None listed
Conditions
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.
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 syring
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)).
Sponsors
Fertility North
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
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.
Outcome results
None listed