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.: PACTR201602001467322 Date of Approval: 10/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title effect of laser hatching in endometriosis
Official scientific title Effect of laser assisted zona thinning during assisted reproduction on pregnancy outcome in women with endometriosis
Brief summary describing the background and objectives of the trial we will study effect of laser assissted hatching in IVF_ET cycles in patient confirmed to have endometriosis
Type of trial RCT
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 01/03/2016
Actual trial start date 01/03/2016
Anticipated date of last follow up 01/03/2017
Actual Last follow-up date 01/05/2017
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group laser assissted hatching group once at time of transfer laser thining of zona 50
Control Group non laser assissted group once at time of transfer ET without zona thining 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 20-39 years more than one embryo grade one available age >40 years only one grade one embryo or no grade3 one embryo 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 01/01/2016 Gannah ethical commitee
Ethics Committee Address
Street address City Postal code Country
52 shehab st cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome implantation rate 6 weeks gestation
Secondary Outcome clinical pregnancy rate 6weeks gestation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gannah IVF center 52 shehab st Cairo 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Gannah IVF center 52 shehab st Cairo 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Gannah IVF center 52 shehab st Cairo 12613 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Fatma Hassan manyal Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com +201111765934 24 Abdelrahman Albarkoky-Amanyal
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Awad m_oj_h@yahoo.com +201005034393 9 zulfakar st
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Awad m_oj_h@yahoo.com +201005034393 9 zulfakar st
City Postal code Country Position/Affiliation
Cairo 11553 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