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.: PACTR202008705259380 Date of Approval: 14/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title RANDOMIZED CONTROL TRIAL ON THE EFFECTIVENESS OF ECHO TIP VERSUS NON-ECHO TIP EMBRYO TRANFER CATHETER FOR IMPROVING PREGNANCY RATE IN IN-VITRO FERTILIZATION CYCLES IN ANAMBRA STATE, NIGERIA
Official scientific title RANDOMIZED CONTROL TRIAL ON THE EFFECTIVENESS OF ECHO TIP VERSUS NON-ECHO TIP EMBRYO TRANFER CATHETER FOR IMPROVING PREGNANCY RATE IN IN-VITRO FERTILIZATION CYCLES IN ANAMBRA STATE, NIGERIA
Brief summary describing the background and objectives of the trial It is a Prospective Open Label Randomized Controlled Trial on Comparison of Pregnancy Rates Using Echo-Tip and Non-Echo-Tip Embryo Transfer Catheters In In-Vitro Fertilization Cycles in Anambra State, Nigeria. The main objective of the trial is to determine both chemical and clinical pregnancy rates in women who had ET with echo-tip and non-echo-tip catheters, while secondary objectives are; 1. To determine the number of to and fro movement required to achieve ET in both groups. 2. To determine the time interval between loading of the embryos and completion of ET in both groups. 3. To assess the presence of blood at the catheter following ET in both groups 4. To assess the frequency of return of the embryo during ET in both groups
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LIFE TRIAL
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: Devices
Anticipated trial start date 16/08/2020
Actual trial start date 16/08/2020
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 170
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 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 Echogenic embryo transfer catheter group one embryo transfer catheter for each client about 7 months The echogenic embryo catheter will be used for embryo transfer for the experimental group while the non-echogenic embryo transfer catheter will be used for control group 85
Control Group Non echogenic embryo transfer catheter group one embryo transfer catheter for each client for about 7 months Non echogenic embryo transfer catheter will be used for embryo transfer under transabdominal ultrasound guidance. Outcome measures will then be assessed afterwards. 85 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women within reproductive ages of 20 - 40 years Those with with good uterine cavity from pre-IVF assessment by ultrasound, hysteroscopy or sono-hysterogram will be recruited. Those that are willing to participate in the study and sign an informed consent. Those that are not willing to participate in the study will be excluded. Also, those with previous history of difficult embryo transfer or cervical problem will be excluded . Those with fewer than 2 embryos for transfer will be excluded from the study. Adult: 19 Year-44 Year 20 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
No 28/07/2020 CHUKWUEMEKA ODUMEGWU OJUKWU UNIVERSITY TEACHING HOSPITAL ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
ENUGU-ONITSHA EXPRESS WAY, AWKA AWKA 420211 Nigeria
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 03/08/2020 Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Enugu-Onitsha expressway Awka 420110 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Implantation rate (IR), 2. Clinical pregnancy rate (CPR) 3. Ongoing pregnancy rate. The primary outcome will be measured 2 weeks and 6 weeks post embryo transfer
Secondary Outcome 1. Ease of transfer (catheter failure rate) and 2. Simultaneous occurrence of traumatic events (e.g. use of a vulselum, stylet, sounding, and/or dilatation). 3. Presence of blood on the tip of the catheter 4. Presence of mucus on the tip of the catheter 5. Presence of retained embryos on the tip of the catheter. 6. Presence of complications after(abdominal cramps and/or vaginal bleeding) after embryo transfer During the embryo transfer and immediately after the embryo transfer
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Life fertility Centre of Life International Hospital Agu Awka industrial layout aWKA Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof Joseph Ikechelu Life International Hospital, Awka Awka 420110 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Joseph Ikechebelu Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Teaching Hospital Nnewi 435101 Nigeria Individual
Primary Sponsor Boniface Okpala Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Teaching Hospital Nnewi, Nnewi 435101 Nigeria Individual
Primary Sponsor George Eleje Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Teaching Hospital Nnewi 435101 Nigeria Individual
Primary Sponsor Princeton Okam Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Teaching Hospital Nnewi 435101 Nigeria Individual
Primary Sponsor Louis Nwajiaku Life International Hospital Awka 420211 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Kester Nwaefule Life International hospital Awka Nigeria
Somadina I. Okwelogu Life international Hospital Awka Nigeria
Okam Prinston Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Teaching Hospital Nnewi Nigeria
Ngozi JoeIkechebelu Department of Community Medicine, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Awka Nigeria
Chekwube Okwuoma Life International Hospital Awka Nigeria
Louis A Nwajiaku Life International Hospital Awka Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Ikechebelu ji.ikechebelu@unizik.edu.ng +2340834044189 Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Teaching Hospital
City Postal code Country Position/Affiliation
Nnewi Nigeria Principal investigator
Role Name Email Phone Street address
Scientific Enquiries Boniface Okpala biastalee@gmail.com +2348033204866 Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Teaching Hospital
City Postal code Country Position/Affiliation
Nnewi Nigeria Scientific Enquiries
Role Name Email Phone Street address
Public Enquiries George Eleje georgel21@yahoo.com +2340868117444 Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Teaching Hospital
City Postal code Country Position/Affiliation
Nnewi Nigeria Public Enquiries
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 Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol six months following publication, No end date open
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