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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.: PACTR201307000566378 Date registered: 2013/06/18
TRIAL DESCRIPTION
Public title The use of estrogen pretreatment before starting controlled ovarian stimulation in antagonist protocol.
Official scientific title Impact of estrogen pretreatment on the outcome of GnRH antagonist protocol: a prospective randomized multicenter trial
Brief summary describing the background
and objectives of the trial
Gonadotrophin stimulation is usually started on day 2 or 3 of the menstrual cycle when the follicular cohort has already started to grow under the effect of the rising inter cycle FSH. Luteal estradiol administration has been suggested to improve early follicular cohort synchronization as well as facilitate cycle programming. Therefore, the aim of this prospective multicenter randomized study is to assess the impact of estrogen pretreatment before antagonist cycles on ovarian stimulation.
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 2013-08-01
Actual trial start date 2013-08-01
Anticipated date of last follow up 2014-12-31
Actual date of last follow up 2014-12-31
Anticipated target sample size (number of participants) 400   
Actual target sample size (number of participants) 400   
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 4; block size was not variable Sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group No Estrogen 200 Uncontrolled
Experimental group Estrogen 4 mg E2 10 days 4 mg E2 daily from day 21 of pretreatment cycle for at least 10 days. When menses start, we continue with E2 till desired day of starting treatment ( at least 10 days of E2 have been used) then start HMG and discontinue E2. 200

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Regular cycles (26¿35days) Day 3 FSH <9.5 IU/L Basal antral follicle count >6. First or second ICSI attempt. History of low ovarian response in an earlier ICSI attempt. Recurrent implantation failure 18 Years 37 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
Yes 2013/06/07 Board of the EBWHS
Ethics Committee Address
Street address City Postal code Country
51 Shehab st; Mohandeseen Cairo Egypt
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 2013/06/07 Alexandria IVF/ICSI Center Ethical Committee
Ethics Committee Address
Street address City Postal code Country
4 ElMoghadeen Street, Elhedia Alexandria Egypt

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 Cycle cancellation At the end of stimulation protocol
Secondary Outcome Abortion any time

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria ICSI/IVF Center 4 Mogahedin street el Hedaya Alexandria Egypt
Misrata National Center for infertility treatment LISCO Company Village - Kasr Ahmed Misrata Libyan Arab Jamahiriya
Ganna IVF Hospital 51 Shehab st; Mohandeseen, Cairo 11451 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 Hassan Aly Hassan Elmeghraby 649 Horria Avenus, Janaklis Alexandria Egypt Hospital

COLLABORATORS
Name Street address City Postal code Country
Hassan Aly Hassan Elmeghraby 649 Horria Avenus, Janaklis Alexandria Egypt
Ismail M elfourteia LISCO Company Village Kasr Ahmed Misrata Libya Misrata Libyan Arab Jamahiriya
Eman Elgindy Apart 22, building 13, group 76, Rehab City Cairo Egypt

CONTACT PEOPLE
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 21516 Egypt Patient Information Manager
Role Name Email Phone Fax
Principal Investigator Prof Eman Elgindy eman_elgindy2013@ hotmail.com 01227491143 002 03 5855763
Street address City Postal code Country Position / Affiliation
Apart 22, building 13, group 76, Rehab City Cairo 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 #402 Egypt Professor of Obstetrics and Gynaecology