EndometriosisPhase 3NCT00894946
The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study
A Phase 3 study testing Lipiodol + IVF and IVF in people with Endometriosis and In Vitro Fertilization Implantation Failure, run by University of Auckland, New Zealand at 1 site in New Zealand.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Endometriosis, In Vitro Fertilization Implantation Failure
- What is being tested?
- Lipiodol + IVF and IVF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteNew Zealand
- Study dates
- May 2009to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 12 or more months infertility
- Age 18 to 39
- Endometriosis or recurrent IVF implantation failure
- Patent fallopian tubes
Who cannot join
- Iodine allergy
- Blocked fallopian tube or tubes
Trial locations and contacts
1 site in 1 country.
Shelley Reilly, MRANZCOG contact
New Zealand1 site, 1 recruiting
- Recruiting
University of Auckland
Auckland
Neil Johnson, MD, +64 274 360172, n.johnson@auckland.ac.nz
Neil P Johnson, MD
About this study
Official title: 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.
- Being tested
- Lipiodol + IVF, IVF
- Keywords
- recurrent IVF implantation failure
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipiodol + IVFProcedure or surgery
IVF preceded by lipiodol
IVFProcedure or surgery
IVF alone
| Study group | Role | What they receive |
|---|---|---|
| Recurrent IVF implantation failure | Experimental | Not described Receives: Procedure: Lipiodol + IVF; Procedure: IVF |
| Endometriosis | Experimental | Not described Receives: Procedure: Lipiodol + IVF; Procedure: IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Measured: 12 months post-randomization
Secondary outcomes (2)
Clinical pregnancy
Measured: 3 months post-randomization
Adverse events
Measured: 3 & 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Investigators
- Neil Johnson, MD, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894946
- Sponsor's protocol ID
- IVF-LUBE
- Status last verified
- May 2009
- First submitted
- 6 May 2009
- Last updated
- 7 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The in Vitro Fertilisation - Lipiodol Uterine Bathing Effect Study
- ClinicalTrials.gov ID
- NCT00894946
- Acronym / sponsor ID
- IVF-LUBE
- Keywords
- recurrent IVF implantation failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 7 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent IVF implantation failure | Experimental | Procedure: Lipiodol + IVF, Procedure: IVF |
| Endometriosis | Experimental | Procedure: Lipiodol + IVF, Procedure: IVF |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 12 or more months infertility
- Age 18 to 39
- Endometriosis or recurrent IVF implantation failure
- Patent fallopian tubes
Key exclusion criteria (2 listed)
- Iodine allergy
- Blocked fallopian tube or tubes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipiodol + IVFIVF preceded by lipiodol | Procedure or surgery | Endometriosis, Recurrent IVF implantation failure |
| IVFIVF alone | Procedure or surgery | Endometriosis, Recurrent IVF implantation failure |
Primary outcome
Live birth
Time frame: 12 months post-randomization
2 secondary outcomes
Clinical pregnancy
Time frame: 3 months post-randomization
Adverse events
Time frame: 3 & 12 months post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley Reilly, MRANZCOG contact
Neil Johnson, MD principal investigator
University of Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lipiodol + IVF and IVF in people with Endometriosis and In Vitro Fertilization Implantation Failure, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neil Johnson, MD (+64 274360172, n.johnson@auckland.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth (time frame: 12 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2009; AzTrials last refreshed its copy on 1 Nov 2026.