Platelet Rich Plasma Uterine Infusion

NCT ID: NCT06621342

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-16
• Study Completion Date: 2023-02-16

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.

Conditions

Infertility; Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

PRP Experimental

The treatment group will receive 1 ml of autologous PRP infused into the cervix via Rocket IUI catheter at 72+/- 5 hours and 48 +/- 5 hours prior to embryo transfer. Prior to the first PRP infusion, endometrial secretions will be aspirated as described in a previous study regarding endometrial secretions. An embryo transfer catheter will be introduced trans-cervically. A 2 mL syringe will be used to gradually add suction, aspirating secretions from the endometrium. The outer sheath of the embryo catheter will be positioned in the exterior, and the inner catheter retracted into the outer sheath, to avoid cervical fluid contamination in the collected endometrial secretions. Secretions will be deposited into screw top cryovials by snipping the end of the transfer catheter containing secretion off into the tube. These tubes will then be snap-frozen in liquid nitrogen. Process will be repeated prior to embryo transfer

Group Type: EXPERIMENTAL

PRP Experimental

Intervention Type: BIOLOGICAL

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.

PRP Control

Negative control patients will have endometrial secretions aspirated at identical intervals to the test group but will not receive PRP infusions.

Group Type: PLACEBO_COMPARATOR

PRP Experimental

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Virginia Medical School

OTHER

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Courtney Marsh, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

The University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00149149

Identifier Type: -

Identifier Source: org_study_id