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Trial registered on ANZCTR


Registration number
ACTRN12611001227987
Ethics application status
Approved
Date submitted
27/11/2011
Date registered
30/11/2011
Date last updated
30/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The importance of nerve fibers and macrophage cell count in the diagnosis of endometriosis
Scientific title
The importance of nerve fibers and macrophage cell count in the diagnosis of endometriosis
Secondary ID [1] 273478 0
'Nil'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 279266 0
Condition category
Condition code
Reproductive Health and Childbirth 279464 279464 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Endometrial nerve fibers and macrophage cell count using endometrial biopsy. Just before the patient's planned operation starts, endometrial biopsies are taken. This is done with the help of an endometrial sampling cannula. This procedure is done only once and after the induction of anesthesia and takes approximately 5 minutes. Also some patients who are previously operated and have endometrial samples kept in the pathology lab are involved in the study.
Intervention code [1] 283793 0
Diagnosis / Prognosis
Comparator / control treatment
Control group consists of biopsies and endometrial samples of patients who are not diagnosed to have endometriosis during operation.
Control group
Active

Outcomes
Primary outcome [1] 286023 0
Increase in the number of endometrial nerve fibers
Timepoint [1] 286023 0
After all biopsies are taken, all of the samples are evaluated together
Secondary outcome [1] 295013 0
Increase in the number of endometrial macrophage cells
Timepoint [1] 295013 0
After all biopsies are taken, all of the samples are evaluated together

Eligibility
Key inclusion criteria
Cystoma ovarii, chronic pelvic pain, infertility, myoma uteri, tubal ligation,
Minimum age
24 Years
Maximum age
47 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Malignancy, adenomyosis

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)
"Allocation is not concealed"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking 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 outside Australia
Country [1] 3979 0
Turkey
State/province [1] 3979 0

Funding & Sponsors
Funding source category [1] 284268 0
Self funded/Unfunded
Name [1] 284268 0
Address [1] 284268 0
Country [1] 284268 0
Primary sponsor type
Individual
Name
Cihan Cetin
Address
AYDINCIK DEVLET HASTANESI KADIN HAST. VE DOGUM POLIKLINIGI AYDINCIK/MERSIN/TURKEY
Country
Turkey
Secondary sponsor category [1] 283220 0
None
Name [1] 283220 0
Address [1] 283220 0
Country [1] 283220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286228 0
ISTANBUL UNIVERSITESI ISTANBUL TIP FAKULTESI KLINIK ARASTIRMALAR ETIK KURULU
Ethics committee address [1] 286228 0
Ethics committee country [1] 286228 0
Turkey
Date submitted for ethics approval [1] 286228 0
Approval date [1] 286228 0
Ethics approval number [1] 286228 0

Summary
Brief summary
The aim of the study is to determine whether the detection of nerve fibers and increased number of macrophage cells in the layer of endometrium can be used in the diagnosis of endometriosis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33446 0
Address 33446 0
Country 33446 0
Phone 33446 0
Fax 33446 0
Email 33446 0
Contact person for public queries
Name 16693 0
Cihan Cetin
Address 16693 0
Aydincik Devlet Hastanesi Kadin Hastaliklari ve Dogum Klinigi
Aydincik/Mersin/Turkey
Country 16693 0
Turkey
Phone 16693 0
+905332241033
Fax 16693 0
Email 16693 0
cihancetin00@yahoo.com
Contact person for scientific queries
Name 7621 0
Cihan Cetin
Address 7621 0
Aydincik Devlet Hastanesi Kadin Hastaliklari ve Dogum Klinigi
Aydincik/Mersin/Turkey
Country 7621 0
Turkey
Phone 7621 0
+905332241033
Fax 7621 0
Email 7621 0
cihancetin00@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary