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.: PACTR202010482774275 Date of Approval: 02/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Granulocyte Colony Stimulating Factor versus Human Chorionic Gonadotropin for recurrent implantation failure in Intra Cytoplasmic sperm injection.
Official scientific title Comparative study between Granulocyte Colony Stimulating Factor and Human Chorionic Gonadotropin in patients with history of recurrent implantation failure in Intra Cytoplasmic sperm injection.
Brief summary describing the background and objectives of the trial This study aims to compare the efficacy of Granulocyte Colony Stimulating Factor versus Human Chorionic Gonadotropin in reducing recurrent implantation failure n Intra Cytoplasmic sperm injection. One hundred had been randomized in two groups each group contained 50 patients. The primary outcome is clinical pregnancy. The secondary outcome is visualizing intra uterine gestational sac by ultrasound.
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 10/10/2020
Actual trial start date 10/10/2020
Anticipated date of last follow up 20/12/2020
Actual Last follow-up date 20/12/2020
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intrauterine Granulocyte Colony Stimulating Factor On embryo transfer day 50 patients will take intrauterine Granulocyte Colony Stimulating Factor (GCSF) on embryo transfer day 50
Control Group Human Chorionic Gonadotropin 500 units At embryo transfer 50 patients will take HCG 500 intrauterine on embryo transfer day 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with history of recurrent implantation failure All associated medical disorders should be excluded as diabetes, hypertension, heart diseases and thyroid disorders. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 50 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 08/10/2017 Quality Education Assurance Unit al Azhar Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Nasr City, Cairo Cairo 11651 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical pregnancy on Embryo transfer day
Secondary Outcome Visualizing intra uterine gestational sac by ultrasound On embryo transfer day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmed Oraby Fertility Center 3 El Nail Al Abyad, Ahmed Oraby st, Mohandeseen, Giza Giza Egypt
Wald we bent fertility center Madinet Nasr- Cairo Cairo Egypt
Dar Eltib fertility center 5 Aman, Ad Doqi, Dokki, Giza Giza Egypt
Alazhar university hospitals of damietta Kafr Elsad, New Damietta Damietta 34517 Egypt
Alazhar university hospitals of Assiut Al Walideyah Al Bahreyah, Asyut Second, Assiut Governorate Assiut 71515 Egypt
Alazhar university hospitals of Cairo Nasr city Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Elsayed Eldesouky Alagoza giza.3 nile abiad street Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wald we bent center Nasr city Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Elsayed Eldesouky elsayedeldesouky@yahoo.com 00201092934978 Alagoza giza.3 nile abiad street
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo
Role Name Email Phone Street address
Principal Investigator ElSayed Eldesouky elsayedeldesouky@yahoo.com 00201092934978 Alagoza giza.3 nile abiad street
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo
Role Name Email Phone Street address
Public Enquiries Mohamed Abd ElGawad mohammed.mahmod87@gmail.com +201069401202 El toba street
City Postal code Country Position/Affiliation
Fayoum Egypt Medical student at faculty of medicine Fayoum university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol Beginning 9 months and ending 36 months following article publication Researches who provide a methodologically sound proposal
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