Platelet Rich Plasma for Insufficient Endometrium (PIER)

Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial

To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.

Study Overview

• Status: Recruiting
• Conditions: Infertility of Uterine Origin
• Intervention / Treatment: Other: Platelet Rich Plasma Intrauterine infusion; Other: Normal saline Intrauterine infusion

Detailed Description

Patients with a history of thin endometrium will be randomized to either an intrauterine infusion of PRP vs. a placebo infusion of normal saline. This is a double-blind, placebo controlled prospective RCT. Patients will then proceed with a frozen embryo transfer of a single euploid embryo per routine.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine V Whitehead, BSN, RN; Phone Number: 19736562841; Email: clinicalresearchteam@ivirma.com
• Study Contact Backup: Name: Caroline Zuckerman, BS; Phone Number: 19736562841; Email: clinicalresearchteam@ivirma.com

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Reproductive Medicine Associates of New Jersey
      • Contact: Caroline Zuckerman, BS; Phone Number: 19736562841; Email: clinicalresearchteam@ivirma.com
      • Contact: Christine V Whitehead, BSN, RN; Phone Number: 973-656-2841; Email: cwhitehead@ivirma.com
      • Principal Investigator: Jason Franasiak, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have previously undergone at least 2 unsuccessful frozen embryo transfer cycles, defined as failure to achieve a sustained clinical pregnancy (visualization of intrauterine gestational sac on ultrasound or a cancelled embryo transfer cycle due to inadequate endometrial thickness
• Patients with a diagnosis of thin endometrial lining (less than or equal to 6 mm maximum thickness) during prior unsuccessful or canceled embryo transfer cycles.

Exclusion Criteria:

• Fewer than 2 prior unsuccessful or canceled frozen embryo transfer cycles.
• Most recent unsuccessful embryo transfer prior to January 1, 2017.
• Mullerian anomalies, excluding arcuate uterus
• Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery
• Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
• Failure of patient to agree to enrollment in study with written consent.
• Concurrent pregnancy
• Anticoagulation use for which plasma infusion is contraindicated
• History of thrombosis
• Thrombophilia either inherited or acquired
• Concomitant use of adjunctive therapies for proliferation. These must be discontinued upon enrollment.
• Embryo planned to be used for transfer generated from surgically obtained sperm due to a diagnosis of non-obstructive azoospermia
• Recurrent/persistent endometrial fluid in prior cycles

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group	Other: Platelet Rich Plasma Intrauterine infusion; an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants
Placebo Comparator: Control Group; an intrauterine infusion of normal saline will be administered to this group	Other: Normal saline Intrauterine infusion; an intrauterine infusion of normal saline will be administered to this group of participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial Thickness during frozen embryo transfer	peak endometrial thickness prior to initiation of progesterone	during the proliferative phase of the frozen embryo transfer cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained implantation rate	presence of fetal heart beat upon discharge from care	approximately 9 weeks gestational age

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: RMA-2022-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No