Trial record 20 of 93 for:    Open Studies | "Fertilization in Vitro"

The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Auckland, New Zealand.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT00894946
First received: May 6, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Endometriosis
In Vitro Fertilization Implantation Failure
Procedure: Lipiodol + IVF
Procedure: IVF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The in Vitro Fertilisation - Lipiodol Uterine Bathing Effect Study

Resource links provided by NLM:


Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:
  • Live birth [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical pregnancy [ Time Frame: 3 months post-randomization ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 3 & 12 months post-randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: May 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders 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
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: 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

No publications provided

Responsible Party: Associate Professor Neil Johnson, University of Auckland
ClinicalTrials.gov Identifier: NCT00894946     History of Changes
Other Study ID Numbers: IVF-LUBE
Study First Received: May 6, 2009
Last Updated: May 6, 2009
Health Authority: New Zealand: University of Auckland Trial Steering Committee

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Ethiodized Oil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014