Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001003268p
Ethics application status
Submitted, not yet approved
Date submitted
4/06/2018
Date registered
14/06/2018
Date last updated
14/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
inflammatory markers of lining of womb in infertile women with dilated fallopian tube
Scientific title
Endometrial inflammatory markers in infertile women with hydrosalpinx
Secondary ID [1] 295092 0
nil
Universal Trial Number (UTN)
U1111-1215-1982
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endometritis 308152 0
salpingitis 308153 0
Condition category
Condition code
Reproductive Health and Childbirth 307195 307195 0 0
Fertility including in vitro fertilisation
Renal and Urogenital 307239 307239 0 0
Pelvic inflammatory disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Infertile women exposed to inflammation of fallopian tube causes inflammation of endometrium and causes failure of implantation and inability to conceive for at least 2 years ,women enrolled in study will investigated on admission by laboratory , histopathology and immunohistochemistry examination of endometrial biopsy done under general anesthesia .
Intervention code [1] 301426 0
Diagnosis / Prognosis
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306144 0
Histopathological inflammatory markers of endometritis assessed by presence of :leukocytic infiltration ,neutrophil, plasma cells, lymphocyte, basophile, eosinophil and microphages in endometrial biopsy taken from patient under general anesthesia ,at follicular phase (day5-8 of menstrual cycle).
Timepoint [1] 306144 0
once and immediately after enrolment and confirmed diagnosis of hydrosalpnix .
Primary outcome [2] 306145 0
hysteroscopic finding of endometritis assessed as presence of :oedema, hyperemia, microploypi or acute endometritis as microabcess, fluid pouring from corneal end of fallopian tube.
Timepoint [2] 306145 0
once and immediately after enrolment.
Secondary outcome [1] 347731 0
immunohistochemistry marker of endometritis using hysteroscopy guided biopsy as determined by interleukin-2 [IL-2 mRNA].
Timepoint [1] 347731 0
once and immediately after enrolment

Eligibility
Key inclusion criteria
Primary or secondary infertility due to tubal factor
Minimum age
25 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Infertility due to unknown reasons other than salpingitis,Female with one of the following endocrine abnormalities: polycystic ovary or hyperprolactinemia.Female presenting abnormal cervical cytological examination: HPV infection or atypical cell hyperplasia or more.Acute inflammation of the genital tract.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data collected were reviewed, coded, and statistical analysis of collected data will done by using SPSS program (statistical package of social science; SPSS Inc., Chicago, IL, USA) for Microsoft Windows.
A. Descriptive statistics:
Mean and standard deviation were calculated to measure central tendency and dispersion of quantitative data.
Number and percents wer calculated to describe qualitative data.
B. Analytic Statistics:
Comparing groups was done using :
Chi-square-test:for comparison of qualitative data
Student t test to determine the significance in the difference between two means
MannWhitney U test to determine the significance in the difference between two non parametric variables.
The level of significance was taken at p-value of <0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
30/10/2019
Actual
Date of last data collection
Anticipated
30/10/2019
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 10528 0
Egypt
State/province [1] 10528 0
cairo

Funding & Sponsors
Funding source category [1] 299674 0
University
Name [1] 299674 0
AlAzhar unversity hospital
Country [1] 299674 0
Egypt
Primary sponsor type
Hospital
Name
Alzhraa unversity hospital
Address
1 Almokhaym eldaem street,Nasr city ,cairo
PO box:11751
Country
Egypt
Secondary sponsor category [1] 299008 0
Individual
Name [1] 299008 0
nahed allam
Address [1] 299008 0
Alzhraa university hospital
1 Almokhaym eldaem street,Nasr city ,cairo
PO box:11751
Country [1] 299008 0
Egypt

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300573 0
ethical committee of OBS/Gyn department, Al-Azhar university
Ethics committee address [1] 300573 0
Alzhaa university hospital
Almostashfa elyuonany street,Abassia ,cairo
Ethics committee country [1] 300573 0
Egypt
Date submitted for ethics approval [1] 300573 0
20/04/2018
Approval date [1] 300573 0
Ethics approval number [1] 300573 0

Summary
Brief summary
It is possible that the deleterious effect of hydrosalpinx fluid may not be limited to direct embryotoxicity, and may, in fact, be the result of an induced inflammatory response within the endometrial cavity. By evaluating inflammatory mediators and by analyzing the number and type of infammatory cells in the endometrium of patients with hydrosalpinges, we aim to determine whether there is an endometrial contribution to the compromised reproductive outcome in those patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84094 0
Dr Nahed Allam
Address 84094 0
Alzhraa university hospital
1 Almostashfa alyuonany street ,abassia ,cairo
Country 84094 0
Egypt
Phone 84094 0
+201121116136
Fax 84094 0
Email 84094 0
[email protected]
Contact person for public queries
Name 84095 0
Dr Nahed Allam
Address 84095 0
Alzhraa university hospital
1 Almostashfa alyuonany street ,abassia ,cairo
Country 84095 0
Egypt
Phone 84095 0
+201121116136
Fax 84095 0
Email 84095 0
[email protected]
Contact person for scientific queries
Name 84096 0
Dr Nahed Allam
Address 84096 0
Alzhraa university hospital
1 Almostashfa alyuonany street ,abassia ,cairo
Country 84096 0
Egypt
Phone 84096 0
+201121116136
Fax 84096 0
Email 84096 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.