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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206710346382 Date of Registration: 15/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Transferring blastocyst in FET cycle; does the stage at freezing make a difference ?
Official scientific title Comparative study on the vitrified compact morula and blastocyst of human embryos during in vitro fertilization (IVF)
Brief summary describing the background and objectives of the trial to assess difference between embryo cryopreservation at morula versus blastocyst with further thawing and transfer at blastocyst in frozen ICSI cycles
Type of trial Non-Randomised
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 Diagnosis / Prognosis
Anticipated trial start date 01/07/2022
Actual trial start date 01/08/2023
Anticipated date of last follow up 01/08/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status 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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Blastocyst Cryopreservation freezing D5 thawing and transfer at same day Cryopreservation of surplus embryos at D5(blastocyst) then thawing and transfer at same day 150 Active-Treatment of Control Group
Experimental Group Morula cryopreservation all surplus embryos will be cryopreserved at day 4 after thawing embryos were cultivated to D5 Cryopreservation of surplus embryos at D4(morula) then thawing and transfer 1 day later (Blastocyst) 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- age 40 years or less - patient with recurrent implantation failure - Uterine anomaly or poor endometrium - severe male factor - poor responders as defined by Bologna criteria Adult: 18 Year(s)-44 Year(s) 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 12/08/2023 Ethics committee of Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champlion st., El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Embryo survival rate 24 hours after thawing
Secondary Outcome - Clinical pregnancy rate 4 weeks after embryo transfer
Secondary Outcome Implantation rate 4 weeks after embryo transfer
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dar El Teb Ahmed Shawky street Alexandria Egypt
Dar El khousouba Fawzy Moaz Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ola Youssef Ahmed El-Shatby maternity university hospital, El-Geish road Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Egyptian foundation of reproductive endocrinology Smouha Alexandria Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Hassan Ali Maghraby Smouha Alexandria Egypt
Emad ElDin Khalifa 1st Fawzy Moaz street Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ola Youssef olayoussef_n@hotmail.com +201006041870 El-Shatby maternity university hospital, El-Geish road
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of obstetrics and gynaecology Alexandria University
Role Name Email Phone Street address
Public Enquiries Ola Youssef olayoussef_n@hotmail.com +201006041870 El-Shatby maternity university hospital, El-Geish road
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of obstetrics gynaecology Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Ola Youssef olayoussef_n@hotmail.com +201006041870 El-Shatby maternity university hospital, El-Geish road
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of obstetrics gynaecology Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes sharing of de-identified individual trial participant data. study protocol could be shared , it will be available for 24 months after publication. It will be shared whenever requested for purpose of meta-analysis Study Protocol 3 months after publication up to 24 months controlled, For individual participant metaanalysis
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