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The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

Primary Purpose

Endometriosis, In Vitro Fertilization Implantation Failure

Status
Unknown status
Phase
Phase 3
Locations
New Zealand
Study Type
Interventional
Intervention
Lipiodol + IVF
IVF
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring recurrent IVF implantation failure

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of AucklandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Recurrent IVF implantation failure

Endometriosis

Arm Description

Outcomes

Primary Outcome Measures

Live birth

Secondary Outcome Measures

Clinical pregnancy
Adverse events

Full Information

First Posted
May 6, 2009
Last Updated
May 6, 2009
Sponsor
University of Auckland, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT00894946
Brief Title
The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study
Official Title
The in Vitro Fertilisation - Lipiodol Uterine Bathing Effect Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Auckland, New Zealand

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, In Vitro Fertilization Implantation Failure
Keywords
recurrent IVF implantation failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recurrent IVF implantation failure
Arm Type
Experimental
Arm Title
Endometriosis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Lipiodol + IVF
Intervention Description
IVF preceded by lipiodol
Intervention Type
Procedure
Intervention Name(s)
IVF
Intervention Description
IVF alone
Primary Outcome Measure Information:
Title
Live birth
Time Frame
12 months post-randomization
Secondary Outcome Measure Information:
Title
Clinical pregnancy
Time Frame
3 months post-randomization
Title
Adverse events
Time Frame
3 & 12 months post-randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Johnson, MD
Phone
+64 274360172
Email
n.johnson@auckland.ac.nz
First Name & Middle Initial & Last Name or Official Title & Degree
Shelley Reilly, MRANZCOG
Email
sreilly@adhb.govt.nz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Johnson, MD
Organizational Affiliation
University of Auckland, New Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Auckland
City
Auckland
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Johnson, MD
Phone
+64 274 360172
Email
n.johnson@auckland.ac.nz
First Name & Middle Initial & Last Name & Degree
Neil P Johnson, MD
First Name & Middle Initial & Last Name & Degree
Shelley J Reilly, MRANZCOG
First Name & Middle Initial & Last Name & Degree
Cindy M Farquhar, MD
First Name & Middle Initial & Last Name & Degree
Alistair Stewart

12. IPD Sharing Statement

Learn more about this trial

The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

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