NCT01723982

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2012

Geographic Reach
6 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

1.9 years

First QC Date

October 5, 2012

Last Update Submit

June 15, 2015

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing implantation rate

    10-11 weeks after embryo transfer

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

A. FE 200440

EXPERIMENTAL

Barusiban (FE 200440) Solution for Injection for Subcutaneous use

Drug: Barusiban (FE 200440)

B. Placebo

PLACEBO COMPARATOR

Placebo Solution for Injection for Subcutaneous use

Drug: Placebo Comparator

Interventions

Barusiban (FE 200440)DRUG
A. FE 200440
Placebo ComparatorDRUG
B. Placebo

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Westmead Fertility Centre

Westmead, New South Wales, Australia

Location

Monash IVF

Clayton, Victoria, Australia

Location

Melbourne IVF

Melbourne, Victoria, Australia

Location

UZ Brussel

Brussels, Belgium

Location

AZ Jan Palfijn Gent AV

Ghent, Belgium

Location

Clinique OVO

Montreal, Quebec, Canada

Location

ICF CUBE

Prague, Czechia

Location

nOvum

Warsaw, Poland

Location

IVI Alicante

Alicante, Spain

Location

Dexeus

Barcelona, Spain

Location

IVI Madrid

Madrid, Spain

Location

IVI Sevilla

Seville, Spain

Location

IVI Valencia

Valencia, Spain

Location

IVI Zaragoza

Zaragoza, Spain

Location

MeSH Terms

Conditions

Infertility

Interventions

barusiban

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2012

First Posted

November 8, 2012

Study Start

November 1, 2012

Primary Completion

October 1, 2014

Study Completion

May 1, 2015

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

PL(1)CA(1)ES(6)AU(3)BE(2)CZ(1)