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Trial registered on ANZCTR


Registration number
ACTRN12614000626662
Ethics application status
Approved
Date submitted
10/06/2014
Date registered
13/06/2014
Date last updated
29/07/2019
Date data sharing statement initially provided
29/07/2019
Date results information initially provided
29/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pipelle for pregnancy in women undergoing single, autologous, embryo transfer
Scientific title
A randomised controlled trial assessing the effect of endometrial pipelle biopsy vs. no intervention on live birth rate in women undergoing autologous embryo transfer.
Secondary ID [1] 284672 0
Nil
Universal Trial Number (UTN)
U111111556458
Trial acronym
PIP-IVF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subfertility 292011 0
Condition category
Condition code
Reproductive Health and Childbirth 292355 292355 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women randomised to the intervention arm will undergo a single endometrial pipelle biopsy performed between day 3 of the natural menstrual cycle preceding their embryo transfer cycle and day 3 of the menstrual cycle in which embryo transfer is planned
Intervention code [1] 289455 0
Treatment: Other
Comparator / control treatment
Women randomised to the control group will not undergo any treatment in addition to standard care. Standard care may involve aspects common to an IVF or embryo transfer cycle, such as hormonal down-regulation and ovarian hyper-stimulation, oocyte pickup, embryo transfer, luteal phase support etc.
Control group
Active

Outcomes
Primary outcome [1] 292210 0
Live birth - delivery of a live infant at least 20 weeks gestation
Timepoint [1] 292210 0
Approximately 9 months after embryo transfer
Secondary outcome [1] 308410 0
Clinical pregnancy - on ultrasound, the presence of at least one gestational sac
Timepoint [1] 308410 0
6 weeks after embryo transfer
Secondary outcome [2] 308411 0
Ongoing pregnancy - on ultrasound, the presence of at least one gestational sac and heartbeat
Timepoint [2] 308411 0
12 weeks after embryo transfer
Secondary outcome [3] 308412 0
Multiple pregnancy - on ultrasound, the presence of more than one heartbeat
Timepoint [3] 308412 0
6 weeks after embryo transfer
Secondary outcome [4] 308413 0
Adverse events - including miscarriage, still birth, termination, ectopic pregnancy, pain or bleeding following the procedure, infection etc. and characteristics and complications related to the pregnancy, delivery, neonates and placenta (e.g. gestational diabetes, placenta accreta)
Timepoint [4] 308413 0
Bleeding and pain: on the day of the procedure or the following day
Infection: for 1 month following the procedure
Ectopic pregnancy, termination and miscarriage: up to 20 weeks following pregnancy
Still birth and characteristics and complications: during pregnancy and up to approximately 50 weeks following the procedure (to the outcome of the pregnancy)
Secondary outcome [5] 350601 0
Biochemical pregnancy - either a home urinary pregnancy test or Bhcg blood test
Timepoint [5] 350601 0
Normally approximately two weeks following embryo transfer

Eligibility
Key inclusion criteria
Women planning to undergo autologous embryo transfer with any indication of subfertility
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have had any disruptive instrumentation within the uterine cavity (e.g. hysteroscopy, hysterosalpingogram, laparoscopy, surgically managed miscarriage or endometrial biopsy) within three months prior to day one of the planned embryo transfer cycle, or planning to undergo a procedure involving disruptive instrumentation at any stage during the study. Embryo transfer and intrauterine insemination procedures are not considered to cause disruptive instrumentation
2. Entered previously into this study or participation in another trial in the last 30 days
3. Any contraindication to endometrial biopsy, being pregnant and/or carrying a pregnancy to term
4. Not planning an embryo transfer (e.g. fertility preservation or planned freeze-all cycles)

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)
To ensure allocation concealment, randomisation of eligible individuals will be performed by an online randomisation system built into the data collection software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated block randomisation schedule, stratified for each fertility centre, will be created and protected by the database manager.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
VIC
Recruitment hospital [1] 4710 0
The Royal Women's Hospital - Parkville
Recruitment outside Australia
Country [1] 6072 0
New Zealand
State/province [1] 6072 0
Country [2] 7355 0
Belgium
State/province [2] 7355 0
Leuven
Country [3] 7356 0
Sweden
State/province [3] 7356 0
Gothenburg
Country [4] 10714 0
United Kingdom
State/province [4] 10714 0

Funding & Sponsors
Funding source category [1] 289363 0
Hospital
Name [1] 289363 0
Auckland District Health Board
Address [1] 289363 0
Bldg 14, Greenlane Clinical Centre Level 7/214 Green Ln W, Greenlane 1051
Country [1] 289363 0
New Zealand
Funding source category [2] 300392 0
Charities/Societies/Foundations
Name [2] 300392 0
Nurture Foundation for Reproductive Research
Address [2] 300392 0
Level 12, Auckland City Hospital
Grafton, Auckland
New Zealand
Country [2] 300392 0
New Zealand
Funding source category [3] 300393 0
Charities/Societies/Foundations
Name [3] 300393 0
Maurice & Phyllis Paykel Trust
Address [3] 300393 0
89 Grafton Road
Auckland 1148
Country [3] 300393 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District Health Board
Address
Bldg 14, Greenlane Clinical Centre Level 7/214 Green Ln W, Greenlane 1051
Country
New Zealand
Secondary sponsor category [1] 288048 0
None
Name [1] 288048 0
Address [1] 288048 0
Country [1] 288048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291058 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 291058 0
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 291058 0
New Zealand
Date submitted for ethics approval [1] 291058 0
29/04/2014
Approval date [1] 291058 0
06/06/2014
Ethics approval number [1] 291058 0
14/NTA/62

Summary
Brief summary
A number of studies have been published which appear to show that performing an endometrial biopsy results in an increase in pregnancy and live birth rates.

Most of the studies have been conducted in a focussed subgroup of women, such as those with recurrent implantation failure, and there is little data available on the utility of endometrial biopsy prior to frozen-thaw embryo transfer.

To address these limitations, PIP-IVF is a pragmatic randomised trial recruiting all women undergoing autologous embryo transfer, and has been powered to allow detection of subgroup effects such women undergoing their first IVF cycle and women undergoing frozen-thaw transfers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48722 0
Prof Cynthia Farquhar
Address 48722 0
Department of Obstetrics and Gynaecology and National Women's Health,
University of Auckland,
Level 12, ACH Support Building,
Auckland City Hospital,
Park Road, Grafton
Private Bag 92019
Auckland 1020
Country 48722 0
New Zealand
Phone 48722 0
+64 9 3737599 EXT 89493
Fax 48722 0
Email 48722 0
c.farquhar@auckland.ac.nz
Contact person for public queries
Name 48723 0
Miss Sarah Lensen
Address 48723 0
Department of Obstetrics and Gynaecology and National Women's Health,
University of Auckland,
Level 12, ACH Support Building,
Auckland City Hospital,
Park Road, Grafton
Private Bag 92019
Auckland 1020
Country 48723 0
New Zealand
Phone 48723 0
+64 9 9239487
Fax 48723 0
Email 48723 0
s.lensen@auckland.ac.nz
Contact person for scientific queries
Name 48724 0
Prof Cynthia Farquhar
Address 48724 0
Department of Obstetrics and Gynaecology and National Women's Health,
University of Auckland,
Level 12, ACH Support Building,
Auckland City Hospital,
Park Road, Grafton
Private Bag 92019
Auckland 1020
Country 48724 0
New Zealand
Phone 48724 0
+64 9 3737599 EXT 89493
Fax 48724 0
Email 48724 0
c.farquhar@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 3444 0
A Randomized Trial of Endometrial Scratching before In Vitro Fertilization
Sarah Lensen, Ph.D., Diana Osavlyuk, M.Sc., Sarah Armstrong, M.B., Ch.B., M.R.C.O.G., Caroline Stadelmann, M.D., Aurélie Hennes, M.Sc., Emma Napier, B.Sc., Jack Wilkinson, Ph.D., Lynn Sadler, M.P.H., Devashana Gupta, C.R.E.I., Annika Strandell, M.D., Ph.D., Christina Bergh, M.D., Ph.D., Kugajeevan Vigneswaran, M.R.C.O.G., et al. January 24, 2019 N Engl J Med 2019; 380:325-334 DOI: 10.1056/NEJMoa1808737
Attachments [1] 3444 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary