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Trial registered on ANZCTR


Registration number
ACTRN12613001046796
Ethics application status
Approved
Date submitted
13/09/2013
Date registered
19/09/2013
Date last updated
19/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Local Endometrial Trauma (LET) in Patients with Recurrent Implantation Failure
Scientific title
A comparison of Local Endometrial Trauma (LET) versus no trauma on failed implantation rates in IVF patients with recurrent implantation failure.
Secondary ID [1] 283211 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent implantation failure 290073 0
Condition category
Condition code
Reproductive Health and Childbirth 290457 290457 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Local Endometrial Trauma (LET), a randomised timed Pipelle endometrial biopsy. This would be done in the mid-luteal phase in the month immediately preceding the IVF treatment.
Intervention code [1] 287938 0
Treatment: Surgery
Comparator / control treatment
A randomised timed placebo biopsy where the patient would have the insertion of the Pipelle device into the cervix but not into the uterine cavity and no vacuum being drawn, thereby avoiding endometrial trauma whilst giving the impression of a biopsy. This would be done in the mid-luteal phase in the month immediately preceding IVF treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 290483 0
Clinical pregnancy (i.e. the prescence of fetal heart activity as seen on transvaginal ultrasound approxiamtely four weeks after embryo transfer).
Timepoint [1] 290483 0
4 weeks after embryo transfer
Secondary outcome [1] 304599 0
The effect of the LET procedure on positive serum HCG pregnancy test two weeks after embryo transfer
Timepoint [1] 304599 0
2 weeks after embryo transfer
Secondary outcome [2] 304704 0
Pregnancy outcome up to delivery. Seen by regular pregnancy monitoring such as ultrasound, blood pressure testing and urine testing.
Timepoint [2] 304704 0
40 weeks
Secondary outcome [3] 304705 0
Endometrial tissue collected during the LET will be analysed for markers of successful implantation such as activin A, activin B, follistatin and their receptors.
Timepoint [3] 304705 0
Mid luteal phase in the month immediately preceding the IVF treatment

Eligibility
Key inclusion criteria
Patients about to undergo a cycle of IVF/ICSI treatment involving fresh embryo transfer, who has a history of recurrent implantation failure in IVF/ICSI treatment.
Minimum age
21 Years
Maximum age
39 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient under 21 or over 39 years of age
Known uterine abnormality
Medical contradiction to superovulation, oocyte collection or embryo transfer
Unable to give informed consent

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 287956 0
Commercial sector/Industry
Name [1] 287956 0
IVF Australia
Address [1] 287956 0
Level 2
176 Pacific Highway
Greenwich NSW 2065.
Country [1] 287956 0
Australia
Primary sponsor type
Individual
Name
Prof William Ledger
Address
Level 1, Royal Hospital for Women
Barker Street, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 286677 0
University
Name [1] 286677 0
University of New South Wales
Address [1] 286677 0
High St, Kensington NSW 2052
Country [1] 286677 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The objective of this study is to determine wether local endometrium trauma (LET), applied once during the mid-luteal phase of the cycle preceding in vitro fertilization (IVF) treatment, can improve the chance of pregnancy for women with recurrent implantation failure.

The primary aim of this study will be the prescence of fetal heart activity seen on transvaginal ultrasound approximately four weeks after embryo trasnfer.

The secondary outcome will be the effect of the LET procedure on positive pregnancy test two weeks after embryo transfer, ongoing pregnancy, pregnancy outcome and complications up to delivery. Endometrail tissue collected during the LET will be analysed for putative markers of successful implantation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42926 0
Prof William Ledger
Address 42926 0
Level 1, Royal Hospital for Women
Barker Street (locked bag 2000)
Randwick NSW 2031
Country 42926 0
Australia
Phone 42926 0
+61293826515
Fax 42926 0
Email 42926 0
w.ledger@unsw.edu.au
Contact person for public queries
Name 42927 0
Prof William Ledger
Address 42927 0
Level 1, Royal Hospital for Women
Barker Street (locked bag 2000)
Randwick NSW 2031
Country 42927 0
Australia
Phone 42927 0
+61293826515
Fax 42927 0
Email 42927 0
w.ledger@unsw.edu.au
Contact person for scientific queries
Name 42928 0
Prof William Ledger
Address 42928 0
Level 1, Royal Hospital for Women
Barker Street (locked bag 2000)
Randwick NSW 2031
Country 42928 0
Australia
Phone 42928 0
+61293826515
Fax 42928 0
Email 42928 0
w.ledger@unsw.edu.au

No data has been provided for results reporting
Summary results
Not applicable