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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02825849
Recruitment Status : Terminated (Low recruitment and competing studies have published.)
First Posted : July 7, 2016
Results First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Infertility Asherman's Syndrome Biological: Intrauterine infusion of platelet rich plasma Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
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
Official Title: Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study
Study Start Date : November 2016
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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 Name: 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



Primary Outcome Measures :
  1. Endometrial Thickness [ Time Frame: 3-30 days after treatment ]
    Endometrial thickness will be measured using transvaginal ultrasound per standard protocol


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825849


Locations
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United States, California
University of California San Francisco - Center for Reproductive Health
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Heather G. Huddleston, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Statistical Analysis Plan  [PDF] November 15, 2020
Study Protocol  [PDF] October 25, 2019
Informed Consent Form  [PDF] October 24, 2019

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02825849    
Other Study ID Numbers: 16-19764
First Posted: July 7, 2016    Key Record Dates
Results First Posted: February 9, 2021
Last Update Posted: February 9, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, San Francisco:
endometrium
thin uterine lining
uterine scarring
Additional relevant MeSH terms:
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Infertility
Gynatresia