Oxytocin Antagonist in Patients With Repeated Failure of Implantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by AZ Jan Palfijn Gent.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier:
NCT01673399
First received: August 23, 2012
Last updated: August 27, 2012
Last verified: August 2012
  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
Repeated Implantation Failure
Drug: Atosiban
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 AZ Jan Palfijn Gent:

Primary Outcome Measures:
  • implantation rate [ Time Frame: 16 days from eggretrieval ] [ Designated as safety issue: No ]
    the number of patients that show a positive blood pregnancy test


Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The number of patients with an ongoing first trimester pregnancy


Estimated Enrollment: 290
Study Start Date: February 2012
Estimated Primary Completion Date: February 2014 (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

Ages Eligible for Study:   18 Years to 38 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 2248850    ivf.centrum@janpalfijngent.be   
Principal Investigator: Wim Decleer, gynecologist         
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
  More Information

No publications provided

Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT01673399     History of Changes
Other Study ID Numbers: 2012-000278-49
Study First Received: August 23, 2012
Last Updated: August 27, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by AZ Jan Palfijn Gent:
repeated implantation failure
atosiban
pregnancy

Additional relevant MeSH terms:
Atosiban
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on October 29, 2014