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Trial registered on ANZCTR


Registration number
ACTRN12606000052538
Ethics application status
Approved
Date submitted
1/02/2006
Date registered
6/02/2006
Date last updated
19/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of endosampler as a tool for diagnosing endometriosis in comparison with endometrial currettage
Scientific title
Pilot study to evaluate the efficacy of endosampler as a tool for diagnosing endometriosis in comparison with endometrial currettage to identify endometrial nerve fibers by staining the obtained endometrial biopsies with Polyclonal rabbit anti-protein gene product (PGP9.5) of unmyelinated endometrial nerve fibres
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 1016 0
Condition category
Condition code
Reproductive Health and Childbirth 1092 1092 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two interventions will be done:
1- endometrial biopsy using MedGyn EndoSampler(Distributed by IPAS. Manufactured by MedGYn).
2-endometrial biopsy using curetting
The Endosampler:
Is a sterile disposable curette for sampling endometrium aids to obtain differentiated endometrial tissue without anaesthesia. Except for rare instances it does not need cervical block. It has 3mm cannula with sharp sluts to ensure better sampling which attached to 10 mm syringe.
This pilot study will be conducted by recruiting 20 women known to have endometriosis but not recently on treatment for endometriosis. Two questioners will be filled; one by the woman herself stating her past medical history and cycle history; other one will be filled by treating doctor documenting woman’s medical history, clinical and laboratory findings. After obtaining an informed consent from the woman, an endometrial biopsies will be obtained by endometrial curettage and endosampler in theater during laparoscopy and D&C usually within one month after obtaining consent. The two biopsies will be stained by PGP9.5 to look for endometrial nerve fibers. A comparison between the two biopsies will be done to see if endosampler is successful as endometrial curettage in identifying these nerve fibers.
Intervention code [1] 855 0
Diagnosis / Prognosis
Comparator / control treatment
Women without endometriosis
Control group
Active

Outcomes
Primary outcome [1] 1457 0
The presence of nerve fibers in the endometrium of women with endometriosis using PGP 9.5 staining technique after obtaining biopsies by both endosampler and endometrial curettage
Timepoint [1] 1457 0
one week
Primary outcome [2] 1458 0
Explore the ability of Endosampler in picking up these endometrial nerve fiber in comparison to endometrial curettage
Timepoint [2] 1458 0
one week. The staining will be done in one week time after both biopcies are taken
Secondary outcome [1] 2610 0
Two questioners will be filled at the time of first interview at the clinic; one by the woman herself stating her past medical history and cycle history; other one will be filled by treating doctor documenting woman’s medical history, clinical and laboratory findings.
Timepoint [1] 2610 0
Both questionnaires will take 30 minutes to fill. A qualitative analysis will be done after finishing the study. The expected time between the first interview and the interventions is one month.

Eligibility
Key inclusion criteria
1-Women in any reproductive age.2-Women known to have endometriosis but not receiving any medical treatment.3-Women undergoing laparoscopy to confirm endometriosis.
Minimum age
15 Years
Maximum age
52 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1-Women on hormonal treatment.2-Women not having endometriosis.3-Women underwent endometrial ablation.4-Women with history of cervical stenosis.5-Women refusing to have endosampler.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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)

Funding & Sponsors
Funding source category [1] 1194 0
University
Name [1] 1194 0
Department of O&G Univesity of Sydney
Address [1] 1194 0
The Queen Elizabeth II Research Institute for Mothers and Infants Univesity of Sydney D02 Camperdown NSW 2006
Country [1] 1194 0
Australia
Primary sponsor type
University
Name
Department of O&G Univesity of Sydney
Address
The Queen Elizabeth II Research Institute for Mothers and Infants Univesity of Sydney D02 Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 1055 0
None
Name [1] 1055 0
none
Address [1] 1055 0
Country [1] 1055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2516 0
Ethics Review Committee (RPAH Zone) of the Sydney South West Area Health Service
Ethics committee address [1] 2516 0
Ethics committee country [1] 2516 0
Australia
Date submitted for ethics approval [1] 2516 0
Approval date [1] 2516 0
19/12/2005
Ethics approval number [1] 2516 0
X05-0345
Ethics committee name [2] 2517 0
Royal Prince Alfred Hospital & Royal Prince Alfred Medical Centre
Ethics committee address [2] 2517 0
Ethics committee country [2] 2517 0
Australia
Date submitted for ethics approval [2] 2517 0
Approval date [2] 2517 0
Ethics approval number [2] 2517 0

Summary
Brief summary
A research study into the gynaecological disease called endometriosis. Endometriosis affects 10 -15% of reproductive women. It can cause painful periods and painful intercourse, infertility and irregular bleeding. The cause of the disease is still unknown and the diagnosis of endometriosis is only possible with surgery. Women who are known to have endometriosis and those whose symptoms suggest that they may have endometriosis are being invited to participate in our study.
The objective of our study is to investigate whether a device called Endosampler can be used to diagnose endometriosis by picking up small nerve fibres in the lining of the womb .Our preliminary studies suggest that these nerve fibres play a role in pain generation associated with endometriosis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35832 0
Address 35832 0
Country 35832 0
Phone 35832 0
Fax 35832 0
Email 35832 0
Contact person for public queries
Name 10044 0
Dr Moamar Al-Jefout
Address 10044 0
The Queen Elizabeth II Research Institute for Mothers and Infants
Univesity of Sydney
D02
Camperdown NSW 2006
Country 10044 0
Australia
Phone 10044 0
+61 2 93512478 Mobile: +61 404360140
Fax 10044 0
+61 2 93514560
Email 10044 0
moal4176@mail.usyd.edu.au
Contact person for scientific queries
Name 972 0
Professor Fraser IS
Address 972 0
The Queen Elizabeth II Research Institute for Mothers and Infants
Univesity of Sydney
D02
Camperdown NSW 2006
Country 972 0
Australia
Phone 972 0
+61 2 93512478
Fax 972 0
+61 2 93514560
Email 972 0
helena@med.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
No Results