NCT05538338NARecruiting
Platelet Rich Plasma for Insufficient Endometrium
Reproductive Medicine Associates of New Jersey
Start Date
10/15/2022
Completion Date
12/1/2027
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.
Eligibility Criteria
Age Range: 18 years to 45 years
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
Interventions
OTHER
Platelet Rich Plasma Intrauterine infusion
OTHER
Normal saline Intrauterine infusion
Conditions
Infertility of Uterine Origin
Locations
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey 07920
United States