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.: PACTR201802003072343 Date of Approval: 11/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Conventional GnRH Antagonist Protocol Versus Segmentation Protocol
Official scientific title Conventional GnRH Antagonist Protocol Versus Segmentation Protocol In Patients Undergoing Intracytoplasmic Sperm Injection (ICSI)
Brief summary describing the background and objectives of the trial GnRH antagonists have been introduced into the ovarian stimulation protocol to overcome some of these disadvantages, the results of all of the studies showed higher fertilization rates, mean numbers of good-quality embryos, and pregnancy rates, as well as a low incidence of OHSS, indicating the usefulness of GnRH antagonists in ovarian stimulation protocol. A segmentation concept in management of OHSS was reported, leading to an OHSS free clinic. It consists of optimization of the ovarian stimulation, including GnRHa triggering in a GnRH antagonist cycle (segment A). Segment B then consists of optimum cryopreservation methods for oocyte or embryo vitrification. Segment C includes embryo replacement in a receptive, non-stimulated endometrium in a natural cycle or with artificial endometrial preparation. Considering all the possible side effects of COS on endometrial receptivity, as discussed above, recent studies have shown better IVF outcomes when performing elective FET. Furthermore, using the freeze-all strategy, there is an advantage in that the entire cohort of embryos is cryopreserved¿not just the ¿second best¿, which is what occurs when the morphologically best embryos are transferred in a fresh cycle. The aim of the work is to compare the clinical outcomes of standard antagonist protocol versus segmentation protocol in patients undergoing IVF/ICSI as regards Clinical Pregnancy Rate (CPR), quality of embryos transferred and occurrence of Ovarian Hyperstimulation Syndrome (OHSS).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infertility,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2016
Actual trial start date 01/01/2017
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date 31/07/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Permuted block randomisation (variable block size) 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 Segmentation protocol Cetrolix 0.25 mg + a bolus of 0.2 mg triptorelin (Decapeptyl®) + 2mg estradiol valerate three times daily starting on day 3 of menses. from day 6 of the cycle. Treatment with GnRH antagonist will be continued daily thereafter until and including the day of GnRH agonist administration. Oocyte retrieval will be conducted after 34-36 hours of GnRHa administration + vitrifying all embryos + thawed embryo transfer in the next cycle + luteal phase support 30
Control Group Standard antagonist protocol cetrolix 0.25 mg + 10000 IU of hCG. from day 6 of the cycle. Treatment with GnRH antagonist will be continued daily thereafter until and including the day of hCG adminstration Oocyte retrieval will be conducted after 34-36 hours of hCG adminstration +fresh embryo transfers of day 3 embryos. +Luteal phase support 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The period of infertility is at least 1 year. All patients will be indicated for IVF or ICSI. - endometriosis. - Azoospermia. - Previous history of ovarian or pelvic surgery. - Congenital uterine abnormalities even if corrected. - Poor responders. 20 Year(s) 35 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 20/04/2017 IRB, The ethics committee of Faculty of Medicine, Alexandria University
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 Clinical Pregnancy Rate (CPR). noted by appearance of the gestational sac with fetal pole with cardiac activity in the uterus using trans-vaginal ultrasonography at about 6 weeks of gestation
Secondary Outcome Quality of embryos transferred. On the day of transfer
Secondary Outcome Occurrence of Ovarian Hyperstimulation syndrome (OHSS). After Adminstration of hCG or GnRH agonist
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology, Elshatby Maternity Hospital, Faculty of Medicine, University of Alexandria Port Said Street, ElShatby Alexandria 21526 Egypt
Integrated Fertilty center Alexandria New Medical center ¿ Smouha Alexandria 21615 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Alexandria Port Said Street, ElShatby Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Alexandria Port Said Street, ElShatby Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Emad Abd Elmoneim Darwish Elshatby Maternity Hospital, Port Said Street, ElShatby Alexandria 21526 Egypt
Tamer Hanafy Mahmoud Elshatby Maternity Hospital, Port Said Street, ElShatby Alexandria 21526 Egypt
Sherif Salah Gaafar Elshatby Maternity Hospital, Port Said Street, ElShatby Alexandria 21526 Egypt
Mohamed Nagy Zaher Balbaa Elshatby Maternity Hospital, Port Said Street, ElShatby Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emad Darwish edarwish@hotmail.com +2-01222164100 Port Said Street, ElShatby
City Postal code Country Position/Affiliation
Alexandria 21526 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
Role Name Email Phone Street address
Scientific Enquiries Sherif Gaafar shgaafar301@yahoo.com 002-01224107065 Port Said Street, ElShatby
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Lecturer of Obstetrics and Gynecology, Faculty of Medicine, University of Alexandria
REPORTING
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