None listed
Conditions
Brief summary
This study aims to determine whether infusing platelet-rich plasma (PRP) into the cavity of the womb can improve the chances of pregnancy for women who have experienced repeated unsuccessful in vitro fertilisation (IVF) attempts. PRP is derived from a small sample of the woman’s own blood and contains concentrated natural substances (growth factors) that promote healing and tissue regeneration. PRP has been successfully applied in other areas of medicine to support healing. This study will explore whether it can help prepare the uterus for a successful pregnancy. Participants will include women undergoing IVF who have experienced repeated unsuccessful implantation despite using high-quality embryos. They will be randomly assigned to one of two groups: one will receive PRP, and the other will have a similar procedure without PRP. For those in the PRP group, a small blood sample will be taken and processed to produce PRP, and the PRP will be gently infused into the uterus, two days before the embryo transfer. The study will span approximately five years to enable monitoring of pregnancy outcomes, including implantation, clinical pregnancy, miscarriage, and live birth rates. The research team is committed to ensuring participant safety, with all procedures performed by trained professionals. This study explores a potential new treatment option for women who have experienced repeated IVF failures.
Interventions
Platelet Rich Plasma (PRP) is an autologous blood product enriched with growth factors and cytokines. PRP is created from a small blood sample obtained from the participant and processed through centrifugation to separate and concentrate platelets. It is currently thought of as experimental but due to positive results in some studies it is used in clinical practice by some private clinicians at a cost to the patient in a variety of clinical scenarios including recurrent implantation failure, thin or scarred endometrium or injected into the ovary to help with response to hormonal stimulation in assisted reproductive technology. There is a long history of its use in other specialties for example musculoskeletal medicine and dermatology. PRP production involves no external devices or medications requiring regulatory approval. PRP can be created through the help of a commercially available kit. There is no evidence suggesting harm associated with PRP use. The treatment group will receive a single intrauterine infusion of PRP 2-3 days prior to embryo transfer. participants randomised to the intervention arm will undergo: • Blood collection of 8.5 mL, mixed with 1.5 mL of anticoagulant (acid citrate), 2–3 days prior to embryo transfer. • The sample is processed on-site using a two-step centrifugation protocol to isolate approximately 0.75 mL of PRP. Before administration, PRP is activated by mixing with 0.25 mL of non-coagulated whole blood. • A single intrauterine infusion of PRP will be performed using a soft embryo transfer catheter (e.g., GuardiaTM Access, Cook Medical), inserted through the cervix and up to the internal os. The PRP is infused gently into the endometrial cavity. • The procedure will be conducted by a fertility specialist or gynaecologist, in accordance with site-specific protocols. Participants in the placebo arm will undergo an identical procedure including blood draw and catheter insertion, but without PRP infusion. Adherence to the intervention protocol will be monitored through audit of clinic medical records, review of procedure documentation, and case report forms (CRFs). Each site will be required to document the completion of blood collection, PRP preparation, and the intrauterine infusion procedure, including timing relative to embryo transfer. Study-specific procedure logs and REDCap data entries will be used to confirm protocol compliance across both intervention and placebo arms.
Sponsors
Study design
Eligibility
Inclusion criteria
Women aged 20-42 years. Body Mass Index (BMI) less than 40 kg/m². Diagnosed with Recurrent Implantation Failure (RIF) based on an age-personalised cumulative clinical pregnancy rate calculation. For participants using donor gametes, the diagnosis of RIF will be based on the egg donor’s age to ensure consistency in embryo quality assessment. Embryos graded higher than 3BB, based on the Gardner and Schoolcraft morphology criteria, will be considered good quality for inclusion in the study. Participants undergoing PGT-A as part of their treatment. Participants undergoing a single blastocyst transfer (fresh or frozen) during an IVF cycle. Patients who have undergone an endometrial receptivity test in a previous cycle will not be excluded, provided they meet all other eligibility criteria. However, the timing of embryo transfer for this study will follow the standard protocol and will not be adjusted based on prior receptivity test results.
Exclusion criteria
Known chromosomal abnormalities in either the patient or partner, only in cases where embryos have not undergone PGT-A testing. Patients with chromosomal abnormalities may be included if they are transferring tested euploid embryos, as these abnormalities are unlikely to affect implantation outcomes in such cases. Structural uterine abnormalities. Haematological disorders. Autoimmune diseases. Untreated hydrosalpinx. Uncontrolled endocrinological disorders. Platelet count less than 150 x 10^9/L. Current use of anticoagulant medications or recent use of aspirin within 10 days, or non-steroidal anti-inflammatory drugs (NSAIDs) within 24 hours, prior to PRP collection. Patients with an endometrial thickness less than 7 mm on the day of transfer determination will not be included, as thin endometrium is associated with poor implantation outcomes. Endometrial thickness will be assessed by ultrasound, and patients with suboptimal thickness will be deferred until the endometrium measures at least 7 mm.