RecruitingACTRN12623000390684

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.


Sponsor

Fertility North

Enrollment

200 participants

Start Date

Jul 10, 2019

Study Type

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

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

For couples struggling with infertility and undergoing IVF, one of the key challenges is building a thick, receptive uterine lining (endometrium) for the embryo to implant into. Some women have a persistently thin endometrium — below 7mm — or have had multiple failed embryo transfers (recurrent implantation failure), or have scarring inside the uterus from a condition called Asherman's syndrome. These situations significantly reduce the chance of a successful pregnancy. This study is testing whether injecting a small amount of platelet-rich plasma (PRP) — a concentration of growth factors made from the patient's own blood — directly into the uterus can help the endometrium grow thicker and more receptive. The PRP is prepared from about 10mL of blood, and injected into the uterus through a thin catheter 48 hours before the trigger injection or embryo transfer, depending on the type of cycle. You may be eligible if you are a woman between 18 and 45 years old undergoing IVF or frozen embryo transfer, and you have been diagnosed with recurrent implantation failure, a thin endometrium (under 7mm), or Asherman's syndrome. Women with normal endometrial thickness and no implantation failure would not be eligible.

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.

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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

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)

Joondalup Health Campus - Joondalup

WA, Australia

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ACTRN12623000390684


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