Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000390684
Ethics application status
Approved
Date submitted
13/03/2023
Date registered
18/04/2023
Date last updated
18/04/2023
Date data sharing statement initially provided
18/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intrauterine Instillation of Autologous Platelet Rich Plasma to promote the growth and regeneration of the endometrium for patients with recurrent implantation failure, poor endometrium within Assisted Reproductive Technology (ART) or Asherman's syndrome: Investigating the effect on successful pregnancy.
Scientific title
The use of Autologous Platelet Rich Plasma Intrauterine Instillation to treat recurrent implantation failure, poor endometrium within ART or Asherman’s syndrome.
Secondary ID [1] 309146 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Implantation Failure 329251 0
Asherman's Syndrome 329252 0
Thin Endometrium 329253 0
Condition category
Condition code
Reproductive Health and Childbirth 326206 326206 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autologous platelet-rich plasma (A-PRP) will be injected into the uterus of patients with recurrent implantation failure, thin endometrial lining or Asherman's Syndrome.

The PRP preparation kit is Alocuro PRO PRP 10mL device approved by the Therapeutics Goods Agency (TGA) listed on the Australian Register of Therapeutic Goods (ARTG) as a class II medical device, manufacturer - GoodmorningBio Co Ltd, Republic of Korea.
The kit contains:*Venepuncture equipment; Butterfly needle / White top syringe / Yellow top syringe x 2 (each containing 1mL of anti-coagulant). *PRP Preparation equipment; 10mL PRO PRP device (centrifuging tube) / S-Monovette-needle.

Trained phlebotomists will draw 10mLs of blood as per the manufacturer's instructions. A scientist trained in the preparation of A-PRP will prepare the blood sample as per the manufacturer's instructions, 10mLs of blood will harvest around 1mL of A-PRP. 5 minutes prior to the procedure, a scientist will "activate" the A-PRP with a single drop of blood from the white top syringe and then invert the tube multiple times. A FRANZCOG trained fertility clinician or nurse will inseminate the A-PRP into the uterus via an ET catheter.

For patients with a thin endometrium, the A-PRP instillation will occur 48 hours prior to trigger. For cases with recurrent implantation failure (RIF), instillation will occur 48 hours prior to Embryo Transfer (ET).

The intrauterine instillation (IUI) of A-PRP may be repeated on all subsequent IVF cycles, up to two times per cycle at the treating doctor's discretion. The blood collection and A-PRP preparation will take place in an RTAC / RTC / NATA accredited fertility clinic – Fertility North. The intrauterine instillation will take place in a treatment room at Fertility North (if performed under Local Anesthetic (LA)) or Joondalup Health Campus (JHC) hospital theatres (if performed under General Anesthetic (GA)).
Intervention code [1] 325642 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334148 0
Changes in endometrial thickness which will be determined via ultrasound imaging.
Timepoint [1] 334148 0
Endometrial thickness post intervention reviewed via follow up scan on the day of trigger.
Primary outcome [2] 334151 0
RIF treatment which will be analysed post pregnancy test via data-linkage to the patients medical records.
Timepoint [2] 334151 0
Confirmation of clinical pregnancy via ultrasound imaging 5 weeks post ovulation.
Primary outcome [3] 334257 0
Asherman's Syndrome treatment.
Timepoint [3] 334257 0
A successful ongoing pregnancy determined by blood tests and ultrasound imaging.
Secondary outcome [1] 419484 0
Rate of successful pregnancy determined by human chorionic gonadotropin (HCG) blood test.
Timepoint [1] 419484 0
Ongoing pregnancy data analysed in our patient database.

Eligibility
Key inclusion criteria
i. RIF
ii. Thin endometrium, (<7mm) on either an Invitro Fertilisation (IVF) cycle or Frozen Embryo Transfer (FET) cycle
iii. A history of a cancelled IVF or FET procedure due to thin endometrium
iv. Diagnosed with Asherman's syndrome
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Patients with an endometrium of >7mm and no RIF
ii. Patients with Premature Ovarian Failure (POF) due to a genetic condition e.g. Turners syndrome.
iii. Patients with Idiopathic thrombocytopenia (autoimmune platelet deficiency).
iv. Patients who are unable to undergo an IVF treatment cycle for any reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There is no expected sample size for the study, results and outcomes will be analysed on a yearly basis irrespective of the numbers of participants. An estimation of the number of participants within the first year is around 40, based on current patient numbers undergoing ovarian stimulation IVF cycles or frozen embryo transfer cycles at the clinic who have RIF, an endometrium of <7mm or diagnosed with Asherman's Syndrome.

Descriptive statistics such as number, frequencies, percentages, tables, graphs, means and standard deviations will be used for comparison. Inferential statistics will be obtained using paired t test pre and post intervention (p<0.05).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/07/2019
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
200
Accrual to date
129
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24279 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 39821 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 313347 0
Other
Name [1] 313347 0
Fertility North
Country [1] 313347 0
Australia
Primary sponsor type
Other
Name
Fertility North
Address
Fertility North
Suite 30, Level 2,
Joondalup Private Hospital,
60 Shenton Ave,
Joondalup
WA 6027
Country
Australia
Secondary sponsor category [1] 315095 0
None
Name [1] 315095 0
Address [1] 315095 0
Country [1] 315095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312569 0
Ramsay Health Care WA/SA Human Research Ethics Committee (RHC WA/SA HREC)
Ethics committee address [1] 312569 0
Research and Ethics Office
Joondalup Health Campus
PO BOX 242
Joondalup
WA 6919
Ethics committee country [1] 312569 0
Australia
Date submitted for ethics approval [1] 312569 0
17/04/2019
Approval date [1] 312569 0
02/07/2019
Ethics approval number [1] 312569 0

Summary
Brief summary
It is anticipated that intra-uterine instillation using autologous platelet-rich plasma (A-PRP) injected into the uterus will improve successful pregnancy outcomes in current IVF cycles and frozen embryo transfer cycles for women either with RIF, an endometrium of <7mm, or an Asherman's Syndrome diagnosis. In the non-randomised prospective trial, around 10mLs of your own blood (autologous) will be collected to produce around 1mL of A-PRP. The A-PRP will be injected into the uterus transvaginally via an embryo transfer catheter either 48 hours prior to trigger for thin endometrium cases or 48 hours prior to ET for RIF cases.
Trial website
Trial related presentations / publications
Public notes
Intra-uterine instillation of A-PRP is an extremely novel procedure and inclusion within the trial may not improve endometrial thickness, RIF or Asherman's syndrome and may not result in a pregnancy or live birth in current IVF or FET cycles.

Contacts
Principal investigator
Name 125126 0
Dr Vince Chapple
Address 125126 0
Fertility North,
Suite 30, Level 2,
Joondalup Private Hospital,
60 Shenton Ave,
Joondalup,
WA 6127
Country 125126 0
Australia
Phone 125126 0
+61 08 93011075
Fax 125126 0
Email 125126 0
vince.chapple@fertilitynorth.com.au
Contact person for public queries
Name 125127 0
Dr Yanhe Liu
Address 125127 0
Fertility North,
Suite 30, Level 2,
Joondalup Private Hospital,
60 Shenton Ave,
Joondalup,
WA 6127
Country 125127 0
Australia
Phone 125127 0
+61 08 93011075
Fax 125127 0
Email 125127 0
yanhe.liu@fertilitynorth.com.au
Contact person for scientific queries
Name 125128 0
Dr Yanhe Liu
Address 125128 0
Fertility North,
Suite 30, Level 2,
Joondalup Private Hospital,
60 Shenton Ave,
Joondalup,
WA 6127
Country 125128 0
Australia
Phone 125128 0
+61 08 93011075
Fax 125128 0
Email 125128 0
yanhe.liu@fertilitynorth.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Published results will be available to the general public. Raw data will be available on a case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by the Primary Sponsor / Principle Investigator - Dr Vince Chapple, via the Public / Scientific contact person Dr Yanhe Liu yanhe.liu@fertilitynorth.com.au


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.