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.: PACTR201602001448165 Date of Approval: 31/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title HCG prettreatment
Official scientific title effeect of HCG pretreatment on pregnancy outcome in POR :RCT
Brief summary describing the background and objectives of the trial we will try to give HCG from day 2 to day 5 as a cheap alternative to rLH for patient diagnosed as POR
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2016
Actual trial start date 01/01/2016
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
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 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 standard long protocol 300-450 U FSH up to 2 weeks standard long agonist 50 Active-Treatment of Control Group
Experimental Group HCG preatreatment 50 U HCG from Day 2-day5 2weeks HCG pretreat 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients fulfilling criteria of POR according to Bolgna criteria patient not fulfilling previous criteria 35 Year(s) 43 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 05/01/2016 CUH ethical committee
Ethics Committee Address
Street address City Postal code Country
Kasr alainy St cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome clinical pregnancy rate 6 weeks of pregnancy
Secondary Outcome implantation rate 6 weeks of pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ART of Cairo University Kasralainy st Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CUH kasralainy st cairo 11553 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CUH kasr alainy st Cairo 11553 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed H Awad 9 zulfakar st Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com +201111765934 24 Abdelrahman albarkoky-almanyal
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Awad m_oj_h@yahoo.com 00201005034393 9 zulfakar st
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Awad m_oj_h@yahoo.com 00201005034393 9 zulfakar st
City Postal code Country Position/Affiliation
Cairo 11553 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