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.: PACTR202110880033371 Date of Approval: 28/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intrauterine Follicular Fluid Injection: A Potential Novel Approach to Improve the Endometrium
Official scientific title Intrauterine Follicular Fluid Injection: A Potential Novel Approach to Improve the Endometrium
Brief summary describing the background and objectives of the trial Implantation of human embryos is the least-understood step in assisted reproductive technology. Successful implantation requires a synchronized interaction between the endometrial secretory pattern and competent embryos in both natural and assisted reproduction cycles. Such cross-talk at the maternal-fetal interface is coordinated by local ovarian hormones, estrogen, progesterone, cytokines, chemokines, and growth factors. Endometrial thickness and pattern are independent factors that affect pregnancy outcomes, and thin endometrium was considered as an independent negative prognostic factor for achieving pregnancy in women, and the endometrial thickness even thin endometrium has a negative effect on neonatal outcome. The incidence rate of thin endometrium is about 2.4% in the assisted reproductive technology cycles, and is associated with lower implantation rate and pregnancy rate. The follicular fluid of mature oocytes is rich in growth factors (e.g. stem cell factor, vascular endothelial growth factor, transforming growth factor, and insulin-like growth factor) and cytokines that may exert paracrine and autocrine effects on implantation, as transforming growth factor controls apoptosis, vascular endothelial growth factor promotes angiogenesis, insulin-like growth factor improves endometrial growth, and the immunosuppressive activity of the follicular fluid paves the way for the embryo to implant in the uterine cavity. The immunosuppressive activity of follicular fluid is mediated by the specific inhibition of interleukin-1 alpha and interleukin-2 production, and decreased CD25 expression. The aim of the study is to evaluate the effect of intrauterine follicular fluid injection on endometrial thickness and implantation.
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,Fertility-male
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2021
Actual trial start date
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet 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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Follicular fluid 1 ml Once after oocyte pick up After oocyte pick up, follicular fluid will be centrifuged and 1 ml will injected in the uterine cavity using IUI catheter. 30
Control Group Standard N/A No follicular fluid injection 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primary infertility case indicated for ICSI BMI < 35kg/m2 Normal 3D Ultrasound for uterine cavity. Uncorrected uterine anomalies. Azoospermia. Poor ovarian reserve according to Bologna criteria. A patient who indicated for verification of all embryos and canceled fresh embryo transfer. 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
Yes 15/04/2021 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Endometrial Thickness Day of HCG Day of oocyte retrieval Day of embryo transfer.
Primary Outcome Endometrial compaction will be calculated as the difference in the endometrial thickness between the day of HCG and the day of embryo transfer
Secondary Outcome Implantation fourteen days after embryo transfer
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ElShatby University Maternity Hospital Port Said Street El Shatby Bab Sharqi Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maha Ahmed Abd Ellatif Mohamed Andalous Building ElTayar Ahmed Soud Abou Aly Alexandria 21531 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obstetrics and Gynecology Faculty of Medicine University of Alexandria Egypt Port Said Street El Shatby Bab Sharqi Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hassan Ali Elmaghraby 5 Mahmoud Shokry street, Smouha Alexandria 21615 Egypt
Ashraf Hany Aly Abd Elrahman 53 Mohamed Elsayed Hefny, Celiopatra Alexandria 21618 Egypt
Sherif Salah Gaafar 162 Omar Lotfy Al Ibrahimeyah Alexandria 21531 Egypt
Maha Ahmed Abd Ellatif Mohamed Andalous Building ElTayar Ahmed Soud Abou Aly Alexandria 21531 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Elmaghraby hassanmaghraby@gmail.com 00201222137317 5 Mahmoud Shokry street, Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Professor of Obstetrics and Gynecology Faculty of Medicine University of Alexandria Egypt
Role Name Email Phone Street address
Scientific Enquiries Sherif Gaafar shgaafar301@yahoo.com 00201224107065 162 Omar Lotfy Al Ibrahimeyah
City Postal code Country Position/Affiliation
Alexandria 21617 Egypt Assistant Professor of Obstetrics and Gynecology Faculty of Medicine University of Alexandria Egypt
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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