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Trial registered on ANZCTR


Registration number
ACTRN12622000459729p
Ethics application status
Not yet submitted
Date submitted
10/03/2022
Date registered
23/03/2022
Date last updated
23/03/2022
Date data sharing statement initially provided
23/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
I-PRP-FET Trial: Intrauterine Platelet-Rich-Plasma Infusion Prior to Frozen Embryo Transfer in Women Undergoing In Vitro Fertilisation (IVF)
Scientific title
Effect of Intrauterine Platelet-Rich-Plasma Infusion Prior to Frozen Embryo Transfer on the Chemical and Clinical Pregnancy Rate in Women Undergoing In Vitro Fertilisation (IVF): A Randomised Controlled Trial
Secondary ID [1] 306625 0
None
Universal Trial Number (UTN)
U1111-1275-5415
Trial acronym
I-PRP-FET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent embryo implantation failure 325545 0
Infertility 325658 0
Condition category
Condition code
Reproductive Health and Childbirth 322914 322914 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undergo a transabdominal ultrasound performed to measure endometrial thickness 2-3 days prior to the embryo transfer. This is a baseline measure for post-intervention assessment of changes in endometrial thickness. Participants randomized to Platelet rich plasma (PRP) infusion will undergo venepuncture 2-3 days prior to planned embryo transfer. The 10 ml whole blood sample taken will be prepared on site to yield autologous PRP. The sample will be centrifuged on a Scanfuge Maxi by Origio, first spin at 300g and second spin at 700g. An hour after the blood collection the participant will then have the PRP sample infused into the uterine cavity by a fertility specialist. This procedure will take approximately 10 minutes to complete and will be delivered only once, it will be assumed complete once the PRP injection is complete. There will not be a post procedure ultrasound.
Administering the PRP solution:
(1) The subject is placed in a lithotomy position
(2) A speculum is inserted into the vagina and the cervix visualized
(3) Any mucus or vaginal discharge is wiped from the cervix
(4) A Cook catheter is gently inserted along the cervical canal and just beyond the internal os
(5) A Cook catheter is then gently inserted into the uterine cavity and 0.5-1.0 mL of the PRP solution is slowly injected over about 15-30 seconds using minimal pressure.
(6) The catheters and speculum are then removed.
Intervention code [1] 323065 0
Treatment: Other
Comparator / control treatment
Women in the control group will undergo the ultrasound to measure endometrial thickness but will not have a blood test, speculum examination or insertion of a catheter into the cervical canal.
Control group
Active

Outcomes
Primary outcome [1] 330718 0
Chemical pregnancy – defined as a serum beta human chorionic gonadotrophin level >25 IU/L at 11 days post-transfer
Timepoint [1] 330718 0
11 days post embryo transfer
Primary outcome [2] 330719 0
Clinical pregnancy – defined as the presence of a gestational sac on transvaginal ultrasound (USS) at 7 weeks gestation
Timepoint [2] 330719 0
5 weeks following embryo transfer
Secondary outcome [1] 407301 0
Live birth, defined as the birth of a live born neonate >20 weeks gestational age. This will be assessed via outcome data routinely collected by the IVF clinic for all patients available on their electronic record.
Timepoint [1] 407301 0
Delivery of pregnancy (within 40 weeks of embryo transfer)
Secondary outcome [2] 407302 0
The concentration of platelets in the autologous samples prepared for injection
Timepoint [2] 407302 0
Time of Platelet rich plasma preparation
Secondary outcome [3] 407303 0
The change in endometrial thickness on transabdominal ultrasound from 2 days prior to transfer to time of embryo transfer.
Timepoint [3] 407303 0
From 2 days prior to transfer to time of embryo transfer.

Eligibility
Key inclusion criteria
i. Women <40yo planned to undergo embryo transfer without pre-implantation genetic testing (PGT) who have had 1 or more consecutive previously failed embryo transfers (negative pregnancy test)
ii. Women of any age planning to undergo embryo transfer with PGT performed who have had 1 or more consecutive previously failed embryo transfers (negative pregnancy test)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Inability to provide informed consent
ii. Use of donor oocyte, sperm or embryo
iii. Congenital or acquired uterine malformation eg, Mullerian abnormality, Ashermann’s (this does not include subseptate or arcuate uterus)
iv. Previously had embryo transfer as part of this study
v. Multiple embryos transferred

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque sequentially numbered envelopes will be used. The envelopes will be prepared by the research team and contain the assigned study intervention (PRP vs control), this will be opened following enrolment into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sized block randomization scheme will be used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is powered to demonstrate superiority. The overall rates of chemical pregnancy, clinical pregnancy and live births for Newlife IVF are 42.5%, 34% and 25.5% respectively (for patients fitting the entry criteria). In Maleki-Hajiagha’s meta-analysis, the relative risk(RR) for clinical pregnancy for women with recurrent implantation failure was 1.79. Given the population in the current study is not limited to those with implantation failure, it is predicted that the potential gain would be lower, so RR of 1.50 was chosen as a clinically relevant change that would lead to altered practice.
For a baseline chemical pregnancy rate of 42.5% this would produce an expected rate in the treatment group of 63.8%. With power of 0.80 and alpha=0.05, the calculated sample size is N=170 (N=85 per arm).
For a baseline clinical pregnancy rate of 34% this would produce an expected rate in the treatment group of 51%. With power of 0.80 and alpha=0.05, the calculated sample size is N=264 (N=132 per arm). We will use this latter sample size for the study.
The outcomes of chemical pregnancy, clinical pregnancy and live birth are binary outcomes, so will be presented as proportions (or percentages). Continuous outcomes of endometrial thickness and platelet concentration will be presented as means (standard deviation). The same methods will be used to present categorical and continuous demographic measures.
Comparisons of proportions will involve estimation of odds ratios using logistic regression, with associated 95% confidence intervals. Continuous variable comparisons will be made using repeated measures ANOVA.
Using the same techniques, exploratory sub-group analyses will be performed for transfers with and without PGT testing.
Logistic regression modelling will be performed to explore the effect of platelet concentration in the PRP, and pre-injection and pre-transfer endometrial thickness on pregnancy outcomes. Potential confounders of subject age, PGT status and frozen embryo transfer (FET) protocol will be adjusted for if found to have a significant association with the outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
264
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310957 0
Other
Name [1] 310957 0
NewLife IVF Clinic
Country [1] 310957 0
Australia
Primary sponsor type
Individual
Name
Martin Healey
Address
NewLife IVF Clinic
Suite 3, Ground Floor/ 116-118 Thames Street
Box Hill North
VIC 3129
Country
Australia
Secondary sponsor category [1] 312286 0
None
Name [1] 312286 0
Address [1] 312286 0
Country [1] 312286 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 310516 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 310516 0
Ethics committee country [1] 310516 0
Australia
Date submitted for ethics approval [1] 310516 0
04/04/2022
Approval date [1] 310516 0
Ethics approval number [1] 310516 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117922 0
A/Prof Martin Healey
Address 117922 0
NewLife IVF Clinic
Suite 3, Ground Floor/116-118 Thames Street, Box Hill North, VIC 3129
Country 117922 0
Australia
Phone 117922 0
+61 0488334519
Fax 117922 0
Email 117922 0
martin1963healey@gmail.com
Contact person for public queries
Name 117923 0
Martin Healey
Address 117923 0
NewLife IVF Clinic
Suite 3, Ground Floor/116-118 Thames Street, Box Hill North, VIC 3129
Country 117923 0
Australia
Phone 117923 0
+61 0488334519
Fax 117923 0
Email 117923 0
martin1963healey@gmail.com
Contact person for scientific queries
Name 117924 0
Martin Healey
Address 117924 0
NewLife IVF Clinic
Suite 3, Ground Floor/116-118 Thames Street, Box Hill North, VIC 3129
Country 117924 0
Australia
Phone 117924 0
+61 0488334519
Fax 117924 0
Email 117924 0
martin1963healey@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.