Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000760279p
Ethics application status
Submitted, not yet approved
Date submitted
30/04/2018
Date registered
7/05/2018
Date last updated
7/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Hystroscopy versus laparoscopy use for tubal disconnection in cases of Fallopian tube dilatation before assisted reproduction .
Scientific title
Hysteroscopic versus laparoscopic tubal disconnection in infertile women with hydrosalpinges prior to IVF or ICSI to increase pregnancy rate
Secondary ID [1] 294755 0
none
Universal Trial Number (UTN)
U1111-1213-1486
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fallopian tube dilatation 307652 0
Condition category
Condition code
Reproductive Health and Childbirth 306717 306717 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hysteroscopic unilateral or bilateral fallopian tube bipolar electrocoagulation by roller ball or insertion of Essure coil by gynaecology surgeon aiming to disconnect the diseased tube for women with fallopian tube dilatation as the only cause of infertility 1 month prior to assisted reproduction procedure as IVF or ICSI, to increase pregnancy rate.
Intervention code [1] 301052 0
Treatment: Surgery
Comparator / control treatment
Laparoscopic electrocoagulation fallopian tube disconnection or salpingectomy by gynaecology surgeon aiming to disconnect the diseased tube for women with fallopian tube dilatation as the only cause of infertility prior to assisted reproduction procedure as IVF or ICSI, to increase pregnancy rate.
Control group
Active

Outcomes
Primary outcome [1] 305717 0
serum pregnancy test positive
Timepoint [1] 305717 0
3 months post procedure
Primary outcome [2] 305718 0
proved early by fetal viability detection by transvaginal ultrasound.
Timepoint [2] 305718 0
10 weeks post surgery
Secondary outcome [1] 346232 0
Intraoperative bleeding diagnosed directly and controlled by laparoscopy doctor instantly.
Timepoint [1] 346232 0
instantly and continuously throughout surgery and recorded in operative finding sheet.
Secondary outcome [2] 346233 0
failed implantation rate assessed by serum pregnancy test
Timepoint [2] 346233 0
2 weeks post ICSI or IVF procedure.
Secondary outcome [3] 346234 0
miscarriage rate assessed by a pregnancy test and transvaginal ultrasound
Timepoint [3] 346234 0
4 weeks post ICSI or IVF procedure.
Secondary outcome [4] 346305 0
failure of the procedure due to adhesion or tight cervix diagnosed on the spot by direct observation done by a surgeon and recorded in the operative sheet
Timepoint [4] 346305 0
'Assessed instantly and continuously throughout surgery and reported by the surgeon in the patient operative sheet.

Eligibility
Key inclusion criteria
women with uni- or bilateral ultrasound visible hydrosalpinex confirmed by hystro-salpingography who are scheduled for an IVF/ICSI treatment ,BMI <35 kg/m2 ,All patients had regular menses ,Normal hormonal profile,Normal semen analyses of the husband
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with other causes of infertility other than tubal factor ,Contraindication to laparoscopy
or hystroscopy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using shuffling card
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
According to G power calculator 3.0.10
t-tests, Means: Difference between two independent means (two groups)
Analysis: A priori: Compute required sample size
Input: Tail(s) = One
Effect size d = 0.5
a err prob = 0.05
Power (1-ß err prob) = 0.8
Allocation ratio N2/N1 = 1
Output: Noncentrality parameter d = 2.524876
Critical t = 1.660234
Df = 100
Sample size group 1 = 51
Sample size group 2 = 51
Total sample size = 102
Actual power = 0.805899

Quantitative data will be expressed as the mean ± standard deviation (SD), Median and I-Q range for non-parametric data and compared using Student t-test or Mann–Whitney U test, as appropriate.Qualitative data will be expressed as frequency and percentage and compared via t-test or Fisher exact test, as appropriate. Pearson or Spearman correlation for categorical or continuous data.P < 0.05 was considered to be statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment outside Australia
Country [1] 10360 0
Egypt
State/province [1] 10360 0
cairo

Funding & Sponsors
Funding source category [1] 299360 0
Hospital
Name [1] 299360 0
Alzharaa university hospital
Country [1] 299360 0
Egypt
Primary sponsor type
Hospital
Name
Alzharaa uinversity hospital
Address
Elmostashfa elyounany street ,abassia,cairo,Egypt
Country
Egypt
Secondary sponsor category [1] 298635 0
University
Name [1] 298635 0
AlAzhar university
Address [1] 298635 0
Almokhaym eldaem street,nasr city,cairo,Egypt
Country [1] 298635 0
Egypt

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300265 0
Alazhar facaulty of medicine medical etical committee
Ethics committee address [1] 300265 0
Ethics committee country [1] 300265 0
Egypt
Date submitted for ethics approval [1] 300265 0
29/04/2018
Approval date [1] 300265 0
Ethics approval number [1] 300265 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70314 0
Dr Nahed Ezzat Allam
Address 70314 0
Alzharaa university hospital,
Almostshfa elyounany street, abasia ,Cairo,
Postcode :11751
Country 70314 0
Egypt
Phone 70314 0
+201121116136
Fax 70314 0
Email 70314 0
[email protected]
Contact person for public queries
Name 70315 0
Nahed Ezzat Allam
Address 70315 0
Alzharaa university hospital,
Almostshfa elyounany street,abasia ,Cairo,
postcode: 11751
Country 70315 0
Egypt
Phone 70315 0
+201121116136
Fax 70315 0
Email 70315 0
[email protected]
Contact person for scientific queries
Name 70316 0
Nahed Ezzat Allam
Address 70316 0
Alzharaa university hospital,
Almostshfa elyounany street, abasia , Cairo,
postcode: 11751
Country 70316 0
Egypt
Phone 70316 0
+201121116136
Fax 70316 0
Email 70316 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.