Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000434594
Ethics application status
Approved
Date submitted
29/12/2014
Date registered
6/05/2015
Date last updated
6/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
uterine cavity abnormalities in endometriosis
Scientific title
Uterine cavity abnormalities in women with endometriosis: association or causal relation?
Secondary ID [1] 285895 0
no
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endometriosis 293818 0
Condition category
Condition code
Reproductive Health and Childbirth 294121 294121 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
Office hysteroscopy will be done for examination of the uterine cavity in all included women with endometriois (that was confirmed using laparoscopy either in the same setting or in a previous one) for any abnormal pathology like uterine septum , endometrial polyp and contracted cavity .

Office hysteroscopy will be done once from day five to eight of menstrual cycle
Intervention code [1] 290877 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293921 0
diagnosis of uterine abnormalities such as endometrial polyp, uterine septum
Timepoint [1] 293921 0
this will be diagnosed using the office hystroscopy in early days of follicular phase of he menstrual cycle from day 5 to day 8.
Secondary outcome [1] 312154 0
N/A
Timepoint [1] 312154 0
n/a

Eligibility
Key inclusion criteria
1- Age should be between 15-40 years.
2- Diagnosis of endometriosis either by laparoscopy or clear ultrasound evidence
Minimum age
15 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Patients that have any previous surgery of the intra uterine cavity.
2- Patients receiving any hormonal treatment for at least 6 months.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/01/2015
Actual
14/01/2015
Date of last participant enrolment
Anticipated
17/04/2015
Actual
15/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 6572 0
Egypt
State/province [1] 6572 0
alexandria

Funding & Sponsors
Funding source category [1] 290479 0
Self funded/Unfunded
Name [1] 290479 0
Country [1] 290479 0
Primary sponsor type
University
Name
alexandria university egypt
Address
22 elgeish street , elshatby
Alexandria , egypt
21526
Country
Egypt
Secondary sponsor category [1] 289183 0
None
Name [1] 289183 0
Address [1] 289183 0
Country [1] 289183 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292147 0
ethical committee , faculty of medicine ,alexandria university
Ethics committee address [1] 292147 0
Champollion Street

El-Khartoum Square

Azarita Medical Campus alexandria egypt
21526
Ethics committee country [1] 292147 0
Egypt
Date submitted for ethics approval [1] 292147 0
Approval date [1] 292147 0
26/11/2014
Ethics approval number [1] 292147 0
IRB NO 00007555-FWA NO 00018699

Summary
Brief summary
this study will be conducted to evaluate the association of uterine cavity abnormalities with pelvic endometriosis using office hysteroscopy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53730 0
Prof ahmed fawzy galal
Address 53730 0
Elshatby maternity university hospital port saeed street alexandria Egypt 21526
Country 53730 0
Egypt
Phone 53730 0
+201222286962
Fax 53730 0
Email 53730 0
[email protected]
Contact person for public queries
Name 53731 0
Prof ahmed fawzy galal
Address 53731 0
Elshatby maternity university hospital port saeed street alexandria Egypt 21526
Country 53731 0
Egypt
Phone 53731 0
+201222286962
Fax 53731 0
Email 53731 0
[email protected]
Contact person for scientific queries
Name 53732 0
Prof ahmed fawzy galal
Address 53732 0
Elshatby maternity university hospital port saeed street alexandria Egypt 21526
Country 53732 0
Egypt
Phone 53732 0
+20122286962
Fax 53732 0
Email 53732 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

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

Documents added automatically
No additional documents have been identified.