The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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 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:

MedlinePlus related topics: Endometriosis

Drug Information available for: Ethiodized oil

U.S. FDA Resources

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

Primary Outcome Measures:

Live birth [ Time Frame: 12 months post-randomization ]

Secondary Outcome Measures:

Clinical pregnancy [ Time Frame: 3 months post-randomization ]
Adverse events [ Time Frame: 3 & 12 months post-randomization ]


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 (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

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


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

Keywords provided by University of Auckland, New Zealand:


recurrent IVF implantation failure

Additional relevant MeSH terms:


Endometriosis Genital Diseases, Female Ethiodized Oil Antineoplastic Agents

ClinicalTrials.gov processed this record on July 21, 2017

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