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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

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Conditions

Infertility of Uterine Origin

Locations

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey 07920

United States