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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00894946




Registration number
NCT00894946
Ethics application status
Date submitted
6/05/2009
Date registered
7/05/2009
Date last updated
7/05/2009

Titles & IDs
Public title
The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study
Scientific title
The in Vitro Fertilisation - Lipiodol Uterine Bathing Effect Study
Secondary ID [1] 0 0
IVF-LUBE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 0 0
In Vitro Fertilization Implantation Failure 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Lipiodol + IVF
Treatment: Surgery - IVF

Experimental: Recurrent IVF implantation failure -

Experimental: Endometriosis -


Treatment: Surgery: Lipiodol + IVF
IVF preceded by lipiodol

Treatment: Surgery: IVF
IVF alone
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Live birth
Timepoint [1] 0 0
12 months post-randomization
Secondary outcome [1] 0 0
Clinical pregnancy
Timepoint [1] 0 0
3 months post-randomization
Secondary outcome [2] 0 0
Adverse events
Timepoint [2] 0 0
3 & 12 months post-randomization

Eligibility
Key inclusion criteria
* 12 or more months infertility
* Age 18 to 39
* Endometriosis or recurrent IVF implantation failure
* Patent fallopian tubes
Minimum age
18 Years
Maximum age
39 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Iodine allergy
* Blocked fallopian tube or tubes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2014
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00894946
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil Johnson, MD
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Neil Johnson, MD
Address 0 0
Country 0 0
Phone 0 0
+64 274360172
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00894946