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.: PACTR201704002212265 Date of Approval: 15/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Gonadotropin releasing hormone agonist flare-up versus gonatotropin releasing hormone antagonist protocols in poor responders undergoing ICSI:RCT
Official scientific title Gonadotropin releasing hormone agonist flare-up versus gonatotropin releasing hormone antagonist protocols in poor responders undergoing ICSI: a randomized controlled trial
Brief summary describing the background and objectives of the trial Purpose: To compare between the effect of GnRH flare-up and GnRH antagonist protocols in poor responders preparing for IVF on cycle parameters and clinical outcome. Patients and methods: One hundred and six qualified poor responders performing IVF will be randomly divided into 2 groups each containing 53 patients. Group 1 will receive GnRH flare-up protocol and group 2 will receive GnRH antagonist protocol. Data will be collected from both groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infertility Assisted reproduction
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/04/2017
Actual trial start date 15/04/2017
Anticipated date of last follow up 15/07/2017
Actual Last follow-up date 15/07/2017
Anticipated target sample size (number of participants) 106
Actual target sample size (number of participants) 106
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 randomisation 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
Experimental Group Gonadotropin releasing hormone flare-up 10 IU subcutaneous Leuprolide acetate per day + Exogenous gonadotropin stimulation, and the Leuprolide acetatedose was reduced to 5 IU only if patients had delayed response to gonadotropins. Gonadotropin releasing hormone flare-up started from cycle day one until the day of hCG administration + Exogenous gonadotropin stimulation started from day 2 Active 53
Experimental Group Gonadotropin releasing hormone antagonist Gonadotropin releasing hormone antagonist 0.25 mg cetrorelix + exogenous gonadotropins Exogenous gonadotropins were started on day 2 of the cycle +0.25 mg cetrorelix were added when the lead follicle reached 14 mm. in diameter and continued until the day of hCG administration Active 53
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Regular menstrual cycle (21-35 days duration), - body mass index (BMI) less than 30 kg/m2 - poor ovarian response according to Bologna Criteria - systemic disease e.g. diabetes or endocrinal disease e.g. polycystic ovaries - uterine pathology e.g. submucous fibroid polyp or fibroid, and those male factor 18 Year(s) 45 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 19/03/2017 Airforce specialized hospital ethical committee
Ethics Committee Address
Street address City Postal code Country
90(Elteseen street) Cairo Not available Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of retrieved oocytes Day of oocyte retrieval
Secondary Outcome Fertilization rate In the laboratory
Secondary Outcome Metaphase II oocytes In the laboratory
Secondary Outcome Embryo quality In the laboratory
Secondary Outcome Number of transferred embryos At the day of embryo transfer
Secondary Outcome Pregnancy rate Two weeks after embryo transfer
Secondary Outcome Miscarriage rate By ultrasound assessment at the end of the first trimester of pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al-Azhar University Downtown Cairo Not available Egypt
Airforce specialized Hospital 90 (Elteseen street) Cairo Not available Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Airforce specialized hospital 90(Elteseen street) Cairo Not available Egypt
Al-Azhar University Downtown Cairo Not available Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Airforce specialized hospital 90(Elteseen street) Cairo Not available Egypt Hospital
Primary Sponsor Airforce specialized hospital 90(Elteseen street) Cairo Not available Egypt Hospital
Primary Sponsor Al-Azhar University Downtown Cairo Not available Egypt University
COLLABORATORS
Name Street address City Postal code Country
Haitham Torky Central axis 6th October city Not available Egypt
Asem Anwar Moussa 123 Moustafa ElNahass-Medinat Nasr Cairo Not available Egypt
Ali Maher Ahmad Medinat Nasr Cairo Not available Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October city Not available Egypt October 6th University
Role Name Email Phone Street address
Public Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October city Not available Egypt October 6th University
Role Name Email Phone Street address
Scientific Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October city Not available Egypt October 6th 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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information