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The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

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ClinicalTrials.gov Identifier: NCT00894946
Recruitment Status : Unknown
Verified May 2009 by University of Auckland, New Zealand.
Recruitment status was:  Recruiting
First Posted : May 7, 2009
Last Update Posted : May 7, 2009
Sponsor:
Information provided by:
University of Auckland, New Zealand

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The hypothesis of this study is that Lipiodol uterine bathing improves the success rate of in vitro fertilization (IVF) for women with endometriosis or recurrent IVF implantation failure.

Condition or disease Intervention/treatment Phase
Endometriosis In Vitro Fertilization Implantation Failure Procedure: Lipiodol + IVF Procedure: IVF Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The in Vitro Fertilisation - Lipiodol Uterine Bathing Effect Study
Study Start Date : May 2009
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Recurrent IVF implantation failure Procedure: Lipiodol + IVF
IVF preceded by lipiodol
Procedure: IVF
IVF alone
Experimental: Endometriosis Procedure: Lipiodol + IVF
IVF preceded by lipiodol
Procedure: IVF
IVF alone


Outcome Measures
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Primary Outcome Measures :
  1. Live birth [ Time Frame: 12 months post-randomization ]

Secondary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 3 months post-randomization ]
  2. Adverse events [ Time Frame: 3 & 12 months post-randomization ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 or more months infertility
  • Age 18 to 39
  • Endometriosis or recurrent IVF implantation failure
  • Patent fallopian tubes

Exclusion Criteria:

  • Iodine allergy
  • Blocked fallopian tube or tubes
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00894946


Contacts
Contact: Neil Johnson, MD +64 274360172 n.johnson@auckland.ac.nz
Contact: Shelley Reilly, MRANZCOG sreilly@adhb.govt.nz

Locations
New Zealand
University of Auckland Recruiting
Auckland, New Zealand
Contact: Neil Johnson, MD    +64 274 360172    n.johnson@auckland.ac.nz   
Principal Investigator: Neil P Johnson, MD         
Sub-Investigator: Shelley J Reilly, MRANZCOG         
Sub-Investigator: Cindy M Farquhar, MD         
Sub-Investigator: Alistair Stewart         
Sponsors and Collaborators
University of Auckland, New Zealand
Investigators
Principal Investigator: Neil Johnson, MD University of Auckland, New Zealand
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Associate Professor Neil Johnson, University of Auckland
ClinicalTrials.gov Identifier: NCT00894946     History of Changes
Other Study ID Numbers: IVF-LUBE
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: May 7, 2009
Last Verified: May 2009

Keywords provided by University of Auckland, New Zealand:
recurrent IVF implantation failure

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Ethiodized Oil
Antineoplastic Agents