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.: PACTR202209544173620 Date of Approval: 01/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title GnRH agonist trigger VS HCG trigger for final oocyte maturation in GnRH antagonist protocol ICSI cycles
Official scientific title GnRH agonist trigger VS HCG trigger for final oocyte maturation in GnRH antagonist protocol ICSI cycles: A Randomized Controlled Study
Brief summary describing the background and objectives of the trial The aim of this study was to compare the effectiveness of GnRH agonist trigger versus HCG trigger to reduce OHHS and also on oocyte maturation, fertilization, embryo quality and clinical pregnancy rate.
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 Prevention
Anticipated trial start date 01/10/2019
Actual trial start date 31/10/2019
Anticipated date of last follow up 02/08/2020
Actual Last follow-up date 30/09/2020
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants) 200
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 Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group drug Choriomon 10000 IU intramuscular or Ovitrelle (Recombinant HCG) 250 IU subcutaneous. once Ovarian stimulation was done using fixed GnRH antagonis tprotocol. (on the 6th day of ovarian stimulation GnRH antagonist in the form of Cetrotide 0.25 mg was introduced till the end of stimulation) Stimulation started on day 2 or 3 of cycle using: Standard 150 IU of highly purified FSH(Fostimon) for patients below 37 years old.  75 IU FSH was added to the starting dose in case of: Age > 37 years old.  BMI mre than or equal ; 30 kg/m2 (PCO excluded).  Starting dose for PCO patients was 112.5 IU.  Adjustment of the doses was done according to the folliculometry results.1st U/S was done on day 6 on FSH stimulation. Then every other day until at least 3 of the follicles reach a volume of 18-24 ml then the trigger was given.as mentioned before then usual ICSI steps 100 Active-Treatment of Control Group
Experimental Group drug Decapeptyl 0.2 mg Subcutaneous. once the same steps as control group only different is trigger and no embryo transfer at same cycle ,Embryo freezing For GnRH agonist trigger group and HCG with OHSS. Cryopreservation was done in day 5 at the blastocyst stage.Only good quality embryos (Grade A and B blastocysts)were cryopreserved using a slow freeze technique in freezing media. Blastocysts were loaded in groups of 1-4 inside a straw andfrozen in a programmable freezer. Endometrial preparation for Frozen embryo transfer FET) was done by using Estradiol 2 started on day 2 or 3 of cycle with oral dose 6 mg divided on 3 doses in addition to Aspocid 75mg once daily with folic acid 500 mcg once dailyU/S on day 9 or 10 of cycle was done to assess endometrial thickness, then every other day until endometrial thickness of 8 mm or more was reached. When endometrial thickness reached 8 mm or more FET was planned. Progesterone was start 5 days before the planned FET day.. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Female age between 18 and 40 years. o Primary or secondary infertility. o Baseline FSH and LH lower than 12 IU/l. o Body mass index (BMI) between 18 and 40kg/m2. o Ovarian endometriosis. o Ovarian cysts before induction. o Known endocrinal abnormalities (like hypo or hyperthyroidism, hyperprolactinemia, pituitaryabnormalities). o AMH ≥ 10 ng/ml. o Duration of induction 6 days or less. or Duration of induction more than 16 days. o E2 drop during induction. o Last E2 level before trigger more than 10000pg/ml. o Immature oocytes syndrome. Adult: 19 Year-44 Year 18 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 02/10/2019 Ain Shams University faculty of medicine research ethical committee
Ethics Committee Address
Street address City Postal code Country
38 Abassyia Square Next To El Nour Mosque Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ovarian hyperstimulation syndrome OHSS rate For GnRH group assessment was done 7 days after OPU. For HCG group assessment was done on the day of planned ET.
Secondary Outcome 1-Oocyte maturation rate Percentage of Mature oocytes (MII) retrieved. 2-Fertilization rate Fertilization rate (FR) is percentage of transformation of micro injected oocytes into two pronuclei 3-Blastulation rate Blastulation rate is defined as the total number of blastocysts in a cycle (including those transferred and cryopreserved) divided by the total number of fertilized oocytes (Jones et al., 2020). 4-Biochemical pregnancy rate Biochemical pregnancy is a pregnancy diagnosed only by the detection of beta hCG in serum or urine 5-Clinical pregnancy rate Clinical pregnancy rate is the number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles. When clinical pregnancy rates are recorded, the denominator (initiated, aspirated orembryo transfer cycles) must be specified 6-Miscarriage rate Miscarriage is generally defined as a nonviable intrauterine pregnancy up to 20 weeks gestation B-HCG was done 15 days after ET. .
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Adam international hospital Aden street Mohandesen Cairo 12411Giza Egypt
Ain Shams University 38 elabassia Next to El NOUR mosque cairo none Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain shams University Elabassia cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Maternity Hospital and Adam International Hospital 38 Abbasiya Street Near El Nour Mosque CAIRO 11591 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Adam International HOSPITAL 20 Aden Street Mhandesen CAIRO 12411Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Snosi drmarwasnosi@gmail.com 0021200522228 Hadaque El Qubba
City Postal code Country Position/Affiliation
CAIRO 11646 Egypt Lecturer Obestatrics and Gynecology Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Marwa Snosi drmarwasnosi@gmail.com +021200522228 Hadeq El Qubba
City Postal code Country Position/Affiliation
Cairo 11646 Egypt lecturer obestatrics and gynecology Ain Shams University
Role Name Email Phone Street address
Public Enquiries Marwa Snosi drmarwasnosi@gmail.com +021200522228 hadeq el qubba
City Postal code Country Position/Affiliation
cairo no Egypt Lecturer of obstetrics and gynecology Ain Shams University
Role Name Email Phone Street address
Principal Investigator Mounir AlamelDin drmounir5m@gmail.com +21067574833 giza
City Postal code Country Position/Affiliation
cairo Egypt resident of obestatrics and gynecology manshet el bakry hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes cannot be shared due to privacy issues Study Protocol cannot be shared due to privacy issues available upon request due toprivacy issues
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/08/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/08/2022 Result - 28/08/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information