Platelet Rich Plasma for Insufficient Endometrium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infertility of Uterine Origin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention Group

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

Group Type ACTIVE_COMPARATOR

Platelet Rich Plasma Intrauterine infusion

Intervention Type OTHER

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

Control Group

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

Group Type PLACEBO_COMPARATOR

Normal saline Intrauterine infusion

Intervention Type OTHER

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

Interventions

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Platelet Rich Plasma Intrauterine infusion

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

Intervention Type OTHER

Normal saline Intrauterine infusion

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No