Clinical trial NCT06621342: Platelet Rich Plasma Uterine Infusion
Official title: Evaluating Cytokine Concentrations in the Endometrium Before and After Autologous Platelet Rich Plasma Uterine Infusion Preceding Frozen Embryo Transfer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Infertility
Endometriosis
Keywords: implantation failure
IVF
Embryo Transfer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Eastern Virginia Medical School
First posted: 2024-10-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 patients will be enrolled in each of the control and test groups, using a confidence interval of 95% and a 5% margin of error Total participants expected = 80.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Platelet Rich Plasma (PRP), a rich source of important growth factors, has been shown to significantly affect the body's ability to heal and regenerate tissues. It is an affordable, accessible treatment with little risk of side effects that is being utilized in many areas of regenerative and cosmetic medicine. PRP is also relatively easy to prepare with supplies on hand in most IVF clinics. Specifically relating to reproductive function, PRP has been demonstrated to increase cellular proliferation and decrease fibrosis in damaged rat endometrium. It is hypothesized that infusing the uterus with Platelet Rich Plasma at measured intervals prior to embryo transfer will increase concentrations of implantation-promoting cytokines while reducing concentrations of inflammatory cytokines during the window of implantation.

Detailed description: 1. Platelet Rich Plasma (PRP), a rich source of important growth factors, has been shown to significantly affect the body's ability to heal and regenerate tissues.7 It is an affordable, accessible treatment with little risk of side effects that is being utilized in many areas of regenerative and cosmetic medicine. PRP is also relatively easy to prepare with supplies on hand in most IVF clinics. PRP has shown great promise in veterinary medicine to regenerate tissues and reduce endometrial inflammation.8 Specifically relating to reproductive function, PRP has been demonstrated to increase cellular proliferation and decrease fibrosis in damaged rat endometrium.6 Endometritis, which is characterized by an increase in inflammatory cells, erosion of the endometrial epithelial layer as well as endometrial edema has been a large cause of infertility in cattle and therefore revenue loss in the cattle industry. A recent study applying uterine infusion of PRP as the intervention demonstrated decreased markers for inflammation in cattle in vivo and as well as decreased inflammatory markers in in vitro cultured endometrial cells exposed to PRP.6 A similar in vitro study was conducted on horses; the authors noticed a decrease in clinical uterine infections in mares along with an increased embryo recovery rate.31 Chronic endometritis is hypothesized to be one of the potential factors involved in recurrent implantation failure in women.32 Using these previous studies in veterinary medicine as a model for potential benefit in human patients, it would be prudent to explore the mechanism of PRP action in humans. It is hypothesized that infusing the uterus with Platelet Rich Plasma at measured intervals prior to embryo transfer will increase concentrations of implantation-promoting cytokines while reducing concentrations of inflammatory cytokines during the window of implantation. TGF-b, IL-6 and LIF are known to be promoters of implantation, while TNF-a and IL-4 are pro-inflammatory factors and can inhibit implantation.

Eligibility criteria: Inclusion Criteria:

* Patient at REI clinic population
* Ages 23 to 45
* Undergo frozen embryo transfers with clinic standard medicated protocols
* Transferring one or two embryos on day 5 or 6 of development

Exclusion Criteria:

* BMI \>32
* Low level or high-level mosaic
* Aneuploid embryos only will be excluded
* Desiring day 3 or fresh embryo

Primary outcomes:
measure: Determine the effect of autologous uterine PRP infusion on factors critical to the implantation process
timeFrame: 18 months
Secondary outcomes:
measure: Determine the effect of autologous uterine PRP infusions on factors that are deleterious to embryo implantation
timeFrame: 18 months
Other outcomes:
measure: Determine if autologous uterine PRP infusion influences implantation rates after frozen embryo transfer.
timeFrame: 18 months
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Courtney Marsh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: