ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1165-1141

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Endometriosis

Chronic Pelvic Pain

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]

The outcome is measured in the laboratory after specimen collection.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Mercy Hospital for Women - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Medical Research Foundation for Women and Babies.

Address [1]

Level 1, 380 Victoria Pde
East Melbourne
VIC 3002

Country [1]

Australia

Primary sponsor type

Hospital

Name

Mercy Hospital for Women - Heidelberg

Address

163 Studley Rd
Heidelberg
VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mercy Health Human Research Ethics Committee (Mercy Health HREC)

Ethics committee address [1]

163 Studley Rd
Heidelberg 
VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/06/2009

Ethics approval number [1]

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]

/AnzctrAttachments/367603-R14-13 Clean copy of updated PICF.doc

Attachments [2]

/AnzctrAttachments/367603-new study protocol .doc

Attachments [3]

/AnzctrAttachments/367603-ethics approval.pdf

Contacts

Principal investigator

Name

Dr Lenore Ellett

Address

Mercy Hospital
163 Studley Rd
Heidelberg
VIC 3084

Country

Australia

Phone

+61, 03, 84584444

Fax

+61 03 8458 4889

lellett@mercy.com.au

Contact person for public queries

Name

Lenore Ellett

Address

Department of Endosurgery
Mercy Hospital for Women
163 Studley Rd
Heidelberg
VIC 3084

Country

Australia

Phone

+61 03 8458 4444

Fax

+61 03 8458 4889

lenore@crosbie.com.au

Contact person for scientific queries

Name

Lenore Ellett

Address

Department of Endosurgery
Mercy Hospital for Women
163 Studley Rd
Heidelberg
VIC 3084

Country

Australia

Phone

+61 03 8458 4444

Fax

+61 03 8458 4889

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Our study does not support the detection of endome... [More Details]
Study results article	Yes		October 15, 2015 Human Reproduction Ellett L, R... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	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.	2015	https://dx.doi.org/10.1093/humrep/dev259

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically