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.: PACTR201503001061298 Date of Approval: 07/03/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title androcure versus long protocol
Official scientific title pretreatment by androcure and estradiol versus luteal agonist in IVF cycles
Brief summary describing the background and objectives of the trial use of of androcure and estradiol as cheap method for pituitary supression prior to antagonist protocol in IVF
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infertility,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2014
Actual trial start date 01/03/2015
Anticipated date of last follow up 01/09/2016
Actual Last follow-up date 01/09/2016
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants) 100
Recruitment status Completed
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group long luteal agonist protocol daily SC injection decapeptyl0.1mg long luteal protocol 50 Active-Treatment of Control Group
Experimental Group androcure and estradiol one tablet of both from day21 for one week one week oral pituitary supression 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
IVF patients from age 20-40years patients with medical disease that is contraindictes IVF or pregnancy 20 Year(s) 40 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 local ethical comittee
Ethics Committee Address
Street address City Postal code Country
Kasr alainy ST Cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pregnancy rate pregnancy test 2 weeks after ET
Secondary Outcome GN dose dose use up to day of hcg
Secondary Outcome ovulation induction and fertilization outcom ovulation parameter and fertilization outcome during and after Hcg
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital Kasr Alainy ST Cairo 12613 Egypt
private IVF center shehab st Cairo 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University Nahdet Masr Square Giza 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university nahdet masr square giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Hammam 9 said zulfakar Cairo 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com +201111765934 24 abdelrahman elbarkoky
City Postal code Country Position/Affiliation
cairo 1613 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Mohammed Awad m_oj_h@yahoo.com +201005034393 9 said zulfakar st
City Postal code Country Position/Affiliation
Cairo 12613 Egypt Cairo university
Role Name Email Phone Street address
Scientific Enquiries Mohammed Awad m_oj_h@yahoo.com +201005034393 9 said zulfakar st
City Postal code Country Position/Affiliation
cairo 12613 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