Platelet Rich Plasma Uterine Infusion

NCT06621342 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: STUDY00149149
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Endometriosis

Keywords

implantation failure; IVF; Embryo Transfer

Outcome Measures

Primary Outcomes (1)

• Determine the effect of autologous uterine PRP infusion on factors critical to the implantation process

  Compare differences of the levels TGF- b, IL-6 and LIF in endometrial secretions pre- and post-treatment.

  18 months

Secondary Outcomes (1)

• Determine the effect of autologous uterine PRP infusions on factors that are deleterious to embryo implantation

  18 months

Other Outcomes (1)

• Determine if autologous uterine PRP infusion influences implantation rates after frozen embryo transfer.

  18 months

Study Arms (2)

PRP Experimental

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

Biological: PRP Experimental

PRP Control

PLACEBO COMPARATOR

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

Biological: PRP Experimental

Interventions

PRP Experimental 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; PRP Experimental

Eligibility Criteria

• Age: 23 Years - 45 Years
• Gender Eligibility Details: Patients assigned female at birth, who are capable of becoming pregnant.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Eastern Virginia Medical School: collaborator

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Infertility; Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Courtney Marsh, MD, MPH

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 2\. It is not possible to blind clinical staff for the procedure. It is not necessary for the integrity of the study to blind participants as we are assessing their pregnancy outcomes. Regardless of which group they are assigned, participants will partake in routine prenatal care, as well as two additional study visits. They will know which group they have been assigned at the time of the procedure based on if they receive the treatment prior to implantation or not.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: October 1, 2024
• Study Start: February 16, 2023
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: October 1, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)