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.: PACTR202207593734974 Date of Approval: 25/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A quick, easy and effective method of embryo transfer; pre-determined ultrasound measurements “PUM”
Official scientific title Comparative study between ultrasound guided embryo transfer and pre-determined ultrasound measurements of uterine length
Brief summary describing the background and objectives of the trial we will compare the use of transabdominal ultrasound guided embryo transfer and easier technique by pre-determined ultrasound measurements of uterine length
Type of trial CCT
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 technique of embryo transfer
Anticipated trial start date 01/08/2022
Actual trial start date
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
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 ultrasound guided embryo transfer once concomitant with embryo transfer transabdominal ultrasound (full bladder) is used concomitant with introduction of embryo transfer catheter 100 Placebo
Experimental Group predetermined ultrasound measurement once before embryo transfer immediate before embryo transfer, uterine length will be measured using transvaginal ultrasound, The length of the cervix from external to internal os (A–B) and the distance between the internal uterine os and fundal endometrium (B–D) are measured. subtract 1 from sum of 2 measurements (represents total uterine length from tip of endometrium to external os) and adjust catheter tip at this distance during transfer but without using transabdominal ultrasound at time of transfer.. After ET the distance of air bubble and tip of endometrium was measured 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
female age 37 years or less recurrent implantation failure poor resopnders (AMH < 1.1 ng/ml, less than 3 oocytes retrieved) Adult: 19 Year-44 Year 18 Year(s) 37 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
No 23/07/2022 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 clinical pregnancy rate 4 weeks after embryo transfer
Secondary Outcome time loading to transfer time from loading embryos at catheter till transfer of embryos
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dar El teb Ahmed Shawky 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
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 6 months after publication. It will be shared whenever requested for purpose of meta-analysis Study Protocol 3 months after publication up to 6 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