Platelet Rich Plasma for Insufficient Endometrium

Infertility of Uterine Origin Clinical Trial

— PIER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538338
• Other study ID #: RMA-2022-04
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Reproductive Medicine Associates of New Jersey
• Contact: Christine V Whitehead, BSN, RN
• Phone: 19736562841
• Email: clinicalresearchteam[@]ivirma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility of Uterine Origin

Intervention

Other:
• Platelet Rich Plasma Intrauterine infusion
an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants
• Normal saline Intrauterine infusion
an intrauterine infusion of normal saline will be administered to this group of participants

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sustained implantation rate	presence of fetal heart beat upon discharge from care	approximately 9 weeks gestational age