Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621342
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2023-01-24
Brief Title:
Platelet Rich Plasma Uterine Infusion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating Cytokine Concentrations in the Endometrium Before and After Autologous Platelet Rich Plasma Uterine Infusion Preceding Frozen Embryo Transfer
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study deferredstopped by initiator before any study recruitment was initiated
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Platelet Rich Plasma PRP a rich source of important growth factors has been shown to significantly affect the bodys 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 bodys ability to heal and regenerate tissues7 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 inflammation8 Specifically relating to reproductive function PRP has been demonstrated to increase cellular proliferation and decrease fibrosis in damaged rat endometrium6 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 PRP6 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 rate31 Chronic endometritis is hypothesized to be one of the potential factors involved in recurrent implantation failure in women32 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None