The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

• Sponsor: University of Auckland, New Zealand (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00894946
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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 1, 2009
• Anticipated Primary Completion Date: May 1, 2014
• Anticipated Study Completion Date: May 1, 2014

Arms and Interventions

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

Primary Outcome Measures

1. Live birth [12 months post-randomization]

Secondary Outcome Measures

1. Clinical pregnancy [3 months post-randomization]

2. Adverse events [3 & 12 months post-randomization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Auckland	Auckland		New Zealand

Sponsors and Collaborators

• University of Auckland, New Zealand

Investigators

• Principal Investigator: Neil Johnson, MD, University of Auckland, New Zealand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00894946
• Other Study ID Numbers: IVF-LUBE
• First Posted: May 7, 2009
• Last Update Posted: May 7, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: recurrent IVF implantation failure
• Additional relevant MeSH terms: Endometriosis; Ethiodized Oil

Study Results

No Results Posted as of May 7, 2009