Oxytocin Antagonist in Patients With Repeated Failure of Implantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01673399
Recruitment Status : Recruiting
First Posted : August 28, 2012
Last Update Posted : March 21, 2017
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent

Brief Summary:
In this study the investigators compare the usual way of embryo transfer (without medication) with an embryo transfer while administering oxytocine antagonist. This to improve implantation and increase the pregnancy rate.

Condition or disease Intervention/treatment Phase
Implantation Failure Drug: Atosiban Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Oxytocin Antagonist in Patients With Repeated Failure of Implantation. A Prospective Randomized Placebo-controlled Double-blind Study.
Study Start Date : February 2012
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Atosiban
Patients receive a bolus injection of 6.75mg atosiban and following an atosibaninfusion at 18mg/u during 3 hours.
Drug: Atosiban
Bolus atosiban 6.75mg + infusion atosiban 18mg/u during 3 hours. once administered starting 1 hour before embryotransfer.
Placebo Comparator: placebo
Patients receive a placebo bolus injection (NaCl 0.9%)and an infusion of NaCl 0.9% during 3 hours
Drug: placebo

Primary Outcome Measures :
  1. implantation rate [ Time Frame: 16 days from eggretrieval ]
    the number of patients that show a positive serum blood pregnancy test

Secondary Outcome Measures :
  1. pregnancy rate [ Time Frame: 12 weeks ]
    The number of patients with an ongoing first trimester pregnancy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • IVF/ ICSI patients below 38 years
  • 2e to 6e IVF-cycle

Exclusion Criteria:

  • patients with endocrinological diseases or problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01673399

Contact: Wim Decleer, gynecologist 0032 9 3259220
Contact: Paul Devroey, professor 0032 9 2248070

AZ Jan Palfijn Recruiting
Gent, Oost-vlaanderen, Belgium, 9000
Contact: Wim Decleer, gynecologist    0032 9 2243024   
Contact    0032 9 2248851   
Principal Investigator: Wim Decleer, gynecologist         
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital

Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent Identifier: NCT01673399     History of Changes
Other Study ID Numbers: 2012-000278-49
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by Dr. Decleer Wim, AZ Jan Palfijn Gent:
repeated implantation failure (RIF)

Additional relevant MeSH terms:
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Tocolytic Agents
Vasoconstrictor Agents