RecruitingNot ApplicableNCT05538338

Platelet Rich Plasma for Insufficient Endometrium

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


Sponsor

Reproductive Medicine Associates of New Jersey

Enrollment

62 participants

Start Date

Oct 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria2

  • 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 Criteria13

  • 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

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Interventions

OTHERPlatelet Rich Plasma Intrauterine infusion

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

OTHERNormal saline Intrauterine infusion

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


Locations(1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

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NCT05538338


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