentration at the expected tmax		30 min after 2nd IMP administration	No
Secondary	Frequency and intensity of adverse events		Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer	No
Secondary	Frequency and intensity of injection site reactions		Immediately and 30 min after each administration of IMP	No