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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: www.pactr.org

Trial no.: PACTR201308000582203 Date registered: 2013/07/04
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
Purpose of the trial Treatment
Anticipated trial start date 2013-09-01
Actual trial start date 2013-09-01
Anticipated date of last follow up 2014-08-30
Actual date of last follow up 2014-08-30
Anticipated target sample size (number of participants) 330   
Actual target sample size (number of participants) 330   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 Min age Max 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 Years 39 Years 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 2013/08/01 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
Shatby University Maternity Hospital PortSaid Street Alexandria Egypt
Benha ICSI center El Shroqhospital,Hasan Youssef Banha Egypt
Al-Banoon Fertility center 7 Alriad street, Kowmya area Zagazig 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 Fax
Scientific Enquiries Prof Hassan Aly Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 002 03 5855763
Street address City Postal code Country Position / Affiliation
649 Horryia Avenue Alexandria Egypt Professor of Obstetrics and Gynaecology
Role Name Email Phone Fax
Principal Investigator Prof Hassan Aly Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 002 03 5855763
Street address City Postal code Country Position / Affiliation
649 Horryia Avenue Alexandria Egypt Professor of Obstetrics and Gynaecology
Role Name Email Phone Fax
Public Enquiries Mr Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 002 03 5855763
Street address City Postal code Country Position / Affiliation
30 Garden City Smouha Alexandria Egypt Patient Information Manager