None listed
Conditions
Brief summary
In Vitro Fertilisation (IVF) as a treatment for infertility, includes in part transferring an embryo (usually 5 days age) into the uterine cavity. Even with chromosomally normal embryos the resulting clinical pregnancy rate is 40-60%, indicating that approximately half of the embryos do not implant (implantation failure) The purpose of this study is to assess whether instilling 0.5-1.0 ml of autologous platelet rich plasma (PRP) into the uterine cavity 2-3 days prior to embryo transfer will lead to an improved clinical pregnancy rate. It is hypothesized that the PRP acts on the endometrium to improve receptivity for implantation.
Interventions
All participants will undergo a transabdominal ultrasound performed to measure endometrial thickness 2-3 days prior to the embryo transfer. This is a baseline measure for post-intervention assessment of changes in endometrial thickness. Participants randomized to Platelet rich plasma (PRP) infusion will undergo venepuncture 2-3 days prior to planned embryo transfer. The 10 ml whole blood sample taken will be prepared on site to yield autologous PRP. The sample will be centrifuged on a Scanfuge M
All participants will undergo a transabdominal ultrasound performed to measure endometrial thickness 2-3 days prior to the embryo transfer. This is a baseline measure for post-intervention assessment of changes in endometrial thickness. Participants randomized to Platelet rich plasma (PRP) infusion will undergo venepuncture 2-3 days prior to planned embryo transfer. The 10 ml whole blood sample taken will be prepared on site to yield autologous PRP. The sample will be centrifuged on a Scanfuge Maxi by Origio, first spin at 300g and second spin at 700g. An hour after the blood collection the participant will then have the PRP sample infused into the uterine cavity by a fertility specialist. This procedure will take approximately 10 minutes to complete and will be delivered only once, it will be assumed complete once the PRP injection is complete. There will not be a post procedure ultrasound. Administering the PRP solution: (1) The subject is placed in a lithotomy position (2) A speculum is inserted into the vagina and the cervix visualized (3) Any mucus or vaginal discharge is wiped from the cervix (4) A Cook catheter is gently inserted along the cervical canal and just beyond the internal os (5) A Cook catheter is then gently inserted into the uterine cavity and 0.5-1.0 mL of the PRP solution is slowly injected over about 15-30 seconds using minimal pressure. (6) The catheters and speculum are then removed.
Sponsors
Martin Healey
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. Women <40yo planned to undergo embryo transfer without pre-implantation genetic testing (PGT) who have had 1 or more consecutive previously failed embryo transfers (negative pregnancy test) ii. Women of any age planning to undergo embryo transfer with PGT performed who have had 1 or more consecutive previously failed embryo transfers (negative pregnancy test)
Exclusion criteria
i. Inability to provide informed consent ii. Use of donor oocyte, sperm or embryo iii. Congenital or acquired uterine malformation eg, Mullerian abnormality, Ashermann’s (this does not include subseptate or arcuate uterus) iv. Previously had embryo transfer as part of this study v. Multiple embryos transferred
Outcome results
None listed