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.
The use of Autologous Platelet Rich Plasma Intrauterine Instillation to treat recurrent implantation failure, poor endometrium within ART or Asherman’s syndrome.
Fertility North
200 participants
Jul 10, 2019
Interventional
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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)).
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12623000390684