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.: PACTR202006915851110 Date of Approval: 30/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of granulocyte colony stimulating factor or human chorionic gonadotropin in improving embryo implantation
Official scientific title Effect of intra uterine human chorionic gonadotropin versus granulocyte colony stimulating factor at ovum pick up Day in cases of recurrent implantation failure
Brief summary describing the background and objectives of the trial The present study aimed to compare intrauterine injection of granulocyte colony-stimulating factor (G-CSF), intrauterine injection of Human Chorionic Gonadotropins (HCG), and normal saline in patients suffering from recurrent implantation failure and undergoing intracytoplasmic sperm injection (ICSI). The primary outcome measure of the present study is the biochemical pregnancy rate and implantation. The secondary outcome measures included clinical pregnancy rate and miscarriage 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 Treatment: Drugs
Anticipated trial start date 01/01/2019
Actual trial start date 01/01/2019
Anticipated date of last follow up 31/01/2020
Actual Last follow-up date 31/01/2020
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
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 Human Chorionic Gonadotropins 5,000 IU of hCG once after oocyte retrieval and before transfer embryos at the fifth day of fertilization Intrauterine injection of HCG was prepared, diluting one vial containing 5,000 IU of hCG to 10 cc of normal saline, so each 1 cm contain 500 IU of hCG that was injected using a Wallace embryo replacement soft catheter 50
Experimental Group Granulocyte Colony Stimulated Factor 300mcg/1.0 once after oocyte retrieval and before transfer embryos at the fifth day of fertilization Granulocyte Colony Stimulated Factor, Geneleukin 300mcg/1.0 . was administrated 50
Control Group saline normal saline once after oocyte retrieval and before transfer embryos at the fifth day of fertilization normal saline instead of HCG or Granulocyte Colony Stimulated Factor 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women aged 20-43 years old undergoing ICSI cycles history of recurrent implantation failure at least 1 cycle in which she had day 5 embryo transfer Women with renal sickle cell disease history of malignancy history of poor quality embryos risk of Ovarian hyperstimulation syndrome (OHSS) Adult: 19 Year-44 Year 20 Year(s) 43 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 at Azhar faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Nasr city, Cairo, Egypt Cairo 11765 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome clinical pregnancy rate (defined as viable pregnancy when there is evidence of gestational sac, embryo and fetal heart activity at time of trans-vaginal ultrasound evaluation by the 8th week) after 14 days from positive pregnancy test
Primary Outcome implantation rate (defined as the number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of embryos transferred). 6 weeks of pregnancy
Secondary Outcome Biochemical pregnancy rate (defined as positive from quantative values of serum test of β-hCG according to the standard values used in the laboratory at second week) at 8th week
Secondary Outcome miscarriage rate (defined as the loss of pregnancy before 8th weeks‘ gestational age 8th weeks gestational age
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wald we bent fertility center Nasr city Cairo Egypt
Ahmed Orabi fertility center almohandseen Giza Egypt
Dar eltib fertility center Amman street Giza 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 +201092934978 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 +201092934978 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