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.: PACTR201307000566378 Date of Approval: 18/06/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Infertile women undergoing ICSI,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2013
Actual trial start date 01/08/2013
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 400
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 randomisation - block size 4; block size was not variable Sealed opaque envelopes Masking/blinding used Participants
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 Age Category Minimum age Maximum 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 Year(s) 37 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 07/06/2013 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 07/06/2013 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
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
Alexandria ICSI/IVF Center 4 Mogahedin street el Hedaya Alexandria 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 Street address
Principal Investigator Eman Elgindy eman_elgindy2013@hotmail.com 01227491143 Apart 22, building 13, group 76, Rehab City
City Postal code Country Position/Affiliation
Cairo 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 21516 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 #402 Egypt Professor of Obstetrics and Gynaecology
REPORTING
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Changes to trial information