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Completed

NCT Number: NCT01723982

Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Westmead Fertility Centre, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Barusiban (FE 200440)

Drug

placebo comparator

Drug

Primary outcomes

  1. Ongoing implantation rate

    Time frame: 10-11 weeks after embryo transfer

Secondary outcomes

  1. Ongoing pregnancy rate

    Time frame: 10-11 weeks after transfer

  2. Implantation rate

    Time frame: 5-6 weeks after transfer

  3. Clinical pregnancy rate

    Time frame: 5-6 weeks after transfer

  4. Positive Beta Human Chorionic Gonadotrophin (βhCG) rate

    Time frame: 13-15 days after transfer

  5. Serum barusiban concentration at the expected tmax

    Time frame: 30 min after 2nd IMP administration

  6. Frequency and intensity of adverse events

    Time frame: Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer

  7. Frequency and intensity of injection site reactions

    Time frame: Immediately and 30 min after each administration of IMP

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: BASIC

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Nov 8, 2012
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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