Platelet Rich Plasma for Insufficient Endometrium (PIER)

Reproductive Medicine Associates of New Jersey

Status: Enrolling

Conditions: Infertility of Uterine Origin

Treatments: Other: Normal saline Intrauterine infusion; Other: Platelet Rich Plasma Intrauterine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05538338

RMA-2022-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Intervention Group

Active Comparator group

Description:

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

Treatment:

Other: Platelet Rich Plasma Intrauterine infusion

Control Group

Placebo Comparator group

Description:

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

Treatment:

Other: Normal saline Intrauterine infusion