Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair (PRP-E)

Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study

Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to standard therapies, present a significant clinical challenge. The aim of this trial is to assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial lining thickness in patients with thin lining or Asherman's Syndrome.

Study Overview

• Status: Terminated
• Conditions: Infertility; Asherman's Syndrome
• Intervention / Treatment: Biological: Intrauterine infusion of platelet rich plasma

Detailed Description

BACKGROUND:

There is a need for new and more effective therapies for patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly for patients resistant to standard therapies

HYPOTHESIS:

Platelet rich plasma stimulates cellular processes involved in endometrial regeneration relevant to management of a thin lining or intrauterine scarring.

PRIMARY AIMS:

- To measure the change in endometrial lining thickness

SECONDARY AIMS:

• To determine if fertility is improved in patients receiving platelet rich plasma (PRP):

  1. In patients with thin lining undergoing frozen embryo transfer (FET), to determine:

• clinical pregnancy rate

  2. In patients with Asherman's Syndrome, to determine:

• the chance of spontaneous pregnancy

Any adverse effects of study arm will be monitored and reported as appropriate.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California San Francisco - Center for Reproductive Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Persistent thin lining < 6mm on >1 cycle in previous IVF or FET cycle OR moderate-to-severe Asherman's syndrome

Exclusion Criteria:

• Age <18 years old or >43 years old,
• Pregnancy,
• Diagnosis of cancer,
• Hb <11 g/dL, platelets <150,000/mm3,
• Anticoagulation,
• NSAIDs in the 10 days before procedure
• Any significant comorbidity or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
• Incision in the uterus: myomectomy; cesarean section

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP intrauterine infusion; Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles	Biological: Intrauterine infusion of platelet rich plasma; Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP.; Other Names: PRP
No Intervention: Control group with standard treatment only; Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial Thickness	Endometrial thickness will be measured using transvaginal ultrasound per standard protocol	3-30 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Ultrasound Confirmed Clinical Pregnancies	Defined by ultrasound confirmed pregnancies per total participants in each arm	at least 7 weeks after treatment

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Heather G. Huddleston, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: July 3, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: endometrium; thin uterine lining; uterine scarring
• Additional Relevant MeSH Terms: Infertility; Gynatresia
• Other Study ID Numbers: 16-19764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No