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Oxytocin Antagonist in Patients With Repeated Failure of Implantation

This study is currently recruiting participants.
Verified March 2017 by Dr. Decleer Wim, AZ Jan Palfijn Gent
Sponsor:
ClinicalTrials.gov Identifier:
NCT01673399
First Posted: August 28, 2012
Last Update Posted: March 21, 2017
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.
Collaborator:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent
  Purpose
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 Intervention Phase
Implantation Failure Drug: Atosiban Drug: placebo Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Decleer Wim, AZ Jan Palfijn Gent:

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


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


Estimated Enrollment: 290
Study Start Date: February 2012
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with endocrinological diseases or problems
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01673399


Contacts
Contact: Wim Decleer, gynecologist 0032 9 3259220 wim.decleer@janpalfijngent.be
Contact: Paul Devroey, professor 0032 9 2248070 ivf.studie@janpalfijngent.be

Locations
Belgium
AZ Jan Palfijn Recruiting
Gent, Oost-vlaanderen, Belgium, 9000
Contact: Wim Decleer, gynecologist    0032 9 2243024    wim.decleer@janpalfijngent.be   
Contact    0032 9 2248851    ivf.studie@janpalfijngent.be   
Principal Investigator: Wim Decleer, gynecologist         
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
  More Information

Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT01673399     History of Changes
Other Study ID Numbers: 2012-000278-49
First Submitted: August 23, 2012
First Posted: August 28, 2012
Last Update Posted: March 21, 2017
Last Verified: March 2017

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

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