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.: PACTR201306000461792 Date of Approval: 22/11/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
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 low responders infertile female in ICSI,Nutritional, Metabolic, Endocrine,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/06/2013
Actual trial start date 15/06/2013
Anticipated date of last follow up 14/06/2014
Actual Last follow-up date 14/06/2014
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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 method (block size 4, not variable) Sealed opaque envelops Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Growth hormone 1.3 mg 5 days Intramuscular injection of growht hormone "Genotropin" started from second day of cycle 100
Control Group Conventional 5 days Conventional antagonist stimulation protocol 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 Year(s) 45 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 01/01/2013 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
Hassan Aly Hassan Elmaghraby 649 Horryia Avenue Janaklis Alexandria #402 Egypt
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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Aly Hassa Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
City Postal code Country Position/Affiliation
Alexandria #402 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 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