Platelet Rich Plasma for Insufficient Endometrium

Not Applicable

Recruiting

• Conditions: Infertility of Uterine Origin

• Registration Number: NCT05538338
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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.

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-13
• Study Start: 2022-10-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endometrial Thickness during frozen embryo transfer	during the proliferative phase of the frozen embryo transfer cycle	peak endometrial thickness prior to initiation of progesterone

Secondary Outcome Measures

Name	Time	Method
Sustained implantation rate	approximately 9 weeks gestational age	presence of fetal heart beat upon discharge from care

Trial Locations

Locations (1)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States