The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

Endometriosis Clinical Trial

Official title:

The in Vitro Fertilisation - Lipiodol Uterine Bathing Effect Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00894946
• Other study ID #: IVF-LUBE
• Status: Recruiting
• Phase: Phase 3
• First received: May 6, 2009
• Last updated: May 6, 2009
• Start date: May 2009
• Est. completion date: May 2014

Study information

• Verified date: May 2009
• Source: University of Auckland, New Zealand
• Contact: Neil Johnson, MD
• Phone: +64 274360172
• Email: n.johnson[@]auckland.ac.nz
• Is FDA regulated: No
• Health authority: New Zealand: University of Auckland Trial Steering Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• In Vitro Fertilization Implantation Failure

Intervention

Procedure:
• Lipiodol + IVF
IVF preceded by lipiodol
• IVF
IVF alone

Locations

Country	Name	City	State
New Zealand	University of Auckland	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth		12 months post-randomization	No
Secondary	Clinical pregnancy		3 months post-randomization	No
Secondary	Adverse events		3 & 12 months post-randomization	Yes