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.: PACTR202001787868341 Date of Approval: 24/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title GnRH-agonist trigger versus HCG trigger in cases of controlled ovarian
Official scientific title gonadotropin releasing hormone GnRH-agonist trigger versus human chorionic gonadotropin HCG trigger in cases of controlled ovarian stimulation
Brief summary describing the background and objectives of the trial Controlled ovarian stimulation (COS) which combines GnRH antagonist co-treatment and GnRH-agonist (GnRHa) trigger has become a common tool aiming to eliminate severe early OHSS and to support the concept of an OHSS-free clinic. One of the suggested optional strategies aiming to improve outcome was the addition of low-dose (1500 IU) HCG bolus, administered, concomitant, 35 h or 5 days after the triggering bolus of GnRHa. All these regimens were demonstrated to rescue the luteal phase, resulting in improved reproductive outcome in patients at risk to develop severe OHSS, compared to GnRHa trigger alone, however, with the questionable ability to eliminate severe OHSS. As part of a standard/conventional COS regimen, final oocyte maturation and resumption of meiosis are usually triggered by one bolus of hCG (5000–10,000 units), that is administered as close as possible to the time of ovulation (i.e. 36 h before oocyte recovery [1]. In 1990, Gonen et al. [2] have demonstrated that ovulation may be also triggered by GnRHa, causing the release of both endogenous LH and FSH, mimicking the natural cycle surge and therefore considered to be more physiologic.
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
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2019
Actual trial start date 01/02/2019
Anticipated date of last follow up 01/01/2020
Actual Last follow-up date 01/01/2020
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 291
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 randomization using a randomization 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 gonadotronin releasing hormone trigger group GnRh agonist (triptorelin 0.2 IU s.c.) once the group will start controlled ovarian stimulation on day 2 of menstruation, using sequential protocol starting oral ovulation induction (letrozole 5 mg daily ) then FSH daily injections of 75-150 IU, and will be monitored with transvaginal US on day 6 to modify the dose according to the patient response. Upon reaching a follicular size of 18 mm, triggering of ovulation will be given, GnRh agonist (triptorelin 0.2 IU s.c.) followed by timed intercourse 123
Control Group human chorionic gonadotropin trigger HCG (10,000 IU im) once the group will start controlled ovarian stimulation on day 2 of menstruation, using sequential protocol starting oral ovulation induction (letrozole 5 mg daily ) then FSH daily injections of 75-150 IU, and will be monitored with transvaginal US on day 6 to modify the dose according to the patient response. Upon reaching a follicular size of 18 mm, triggering of ovulation will be given, using HCG (10,000 IU im) followed by timed intercourse. 168 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age between 20-40 years. 2. Regular ovulatory menstrual cycles. 3. Normal male factor 4. Normal hystrosalpengiogram 1. Previous uterine surgery. 2. Evidence of endometrial, uterine or pelvic pathology. 3. Medical disorders or regular intake of medications. 4. Poor ovarian reserve Adult: 19 Year-44 Year 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 17/06/2019 faculty of medicine alexandria university
Ethics Committee Address
Street address City Postal code Country
17 champlion street alexandria Alexandria 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pregnancy rate after 2 weeks
Secondary Outcome abortion rate after 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
el shatby hospital portsaid street alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
suzan el sharkawy wekala street damanhour 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine alexandria university 17 champlion street Alexandria 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
samia mohamed samir sanhour behera 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed el mahdy mahdy.moh@icloud.com 00201002375636 faculty of medicine street
City Postal code Country Position/Affiliation
alexandria Egypt assistant profesor
Role Name Email Phone Street address
Scientific Enquiries suzan elsharkawy samirsuzan6@gmail.com 00201090052715 wekALA STREET
City Postal code Country Position/Affiliation
DAMANHOUR Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries samia samir samiasamir122@yahoo.com 01063747014 sanhour
City Postal code Country Position/Affiliation
damanhour Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes names and telephone numbers Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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