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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201605001611268 Date of Approval: 30/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of salpingectomy on ovarian response and ICSI outcome
Official scientific title Impact of salpingectomy on ovarian response and ICSI outcome : cohort study
Brief summary describing the background and objectives of the trial study the effect of salpingectomy on ovarian response and ICSI outcome and compare it with control group
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/06/2016
Actual trial start date
Anticipated date of last follow up 01/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
Randomised automated Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ICSI-ET one cycle one month ICSI post salpingectomy 100
Control Group ICSI-ET one cycle one month ICSI without prior salpingectomy 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 20-39 no endometrial lesion uterine pathology POR 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
Yes 01/04/2016 CUH
Ethics Committee Address
Street address City Postal code Country
Kasr alainy Cairo 11555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical pregnancy rate 6weeks gestation
Secondary Outcome ovarian response day of HCG
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital(CUH) Kasralainy Cairo 11555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CUH Kasralainy Cairo 11555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CUH Kasralainy Cairo 11555 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hala Nabil 160 King Faisal Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com 00201111765934 24 abdelrahman albarkoky -almanyal
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Awad m_oj_h@yahoo.com 00201005034393 9 Said zulfakar
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Hala Nabil fawzy.jana@yahoo.com 00201002412549 160 King Faiasl
City Postal code Country Position/Affiliation
Giza 12613 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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information