Platelet Rich Plasma for Insufficient Endometrium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Platelet Rich Plasma Intrauterine infusion, Normal saline Intrauterine infusion.
- Who it may be relevant to
- Registry conditions: Infertility of Uterine Origin. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial
Overview
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.
Interventions
- Other Platelet Rich Plasma Intrauterine infusion
an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants - Other Normal saline Intrauterine infusion
an intrauterine infusion of normal saline will be administered to this group of participants
Primary outcome measures
- Endometrial Thickness during frozen embryo transfer [Time frame: during the proliferative phase of the frozen embryo transfer cycle]
Secondary outcome measures (1)
- Sustained implantation rate [Time frame: approximately 9 weeks gestational age]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Reproductive Medicine Associates of New Jersey — Basking Ridge
Identifiers
NCT: NCT05538338 · RMA-2022-04