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.: PACTR202206698504097 Date of Registration: 07/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SINGLE VERSUS DOUBLE AGONIST TRIGGER IN ANTAGONIST PROTOCOL CYCLES: A MULTICENTER RCT
Official scientific title SINGLE VERSUS DOUBLE AGONIST TRIGGER IN ANTAGONIST PROTOCOL CYCLES: A MULTICENTER RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Final oocyte maturation trigger is one of the most important key success factors in assisted reproductive technologies (ARTs). Until now, administering 5000 IU to 10,000 IU of hCG 34–36 h prior to oocyte retrieval remained the standard protocol for the induction of final oocyte maturation in IVF cycles worldwide. Traditionally, human chorionic gonadotropin (hCG) has been the trigger of choice for oocyte maturation due to its molecular and biological similarity with LH. Gonadotropin-releasing hormone (GnRH) agonists were first suggested for final oocyte maturation by Gonen et al. in 1990, as it is able to trigger endogenous release of both FSH and LH. GnRHa trigger is the cause of FSH surge that moves up nuclear maturation. GnRH agonist induces surge of both LH and FSH and has shorter activity that result in notable decrease in the risk of ovarian hyperstimulation syndrome (OHSS). However, some problems surfaced with the substitution of GnRH-agonists as trigger. The risk of empty follicle syndrome was reported to be increased following isolated GnRH-agonist trigger due to a suboptimal LH surge. Hence, a single dose of GnRHa might not be able to induce an LH surge above a threshold level and for a threshold duration (mimicking physiological surge) that is required for adequate oocyte maturation. The aim of this study is to establish if a second dose of GnRHa repeated 12 h following the initial dose optimizes the cycle outcome in terms of ongoing pregnancy rate in women undergoing intracytoplasmic sperm injection (ICSI) cycles using a GnRH‐antagonist protocol.
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,Fertility-male,Infertility
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/06/2022
Actual trial start date
Anticipated date of last follow up 14/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 randomization 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 Double Dose A dose of GnRH agonist triptorelin 0.3 mg and a second dose of 0.2 mg. first 36 hours prior to oocyte retrieval and second following the first dose 24 hours before oocyte retrieval Two doses of GnRH agonist triptorelin the first as in group A 0.3 mg ( 3 ampoules of Decapeptyl 0.1 mg; Ferring or Triptofem 0.1 mg; Marckyrl Pharma Gmbh) subcutaneously 36 h prior to oocyte retrieval + a second dose of 0.2 mg 12 h following the 1st dose ( 24 h before oocyte retrieval). 80
Control Group Single Dose 0.3 mg GnRH agonist triptorelin 36 hours prior to oocyte retrieval single dose of 0.3 mg GnRH agonist triptorelin ( 3 ampoules of Decapeptyl 0.1 mg; Ferring or Triptofem 0.1 mg; Marckyrl Pharma Gmbh) subcutaneously, 36 h prior to oocyte retrieval. 80 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women with a spontaneous normal menstrual cycle and a normal uterine cavity. Body mass index (BMI) < 35. Age less than 40. Average responders with AMH level above 1.2 ng/ml. All patients will be indicated for ICSI. Comorbidities including, hypertension, Diabetes Mellitus or other endocrinopathies. Surgically retrieved sperms. Communicating hydrosalpinx if not treated. Cases with uterine abnormalities even if corrected. Poor responders. Polycystic ovary syndrome patients. Adult: 19 Year-44 Year 20 Year(s) 39 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 17/03/2022 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ongoing pregnancy 14 days after embryo transfer till 20th weeks of gestation
Secondary Outcome Oocyte maturity rate. 24 hours post oocyte retrieval day
Secondary Outcome Number of oocytes retrieved After retrieval
Secondary Outcome Post-trigger serum luteinizing hormone (LH) 12 and 24 hours post trigger with the first injection of GnRHa
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Life Clinic 5 El-Shaheed Tayar Mahmoud Shakir, Mohammed Abd El-Moneim, Ezbet Saad, Sidi Gaber, Alexandria Governorate Alexandria 21523 Egypt
ElMadina fertility center Ezbet Saad, Sidi Gaber, Alexandria Governorate Alexandria 21648 Egypt
Agial fertility center 2 Alfred Layan st Roushdy Sidi Gabir Alexandria Governorate Alexandria 21529 Egypt
Dar elkhosoba fertility center 1 Fawzy moaz street, Sidi Gaber, Alexandria Alexandria 21648 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Nagy Zaher Balbaa 31 ahmed abd elaziz st. Sidi Gaber Alexandria 21529 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obstetrics and Gynaecology Faculty of Medicine Alexandria University Port Said Street Shatby Bab Shark Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Nagy Zaher Balbaa 31 ahmed abd elaziz st. Sidi Gaber Alexandria 21529 Egypt
Hassan Aly El Maghraby 5 El-Shaheed Tayar Mahmoud Shakir, Mohammed Abd El-Moneim, Ezbet Saad, Sidi Gaber, Alexandria Governorate Alexandria 21523 Egypt
Yasser Saad El Kassar Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi, Alexandria Governorate Alexandria 21524 Egypt
Mohamed El Mahdy Abd El Moneim 13 gliys, street, Alexandria Governorate Alexandria 21563 Egypt
Emad El din Khalifa 1 Fawzy moaz street, Sidi Gaber, Alexandria Alexandria 21648 Egypt
Ashraf Abo Ali Ezbet Saad, Sidi Gaber, Alexandria Governorate Alexandria 21648 Egypt
Hisham Aly Saleh 2 Alfred Layan st Roushdy, Sidi Gabir, Alexandria Governorate Alexandria 21529 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan El Maghraby hassanmaghraby@gmail.com 00201222137317 5 El-Shaheed Tayar Mahmoud Shakir, Mohammed Abd El-Moneim, Ezbet Saad, Sidi Gaber, Alexandria Governorate
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Professor of Obstetrics and Gynecology Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Yasser El Kassar Yasser_elkassar@Hotmail.com 00201117789003 Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi, Alexandria Governorate
City Postal code Country Position/Affiliation
Alexandria 21524 Egypt Professor of Obstetrics and Gynecology Faculty of Medicine University of Alexandria
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 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
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