The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

May 6, 2009 updated by: University of Auckland, New Zealand

The in Vitro Fertilisation - Lipiodol Uterine Bathing Effect Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • University of Auckland
        • Contact:
        • Principal Investigator:
          • Neil P Johnson, MD
        • Sub-Investigator:
          • Shelley J Reilly, MRANZCOG
        • Sub-Investigator:
          • Cindy M Farquhar, MD
        • Sub-Investigator:
          • Alistair Stewart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth
Time Frame: 12 months post-randomization
12 months post-randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy
Time Frame: 3 months post-randomization
3 months post-randomization
Adverse events
Time Frame: 3 & 12 months post-randomization
3 & 12 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Auckland, New Zealand

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ANTICIPATED)

May 1, 2014

Study Completion (ANTICIPATED)

May 1, 2014

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 6, 2009

First Posted (ESTIMATE)

May 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2009

Last Update Submitted That Met QC Criteria

May 6, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVF-LUBE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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