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.: PACTR201308000582203 Date of Approval: 04/07/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adding Letrozole to antagonist protocol in second ICSI attempt
Official scientific title Effect of adding letrozole to antagonist protocol for second ICSI attempt: A randomized controlled trial
Brief summary describing the background and objectives of the trial Aaromatase inhibitors have been used successfuly in ovulation induction. Low responses in ICSI were improved by the addition of letrozole to stimulation protocol. In good responders endometrial thickness and implanatation were better with addirton of letrozole to antagonist protocol. In good responders undergoing second ICSI trial it is not known whether letrozole added to a fixed antagonist protocol will have a beneficial effect or not, this is the scope of the current RCT.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Women scheduled to second trial ICSI
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2013
Actual trial start date 01/09/2013
Anticipated date of last follow up 30/08/2014
Actual Last follow-up date 30/08/2014
Anticipated target sample size (number of participants) 330
Actual target sample size (number of participants) 330
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 Permuted block randomisation (block size of 4, not variable) Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Letrozole 2.5 mg 5 days 2.5 mg letrozole orally once daily for 5 days starting day 2 of ICSI cycle added to a fixed antagonist protocol 165
Control Group Control Fixed antagonist protocol 165 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Failed one attempt of ICSI in good responders (more than 3 Class A embryo transfer). Poor response to ovarian stimulation as defined by ESHRE consensus (the Bologna criteria) (2011) 18 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 01/08/2013 Medical Ethical Committe of Misrata National Center for infertility Management
Ethics Committee Address
Street address City Postal code Country
LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical pregnancy with cardiac pulsation Four weeks after ET
Secondary Outcome Blastocyst formation Day 5 of ICSI
Secondary Outcome Spontaneous miscarriage Up to 20 weeks pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha ICSI center El Shroqhospital,Hasan Youssef Banha Egypt
Al-Banoon Fertility center 7 Alriad street, Kowmya area Zagazig Egypt
Shatby University Maternity Hospital PortSaid Street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Misrata National Center for infertility management LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof Dr Hassa Aly Hassan Elmaghraby 649 Horryia Avenue Janaklis Alexandria Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hassan Aly Hassan Elmaghraby 649 Horryia Avenue Janaklis Alexandria Egypt
Ismail M. elfourteia LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
Eman Elgindy Apart 22, building 13, group 76, Rehab City Cairo Egypt
Amina Abdul Fatah Habara LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
Ahmed Youssef Rizk El Shroq hospital,Hasan Youssef st Banha Egypt
Sherif Gaafar 14 of May street, El Sayadla Builds, building number 2 #501 Smouha, Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Aly Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Hassan Aly Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Obstetrics and Gynaecology
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