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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.: PACTR201306000461792 Date registered: 2012/11/22
TRIAL DESCRIPTION
Public title Growth hormone with anatagonist in low responders
Official scientific title Effect of addition of growth hormone with GnRH antagonist in women above 40: randomized control trial.
Brief summary describing the background
and objectives of the trial
whether the addition of growth hormone can improve the probability of pregnancy in poor responders undergoing ovarian stimulation for in-vitro fertilization (IVF) has been examined to date by several studies. The aim of this study is to investigate whether supplementaiton of growth hormone to GnRH antagonist protocols could improve the cycle outcome in the terms of oocyte stimulation, endometrial thickness, fertilization rate, embryo quality and pregnancy at IVF in patients undergoing ICSI with GnRH antagonist protocols.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) d
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2013-06-15
Actual trial start date 2013-06-15
Anticipated date of last follow up 2014-06-14
Actual date of last follow up 2014-06-14
Anticipated target sample size (number of participants) 200   
Actual target sample size (number of participants) 200   
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 method (block size 4, not variable) Sealed opaque envelops Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Conventional 5 days Conventional antagonist stimulation protocol 100 Active
Experimental group Growth hormone 1.3 mg 5 days Intramuscular injection of growht hormone "Genotropin" started from second day of cycle 100

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Regular cycle 1. Antral follicle count (AFC) <4 2. Anti-mullarian hormone (AMH) <0.7 3. No response in a previous ICSI cycle 40 Years 45 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 2013/01/01 Libyan Medical Committe
Ethics Committee Address
Street address City Postal code Country
Libyan Arab Jamahiriya

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome clinical pregnancy with cardiac pulsation four weeks after embryo transfer
Secondary Outcome Number of ampoules of hMG during the whole stimulation cycle
Secondary Outcome cycle cancellation and the end of the stimulation
Secondary Outcome Aboration any time

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Misratta National Center for infertility treatment National Steel Company Compound Misratta Libyan Arab Jamahiriya

FUNDING SOURCES
Name of source Street address City Postal code Country
Misratta National Center for infertility treatment National Steel Company Compound Misratta 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 #402 Egypt University

COLLABORATORS
Name Street address City Postal code Country
Dalal Elgizery 649 Horryia Avenue Alexandria #402 Egypt
Ismail M. elfourteia National Steel Company Compound Misratta Libyan Arab Jamahiriya
Sherif Gafaar 14 of May street, El Sayadla Builds, building number 2 #501 Smouha, Alexandria Egypt
Eman Elgindy Apart 22, building 13, group 76, Rehab City Cairo Egypt
Awatif andisha salah, National Steel Company Compound Misratta Libyan Arab Jamahiriya
Hassan Aly Hassan Elmaghraby 649 Horryia Avenue Janaklis Alexandria #402 Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Hassan Aly Hassa Elmaghraby hassanmaghraby@gmail.com 002 01222137317 002 03 5855763
Street address City Postal code Country Position / Affiliation
649 Horryia Avenue Alexandria #402 Egypt Professor of Obstetrics and Gynaecology
Role Name Email Phone Fax
Scientific Enquiries Prof 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 002034251415
Street address City Postal code Country Position / Affiliation
30 Garden City Smouha Alexandria Egypt Patient Information Manager