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.: PACTR202206898636627 Date of Approval: 23/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARATIVE STUDY OF CLINICAL OUTCOMES AFTER DAY-3 CLEAVAGE STAGE AND DAY-5 BLASTOCYST STAGE EMBRYO TRANSFER IN IN-VITRO FERTILIZATION AT THE FERTILITY UNIT OF FEDERAL MEDICAL CENTRE, ABUJA.
Official scientific title COMPARATIVE STUDY OF OUTCOME AFTER DAY-3 CLEAVAGE STAGE AND DAY-5 BLASTOCYST STAGE EMBRYO TRANSFER IN IN-VITRO FERTILIZATION AT THE FERTILITY UNIT OF FEDERAL MEDICAL CENTRE, ABUJA.
Brief summary describing the background and objectives of the trial It will be a prospective randomized study. One hundred and four consecutive eligible and consenting couples on whom a decision has been made for IVF treatment during the study period will be recruited for this study. Routine controlled ovarian stimulation, oocyte retrieval, and insemination shall be carried out on all participants. After this, embryo culture shall be conducted for either 3 days (cleavage embryo) or 5 days (blastocyst embryo) before subsequent transfer into the uterine cavity. Luteal phase support shall be with the use of progesterone vaginal pessaries followed by pregnancy test on the 14th day following embryo transfer. Data shall be collected with the use of well structure proformas and thereafter analysed using Statistical Software for Social Sciences (SPSS) Version 26.0. P value of <0.05 shall be considered significant. OBJECTIVES 1. To determine the biochemical pregnancy rates following cleavage stage embryo transfer versus blastocyst stage transfer in women undergoing In vitro fertilization at the Federal Medical Centre Abuja. 2. To compare the clinical pregnancy rates following cleavage stage embryo transfer versus blastocyst stage transfer in women undergoing In vitro fertilization at the Federal Medical Centre Abuja. 3. To determine the implantation rates following cleavage stage embryo transfer versus blastocyst stage transfer in women undergoing In vitro fertilization at the Federal Medical Centre Abuja. 4. To determine ongoing pregnancy rates following cleavage stage embryo transfer versus blastocyst stage transfer in women undergoing In vitro fertilization at the Federal Medical Centre Abuja.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NONE
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: Other
Anticipated trial start date 24/06/2022
Actual trial start date 12/10/2022
Anticipated date of last follow up 31/01/2023
Actual Last follow-up date 19/03/2023
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants) 104
Recruitment status Completed
Publication URL WEST AFRICAN COLLEGE OF SURGEONS
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group DAY 3 cleavage stage embryo transfer day-3 cleavage stage embryo transfer within 4 weeks each of the 52 participant in this group will have 2 cleavage-stage embryos transfered with luteal phase support using exogenous progesterone. 2 weeks post embryo transfer they all will a blood BHCG test to confirm pregnancy. 52 Active-Treatment of Control Group
Experimental Group DAY5 BLASTOCYST STAGE EMBRYO TRANSFER DAY5 EMBRYO TRANSFER WITHIN 4 WEEKS EACH OF THE 52 PARTICIPANT IN THIS GROUP WILL HAVE 2 DAY-5 BLASTOCYST STAGE EMBRYO TANSFERED, WITH LUTEAL PHASE SUPPORT FOLLOWED BY A BHCG TEST WITHIN 2 WEEKS OF EMBRYO TRANSFER. 52
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age must be between 18-39 years. 2. Normal baseline hormonal profile (FSH, LH, E2, Prolactin, and AMH). 3. Normal uterine cavity confirmed by hysterosalpingogram or hysteroscopy. 1. Maternal age above 39years 2. Women who did not fulfill inclusion criteria. 3. Women who had endocrine or metabolic disorder. 4. Women who had a history of chemotherapy or Radiotherapy 5. Women with uterine anomalies, or focal endometrial lesions (fibroid, polyp, adhesion, endometritis etc). 6. Patients with more than 3 unsuccessful IVF attempts 7. Patients with any contraindication for pregnancy 8. Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests Adult: 19 Year-44 Year 18 Year(s) 39 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 25/05/2022 HEALTH RESEARCH ETHICS COMMITTEE FMC ABUJA
Ethics Committee Address
Street address City Postal code Country
FEDERAL MEDICAL CENTRE JABI ABUJA ABUJA 9000001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Positive pregnancy test conducted two weeks after embryo transfer 2. Pregnancy confirmation via ultrasound revealing intrauterine gestation at 2 weeks after positive pregnancy test (4 weeks following embryo transfer) 3. Ongoing pregnancy by 20 weeks gestation. SECONDARY OUTCOMES1. Fertilization rates 2. Cleavage rates 3. Blastulation rates 4. Multiple pregnancy rates 5. Early pregnancy losses including: ectopic pregnancy and miscarriages occurring before 20 weeks pregnancy test after 2 weeks of ET, ULTRASOUND 4 WEEKS AFTER ET, ONGOING PREGNANCY BY 20 WEEK OF ET.
Secondary Outcome 2 SECONDARY OUTCOMES 1. Fertilization rates 2. Cleavage rates 3. Blastulation rates 4. Multiple pregnancy rates 5. Early pregnancy losses including: ectopic pregnancy and miscarriages occurring before 20 weeks cleavage rate day 2-3, blastulation rates day 4-5, multiple pregnancy 4weeks after ET,
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FERTILITY UNIT FEDERAL MEDICAL CENTRE JABI ABUJA PMB 7011 GARKI ABUJA FCT ABUJA 900001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
PRINCIPAL INVESTIGATOR FEDERAL MEDICAL CENTRE JABI ABUJA ABUJA 9000001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR. MICHAEL JOHN OFEM FEDERAL MEDICAL CENTRE JABI ABUJA ABUJA 9000001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
DR BENEDICT EKERETTE EKAIDEM FEDERAL MEDICAL CENTRE JABI ABUJA ABUJA 9000001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator JOHN OFEM MICHAEL debeloved79@gmail.com 2348030546055 federal medical centre jabi abuja
City Postal code Country Position/Affiliation
abuja 9000001 Nigeria principal investigator
Role Name Email Phone Street address
Scientific Enquiries BENEDICT EKERRRETE EKAIDEM drbenekaidem@yahoo.com +2348038803534 fedreral medical centre jabi abuja
City Postal code Country Position/Affiliation
abuja 9000001 Nigeria supervisor
Role Name Email Phone Street address
Public Enquiries peter jegede hrec.fmcabj@gmail.com +2348037779155 federal medical centre jabi abuja
City Postal code Country Position/Affiliation
abuja 9000001 Nigeria health research committee secretary
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the results that will and participants data obtained from this study that compared the clinical outcome between day-3 and day-5 embryo transfer at the fertility unit of federal medical centre abuja, will be made available to other researchers involved in similar work at other centres or institutions through the west african college of surgeon journal. Informed Consent Form april 2024 west african college of surgeons
URL Results Available Results Summary Result Posting Date First Journal Publication Date
west afrcan college of surgeons 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