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NCT Number: NCT05538338

Platelet Rich Plasma for Insufficient Endometrium

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location status: Recruiting

Location contact

Caroline Zuckerman, BS

CONTACT

[email protected]

19736562841

Christine V Whitehead, BSN, RN

CONTACT

[email protected]

19736562841

Jason Franasiak, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet Rich Plasma Intrauterine infusion

Other

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

Normal saline Intrauterine infusion

Other

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

Primary outcomes

  1. Endometrial Thickness during frozen embryo transfer

    Time frame: during the proliferative phase of the frozen embryo transfer cycle

    peak endometrial thickness prior to initiation of progesterone

Secondary outcomes

  1. Sustained implantation rate

    Time frame: approximately 9 weeks gestational age

    presence of fetal heart beat upon discharge from care

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Zuckerman, BS

CONTACT

[email protected]

19736562841

Christine V Whitehead, BSN, RN

CONTACT

[email protected]

19736562841

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Official study title

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

Acronym: PIER

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 13, 2022
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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