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.: PACTR201411000933365 Date of Approval: 08/11/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Antagonist versus agonist protocols: in patients with polycystic ovary syndrome treated for ICSI cycles
Official scientific title Fixed gonadotrophin releasing hormone antagonist protocol versus gonadotrophin releasing hormone agonist : long protocol in patients with polycystic ovary syndrome treated for ICSI cycles.
Brief summary describing the background and objectives of the trial Cases divided into 2 groups 100 cases take agonist(Decapeptyl) 0.1mg 6 days before discontinuation of ocps .100 cases will take antagonist (Cetrotide). 0.25mg in cycle day5.Gonadotrophin taken when desensitization occur in agonist group , taken in day 3 in antagonist group.Both agonist and antagonist continued till the day of hCG.hCG taken when follicles reach adiameter of ¿ 18mm in agonist group and ¿ 17mm in antagonistbgroup.The aim is to compare between both protocols in PCOS patients undergoing ICSI and ICSI outcome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infertility in PCOS patients,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2014
Actual trial start date 01/06/2014
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Closed to recruitment,follow-up continuing
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 of 4 and the block size was not variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Agonist 0.1mg Decapeptyl 100
Experimental Group Antagonist 0.25 mg Cetrotide 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Normogonadotrophic females ( tubal factor ¿ unexplained infertility) 2.PCOS patients fulfilling roterdam criteria of PCOS). Diagnosis depends on two of the following criteria only: Clinical and/or biochemical evidence of hyperandrogenism with exclusion of other causes of androgen excess. Oligo or anovulation. Polycystic ovaries by ultrasound(ovarian volume>12cc with 10 or more cysts 2- 8mm in diameter arranged around echo 3.Body mass index(BMI)<35. critria:1.Hypogonadotrophic patients 2. Hypergonadotrophic patients. 3.BMI>35 4.Endometriosis 5.Poor response in previous ICSI cycles 6.uterine factor infertility. 7.Severe male factor infertility. 8.History of ovarian surgery. 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 01/06/2014 Ethics Committee, Faculty of Medicine, University of Alexandria
Ethics Committee Address
Street address City Postal code Country
Azarita Aelxandria Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total number of oocytes During the ICSI cycle
Primary Outcome The number of mature oocytes per cycle of induction During ICSI cycle
Primary Outcome Serum estradiol and progesterone level on the day of HcG. During ICSI cycle
Primary Outcome Implantation rate(number of sacs per number of embryo transfer). At day of Embryo transfer
Secondary Outcome Clinical pregnancy confirmed by observing fetal cardiac pulsation 2 weeks after positive pregnancy test by transvaginal ultrasound.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
EL Shatby Maternity University Hospital Port-Said Street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Obestetrics and Gynaecology Department, Faculty of Medicine, University of Alexandria Port-Said Street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obestetrics and Gynaecology Department, Faculty of Medicine, University of Alexandria Port-Said Street Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Emad Eldin Abd El-rahman Khalifa 23 Medan Sad Zaghlol-Mahtet Elraml(Dar elkhsoba) Alexandria Egypt
Yasser Ibrahim Orief Mahtet Taram Sedi Gaber Elshekh borg panorama elshark Alexandria Egypt
Tamer Hanafy Mahmoud Said 20 st Dr Elsabongy Emaret elbostan Saba basha Alexandria Egypt
Doaa AbdAllah Abd Elmaksoud Elawady hospital Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emad Eldin Khalifa emadkhalifa@yahoo.com 002-01002333413 23 Medan Sad Zaghlol-Mahtet Elraml(Dar elkhsoba)
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Professor of Obestritics and Gynaecology, Faculty of Medicine, University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Yasser orief info@yaserorief.net 00201008233121 Mahtet Taram Sedi Gaber Elshekh borg panorama elshark
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Obestritics and Gynaecology, Faculty of Medicine, University of Alexandria
REPORTING
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