Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201709002555574 Date of Registration: 25/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title transvaginal aspiration of hydrosalpinx
Official scientific title impact of transvagianl aspiration of hydrosalpinx on ICSI outcome :RCT
Brief summary describing the background and objectives of the trial at day of oocyte retrieval we will do aspiration of hydrosalpinx and study the effect of this procedure on Ongoing pregnancy rate
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ART,Infections and Infestations,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female,HIV/AIDS
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/09/2017
Actual trial start date 01/09/2017
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date 01/01/2019
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TV aspiration group once at time of OPU aspiration of txic fluid 75
Control Group no aspiration none none no aspiration 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 20-39 years active PID 20 Year(s) 39 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/09/2017 CUH ethical committee
Ethics Committee Address
Street address City Postal code Country
kasralainy st Cairo 11555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ongoing pregnancy rate 12 weeks pregnancy
Secondary Outcome CPR and implantation rate 6weeks pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital kasralainy st Cairo 11555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CUH kasralainy st Cairo 11555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CUH kasralainy st Cairo 11555 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Cairo university kasralainy st Cairo 11555 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com 01111765934 4A-19 division 3 zahraa almaady
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Mohammed Awad m_oj_h@yahoo.com 01005034393 9said zulfakar st
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Adel Nada adel.nada29@gmail.com 01111765934 4A-19 division 3 zahraa almaady
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information