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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
Gender
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
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] 6572 0
Egypt
State/province [1] 6572 0
alexandria

Funding & Sponsors
Funding source category [1] 290479 0
Self funded/Unfunded
Name [1] 290479 0
Address [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
galal_af@yahoo.com
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
galal_af@yahoo.com
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
galal_af@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