Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000001594
Ethics application status
Approved
Date submitted
11/12/2014
Date registered
6/01/2015
Date last updated
6/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are endometrial nerve fibres unique to endometriosis? A prospective case control study of endometrial biopsy as a diagnostic test for endometriosis in women with pelvic pain.
Scientific title
Is endometrial biopsy and nerve fibre staining able to predict which patients will have endometriosis in a sample of women with pelvic pain undergoing laparoscopy at Mercy Hospital for Women?
Secondary ID [1] 285830 0
Nil
Universal Trial Number (UTN)
U1111-1165-1141
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 293747 0
Chronic Pelvic Pain 293748 0
Condition category
Condition code
Reproductive Health and Childbirth 294047 294047 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be women of reproductive age who are already scheduled to undergo laparoscopy and endometrial biopsy as part of the investigation of their pain. We will take two endometrial biopsies (curettings + endometrial biopsy with endosampler) and do immunostaining with PGP9.5, we will look for the presence of fine nerve fibres in the endometrium in all participants. Both specimens will be taken on a single occaison during the scheduled laparoscopy.
Intervention code [1] 290809 0
Not applicable
Comparator / control treatment
The control group will be women undergoing laparoscopy who are confirmed NOT to have endometriosis after examination of the pelvis and biopsy of any suspicious lesions. The control group will also have nerve fibre assessment performed on their endometrial samples.
Control group
Active

Outcomes
Primary outcome [1] 293824 0
Presence or absence of fine nerve fibres in the endometrium. The specimens will be immunostained with PGP9.5. A pathologist, blinded to the subject's endometriosis status will examine the slides using microscopic analysis and determine them to be Positive (nerve fibres present) or Negative (nerve fibres absent).
Timepoint [1] 293824 0
The outcome is measured in the laboratory after specimen collection.
Secondary outcome [1] 311949 0
As a composite secondary outcome the concentration of nerve fibres in all the positive specimens will be calculated with microscopic analysis and individual nerve fibre counting. A comparison will be made between nerve fibre density and the patients level of pain, as measured on a visual analog scale.
Timepoint [1] 311949 0
Nerve fibre counts will be performed after immunostaining, by two pathologists blinded to the subject's endometriosis status. The patient's pain scores will be obtained on the day of surgery, prior to laparoscopy and expressed as a VAS for dysmenorrhoea, non cyclic pelvic pain and dyspareunia.

Eligibility
Key inclusion criteria
Woman booked for laparoscopy and endometrial biopsy at the Mercy Hospital for women. not taking any exogenous hormone preparations, and who has a VAS (visual analog score) of at least 3/10 for dysmenorrhoea (pain with periods) and/or pelvic pain (acyclic pelvic pain) and/or dyspareunia (pain with sexual intercourse)
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Woman unhappy to have two endometrial biopsies taken (curettings plus endometrial biopsy with endosamppler), woman taking exogenous hormones, a woman booked for laparoscopy who does not have any pain.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
This is a pilot study. No sample size calculation has been performed as it is unknown if endometrial biopsy is able to diagnose endometriosis. We based our sample size on two previously published papers that used 20 patients in each arm. (20 with endometriosis, 20 without endometriosis) and did nerve fibre staining on the whole group's endometrium.
. Frequency tables will be constructed and the association examined using a chi-square test. Sensitivity, specificity, positive and negative predictive values and 95% confidence intervals will be calculated for both curettings and biopsy. Quality of curettage and biopsy specimens will be cross-tabulated with number of fibres and the association examined using the gamma statistic. The relationship between number of fibres and pain scores will be examined using scatter plots and correlation co-efficients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
26/10/2009
Date of last participant enrolment
Anticipated
30/12/2012
Actual
6/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3257 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 9052 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 290402 0
Charities/Societies/Foundations
Name [1] 290402 0
Medical Research Foundation for Women and Babies.
Country [1] 290402 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women - Heidelberg
Address
163 Studley Rd
Heidelberg
VIC 3084
Country
Australia
Secondary sponsor category [1] 289121 0
None
Name [1] 289121 0
Address [1] 289121 0
Country [1] 289121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292095 0
Mercy Health Human Research Ethics Committee (Mercy Health HREC)
Ethics committee address [1] 292095 0
163 Studley Rd
Heidelberg
VIC 3084
Ethics committee country [1] 292095 0
Australia
Date submitted for ethics approval [1] 292095 0
Approval date [1] 292095 0
21/06/2009
Ethics approval number [1] 292095 0
R09/05, ammended ethics R14-13

Summary
Brief summary
There is currently no non invasive way to diagnose endometriosis. The gold standard is laparoscopy plus directed biopsy. Previous studies have suggested that endometrial nerve fibre detection may function as a less invasive outpatient test of endometriosis. This work suggested that if fine nerve fibres (C type unmyelinated) are present in the functional layer of the endometrium then the patient has endometriosis and if the fibres are not present the patient does not have endometriosis. We wish to recruit women with pelvic pain as we wonder if the nerve fibres relate to the painful condition rather than to endometriosis. We will perform endometrial nerve fibre detection in 20 women with pain and no endometriosis and 20 women with pain who have endometriosis.

Our hypothesis is that fine nerve fibres will be found in the functional layer of the endometrium in women both with and without endometriosis who also have pelvic pain. Thus endometrial nerve fibre detection is not a useful way to diagnose endometriosis.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 257 257 0 0
/AnzctrAttachments/367603-R14-13 Clean copy of updated PICF.doc
Attachments [2] 258 258 0 0
/AnzctrAttachments/367603-new study protocol .doc
Attachments [3] 259 259 0 0
/AnzctrAttachments/367603-ethics approval.pdf

Contacts
Principal investigator
Name 53470 0
Dr Lenore Ellett
Address 53470 0
Mercy Hospital
163 Studley Rd
Heidelberg
VIC 3084
Country 53470 0
Australia
Phone 53470 0
+61, 03, 84584444
Fax 53470 0
+61 03 8458 4889
Email 53470 0
lellett@mercy.com.au
Contact person for public queries
Name 53471 0
Dr Lenore Ellett
Address 53471 0
Department of Endosurgery
Mercy Hospital for Women
163 Studley Rd
Heidelberg
VIC 3084
Country 53471 0
Australia
Phone 53471 0
+61 03 8458 4444
Fax 53471 0
+61 03 8458 4889
Email 53471 0
lenore@crosbie.com.au
Contact person for scientific queries
Name 53472 0
Dr Lenore Ellett
Address 53472 0
Department of Endosurgery
Mercy Hospital for Women
163 Studley Rd
Heidelberg
VIC 3084
Country 53472 0
Australia
Phone 53472 0
+61 03 8458 4444
Fax 53472 0
+61 03 8458 4889
Email 53472 0
lenore@crosbie.com.au

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

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3983Plain language summaryNo Our study does not support the detection of endome... [More Details]
4504Study results articleYes October 15, 2015 Human Reproduction Ellett L, R... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAre endometrial nerve fibres unique to endometriosis? A prospective case-control study of endometrial biopsy as a diagnostic test for endometriosis in women with pelvic pain.2015https://dx.doi.org/10.1093/humrep/dev259
N.B. These documents automatically identified may not have been verified by the study sponsor.