Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001222932
Ethics application status
Not yet submitted
Date submitted
16/11/2011
Date registered
29/11/2011
Date last updated
23/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, single blind controlled study assessing the effect of endometrial injury on live birth rate in women who are undergoing an Invitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) cycle.
Scientific title
A randomised, single blind controlled study assessing the effect of luteal phase pipelle endometrial biopsy versus sham biopsy on live birth rate in women who are undergoing an IVF/ICSI cycle.
Secondary ID [1] 273404 0
Nil
Universal Trial Number (UTN)
U1111-1125-8702
Trial acronym
The MENDIT Trial: Multicentre endometrial Injury Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 279185 0
Condition category
Condition code
Reproductive Health and Childbirth 279384 279384 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the treatment group will undergo speculum examination, the cervix will be wiped with chlorhexidine and pipelle endometrial biopsy taken between luteal days 7 to 10 (days 21 and 24 of a spontaneous 28 day cycle) preceding their IVF stimulated cycle or 4 to 7 days prior to ceasing the combined oral contraceptive pill if using a pill cross-over cycle.
This intervention will occur only once and will take approximately five minutes to complete.
Intervention code [1] 283738 0
Treatment: Other
Comparator / control treatment
Patients in the control group will undergo sham biopsy, whereby they undergo speculum examination, the cervix will be wiped with chlorhexidine and the biopsy catheter placed beside the cervix (and not into the uterus) between luteal days 7 to 10 preceding their IVF stimulated cycle or 4 to 7 days prior to ceasing the combined oral contraceptive pill if using a pill cross-over cycle.
Control group
Placebo

Outcomes
Primary outcome [1] 285972 0
Live Birth Rate
All patients who become pregnant as a result of participating in an IVF program are required to have pregnancy and neonatal outcomes recorded. This data is known as the Australian New Zealand Assisted Reproduction Database and is part of the National Perinatal Statistics Unit. Patients or their doctors are contacted routinely to collect this information. This study requires the same information to be collected.
Timepoint [1] 285972 0
At one year post randomisation
Secondary outcome [1] 294873 0
Implantation Rate.
This will be assessed by determining the number of gestational sacs on transvaginal ultrasound at 7-8 weeks of pregnancy as is part of routine clinical practice for those patients who conceive.
Timepoint [1] 294873 0
7-8 weeks of pregnancy or 12 weeks post randomisation
Secondary outcome [2] 294874 0
Biochemical Pregnancy Rate.
A quantitative serum hCG (using immunoassay) will be performed on Day 14 post oocyte retrieval.
Timepoint [2] 294874 0
Day 14 post oocyte collection
Secondary outcome [3] 294875 0
Clinical Pregnancy Rate.
This will be determined by the presence of a gestational sac on transvaginal ultrasound at 7-8 weeks of pregnancy in those women who have had a positive serum hCG on Day 14.
Timepoint [3] 294875 0
7-8 weeks of pregnancy or 12 weeks post randomisation
Secondary outcome [4] 294876 0
Endometrial Thickness.
This will be measured by transvaginal ultrasound at the time of oocyte retrieval.
Timepoint [4] 294876 0
On day of oocye retrieval

Eligibility
Key inclusion criteria
A woman requiring IVF/ICSI
Age between 18-39 years (up to 40th Birthday)
Have undergone at least 2 embryo transfers without conceiving a clinical pregnancy
Be ordered a starting dose of r-FSH of 300IU or less
Have all previous IVF cycles resulting in 3 or more oocytes
BMI 35 or less
Both ovaries present
Uterine cavity without abnormality as assessed by ultrasound, hysteroscopy or hysterosalpingography
Minimum age
18 Years
Maximum age
39 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Hysteroscopy or hysterosalpingography or endometrial biopsy within the 3 months prior to study
Paricipating in complementary medical intervention
Undergoing assisted hatching
Current smoker
Previous chemotherapy or radiotherapy

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)
Individual allocations will be kept in sequentially numbered opaque envelopes and opened on day of the intervention to determine treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated block randomisation schedule for each fertility centre will be used to allow allocation of endometrial biopsy or sham procedure. This will be known only to the clinician performing the procedure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Only the doctor performing the intervention will be aware of the allocation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4740 0
5042
Recruitment postcode(s) [2] 4741 0
5000
Recruitment outside Australia
Country [1] 3956 0
New Zealand
State/province [1] 3956 0

Funding & Sponsors
Funding source category [1] 284218 0
Charities/Societies/Foundations
Name [1] 284218 0
RANZCOG Research Foundation, Fotheringham Scholarship
Country [1] 284218 0
Australia
Primary sponsor type
Individual
Name
Phillip McChesney
Address
Fertility Associates
Level 3, Ascot Central
7 Ellerslie Racecourse Drive
Remuera, Auckland 1051
Country
New Zealand
Secondary sponsor category [1] 269174 0
Commercial sector/Industry
Name [1] 269174 0
Fertility Associates
Address [1] 269174 0
Fertility Associates
Level 3, Ascot Central
7 Ellerslie Racecourse Drive
Remuera, Auckland 1051
Country [1] 269174 0
New Zealand
Other collaborator category [1] 260351 0
Individual
Name [1] 260351 0
Professor Robert Norman
Address [1] 260351 0
Robinson Institute
Ground Floor, Norwich Centre
55 King William Rd
North Adelaide
DX650517, The University of Adelaide 5005
South Australia
Country [1] 260351 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286179 0
Ethics committee address [1] 286179 0
Ethics committee country [1] 286179 0
Date submitted for ethics approval [1] 286179 0
01/12/2011
Approval date [1] 286179 0
Ethics approval number [1] 286179 0

Summary
Brief summary
Implantation of the embryo remains a key rate limiting step for successful outcome in an IVF/ICSI cycle in women with subfertility. Several small and heterogeneous studies have suggested that injury to the endometrium (lining of the uterus) prior to an IVF/ICSI cycle improves the clinical pregnancy rate or live birth rate.

The aim of this study is to determine whether a single endometrial biopsy prior to an IVF/ICSI cycle influences the live birth rate in women under 40 years of age who have failed to conceive a pregnancy despite having undergone at least 2 embryo transfers of reasonable quality embryos.

The study will be a large, single blind, randomised controlled trial with the above aim, whilst trying to control for many of the confounders present in previous small studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33403 0
Dr Phillip McChesney
Address 33403 0
Fertility Associates
PO Box 598
Hamilton
3240
Country 33403 0
New Zealand
Phone 33403 0
+64783923603
Fax 33403 0
Email 33403 0
[email protected]
Contact person for public queries
Name 16650 0
Dr Dr Phillip McChesney
Address 16650 0
Fertility Associates
Level 3, Ascot Central
7 Ellerslie Racecourse Drive,
Remuera, Auckland 1051
Country 16650 0
New Zealand
Phone 16650 0
+64 9 520 9520
Fax 16650 0
+64 9 520 9521
Email 16650 0
[email protected]
Contact person for scientific queries
Name 7578 0
Dr Dr Phillip McChesney
Address 7578 0
Fertility Associates
Level 3, Ascot Central
7 Ellerslie Racecourse Drive,
Remuera, Auckland 1051
Country 7578 0
New Zealand
Phone 7578 0
+64 9 520 9520
Fax 7578 0
+64 9 520 9521
Email 7578 0
[email protected]

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

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