NCT06621342

Platelet Rich Plasma Uterine Infusion

Evaluating Cytokine Concentrations in the Endometrium Before and After Autologous Platelet Rich Plasma Uterine Infusion Preceding Frozen Embryo Transfer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Female
• Age: 23 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infertility
• Endometriosis

Interventions

Type	Name	Description
BIOLOGICAL	PRP Experimental	All participants will have 5 2ml tubes of blood collected at 72 +/- 5 hr prior to embryo transfer and again at 48 +/- 5 hour prior to embryo transfer. This blood will be processed to create PRP for the uterine infusion per protocol.

Timeline

• Start date: 2023-02-16
• Primary completion: 2023-02-16
• Completion: 2023-02-16
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study