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.: PACTR201506001132105 Date of Approval: 07/05/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparing gonadotrophin releasing hormone agonist versus human chorionic gonadotrophin in improving IVF outcome
Official scientific title GnRH agonist versus human chorionic gonadotropin for triggering ovulation in antagonist cycles: randomized controlled trial
Brief summary describing the background and objectives of the trial Ovarian hyperstimulation syndrome (OHSS) is a serious complication of controlled ovarian stimulation (COS), affecting 1- 14% of all IVF cycles. Agonist triggering for final oocyte maturation in GnRH antagonist cycles provides promising results in the prevention of OHSS. As there are differences in the luteal phase hormonal milieu between cycles triggered by agonist and that triggered by hCG, the usual luteal phase support gave disappointing results in the reproductive outcome in the earlier studies. To improve the reproductive outcome in cycles triggered by agonist, modifications in the luteal phase support were introduced. This study aims to compare the outcome of cycles triggered by agonist to that triggered by hCG in the antagonist protocol.
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 compare the outcome of cycles triggered by agonist to that triggered by hCG in the antagonist protocol.
Anticipated trial start date 01/06/2015
Actual trial start date
Anticipated date of last follow up 31/05/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 190
Actual target sample size (number of participants) 190
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 randomization with fixed block size of 4 Sealed opaque envelops Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization with fixed block size of 4 Sealed opaque envelops Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group GnRH agonist "triptorelin" 0.3 mg Once 0.3 mg triptorelin will be given for final oocyte maturation and a bolus dose of 1500 IU hCG on the day of retrieval (35 hours after the agonist triggering). For luteal support, daily IM progesterone 100 mg and oral estradiol valerate 6mg will be started on the day of retrieval. 95
Control Group human chorionic gonadotropin 5000 IU Once 5000 IU hCG will be given for final oocyte maturation and for luteal support vaginal progesterone from the day of retrieval and estradiol valerate 6 mg orally from the day of embryo transfer. 95
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18 - 35 years old age. High responder PCO patients defined as having 18 follicles or more on the day of final oocyte maturation, measuring 11 mm or more in mean diameter and or estradiol level 4000 pg/ml or more. - women with uterine anomalies. - Women with uterine fibroids. - Women diagnosed with endometriosis. - Male factor of infertility requiring testicular biopsy. 18 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 03/05/2015 El Banoun Center for Infertility and IVF
Ethics Committee Address
Street address City Postal code Country
7 El Qawmeya St., Zagazig Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ongoing pregnancy rate at the end of 20 weeks of gestation
Secondary Outcome Clinical pregnancy rate At 7 weeks after embryo transfer
Secondary Outcome Miscarriage rate between 7 weeks to 20 weeks of gestation
Secondary Outcome OHSS Day of hCG to 7 weeks gestation
Secondary Outcome Number of retrieved oocytes At the day of oocyte retrieval (35 hours after triggering)
Secondary Outcome Number of MII oocytes At the day of oocyte retrieval (35 hours after triggering)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Banoun center for infertility and IVF 7 El Qawmeya st. El Zagazig N/A Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No external funding source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Magdy Ibrahim Mostafa Kasr El Ainy School of Medicine Cairo 11562 Egypt Hospital
Secondary Sponsor Eman Amin El Gindy 7 El Qawmeya St., Zagazig Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hoda Sibai 7 El Qawmeya St., Zagazig Egypt
Ahmed Gibreel Obstetrics and Gynecology department, Mansoura University Mansoura, Dakahlia Egypt
Emad Darwish Obstetrics and Gynecology department, Alexandria University Alexandria Egypt
Hasan Maghraby Obstetrics and Gynecology department, Alexandria University Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman El Gindy eman_elgindy2013@hotmail.com (20) 122 749 11 43 7 El Qawmeya St.,
City Postal code Country Position/Affiliation
Zagazig Egypt Prof. Ob/Gyn, Faculty of Medicine, Zagazig University
Role Name Email Phone Street address
Public Enquiries Magdy Mostafa imagdy@kasralainy.edu.eg (20) 100 520 730 5 Kasr El Ainy School of Medicine
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Prof. Ob/Gyn, Faculty of Medicine, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Magdy Mostafa imagdy@kasralainy.edu.eg (20) 100 520 730 5 Kasr El Ainy School of Medicine
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Prof. Ob/Gyn, Faculty of Medicine, Cairo University
REPORTING
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