Platelet Rich Plasma for Insufficient Endometrium

Study Overview
=================
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.

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

Conditions
-----------------
Infertility of Uterine Origin

Intervention / Treatment
-----------------
* Other: Platelet Rich Plasma Intrauterine infusion
* Other: Normal saline Intrauterine infusion


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group | Other: Platelet Rich Plasma Intrauterine infusion<br>* an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants<br>|
| Placebo Comparator: Control Group<br>an intrauterine infusion of normal saline will be administered to this group | Other: Normal saline Intrauterine infusion<br>* an intrauterine infusion of normal saline will be administered to this group of participants<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained implantation rate | presence of fetal heart beat upon discharge from care | approximately 9 weeks gestational age |