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

• ClinicalTrials.gov Identifier: NCT02825849
• Recruitment Status: Terminated
• First Posted: July 7, 2016
• Results First Posted: February 9, 2021
• Last Update Posted: February 9, 2021
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: July 3, 2016
• First Posted Date: July 7, 2016
• Results First Submitted Date: December 2, 2020
• Results First Posted Date: February 9, 2021
• Last Update Posted Date: February 9, 2021
• Study Start Date: November 2016
• Actual Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 21, 2021)

Endometrial Thickness [ Time Frame: 3-30 days after treatment ]

Endometrial thickness will be measured using transvaginal ultrasound per standard protocol

Original Primary Outcome Measures (submitted: July 6, 2016)

Endometrial thickness [ Time Frame: 3-30 days after treatment ]

Endometrial thickness will be measured using transvaginal ultrasound per standard protocol

Current Secondary Outcome Measures (submitted: January 21, 2021)

Number of Participants With Ultrasound Confirmed Clinical Pregnancies [ Time Frame: at least 7 weeks after treatment ]

Defined by ultrasound confirmed pregnancies per total participants in each arm

Original Secondary Outcome Measures (submitted: July 6, 2016)

• Implantation rate (for patients with thin lining) [ Time Frame: approximately 7 weeks after treatment ]
  defined by number of gestational sacs seen on early pregnancy 6-week ultrasound divided by number of embryos transferred
• Clinical pregnancy rate (for patients with thin lining) [ Time Frame: approximately 7 weeks after treatment ]
  Defined by the number of fetal poles with heartbeat seen on 6-week ultrasound divided by the number of embryos transferred
• Return/normalization of menstrual flow (for patients with Asherman's Syndrome) [ Time Frame: 1-3 months after treatment ]
  Patients will be asked to record the menstrual flow diary (Menstrual Assessment Chart) before treatment and for 1-3 months after treatment

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair
• Official Title: Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study
• Brief Summary: 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.

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
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

During Study Period #1: Subjects were randomized to receive either PRP or standard care. A total of 13 subjects were randomized.

The study design was then altered to remove randomization (10/4/2018). All patients in Study Period #2 received PRP. An additional 14 subjects were enrolled in Study Period #2.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Infertility
• Asherman's Syndrome

Intervention

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 Name: PRP

Study Arms

• 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
  Intervention: Biological: Intrauterine infusion of platelet rich plasma
• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 21, 2021): 27
• Original Estimated Enrollment (submitted: July 6, 2016): 20
• Actual Study Completion Date: August 2019
• Actual Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 43 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02825849
• Other Study ID Numbers: 16-19764
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of California, San Francisco
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of California, San Francisco
• Verification Date: January 2021