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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00894946