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Platelet Rich Plasma for Insufficient Endometrium (PIER)

Primary Purpose

Infertility of Uterine Origin

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet Rich Plasma Intrauterine infusion
Normal saline Intrauterine infusion
Sponsored by
Reproductive Medicine Associates of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility of Uterine Origin

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Reproductive Medicine Associates of New JerseyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Group

Control Group

Arm Description

an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group

an intrauterine infusion of normal saline will be administered to this group

Outcomes

Primary Outcome Measures

Endometrial Thickness during frozen embryo transfer
peak endometrial thickness prior to initiation of progesterone

Secondary Outcome Measures

Sustained implantation rate
presence of fetal heart beat upon discharge from care

Full Information

First Posted
September 9, 2022
Last Updated
October 19, 2022
Sponsor
Reproductive Medicine Associates of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT05538338
Brief Title
Platelet Rich Plasma for Insufficient Endometrium
Acronym
PIER
Official Title
Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Medicine Associates of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility of Uterine Origin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
an intrauterine infusion of normal saline will be administered to this group
Intervention Type
Other
Intervention Name(s)
Platelet Rich Plasma Intrauterine infusion
Intervention Description
an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants
Intervention Type
Other
Intervention Name(s)
Normal saline Intrauterine infusion
Intervention Description
an intrauterine infusion of normal saline will be administered to this group of participants
Primary Outcome Measure Information:
Title
Endometrial Thickness during frozen embryo transfer
Description
peak endometrial thickness prior to initiation of progesterone
Time Frame
during the proliferative phase of the frozen embryo transfer cycle
Secondary Outcome Measure Information:
Title
Sustained implantation rate
Description
presence of fetal heart beat upon discharge from care
Time Frame
approximately 9 weeks gestational age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine V Whitehead, BSN, RN
Phone
19736562841
Email
clinicalresearchteam@ivirma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Zuckerman, BS
Phone
19736562841
Email
clinicalresearchteam@ivirma.com
Facility Information:
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine V Whitehead, BSN, RN
Phone
973-656-2841
Email
cwhitehead@ivirma.com
First Name & Middle Initial & Last Name & Degree
Caroline Zuckerman, BS
Phone
19736562841
Email
clinicalresearchteam@ivirma.com
First Name & Middle Initial & Last Name & Degree
Jason Franasiak, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Platelet Rich Plasma for Insufficient Endometrium

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