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

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ClinicalTrials.gov Identifier: NCT02825849
Recruitment Status : Unknown
Verified November 2016 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : November 22, 2016
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:

  • the chance of having embryo transfer,
  • implantation rate
  • clinical pregnancy rate

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

  • the rate of return/normalization of menses
  • the chance of spontaneous pregnancy
  • the chance of embryo transfer

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

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. 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

  2. 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

  3. 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



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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


Contacts
Contact: Lusine Aghajanova, MD, PhD 415-353-7475 lusine.aghajanova@ucsf.edu
Contact: Heather G. Huddleston, MD 415-353-7475

Locations
United States, California
University of California San Francisco - Center for Reproductive Health Recruiting
San Francisco, California, United States, 94158
Contact: Lusine Aghajanova, MD, PhD    415-353-7475    lusine.aghajanova@ucsf.edu   
Contact: Heather G. Huddleston, MD    415-353-7475      
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Heather G. Huddleston, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02825849     History of Changes
Other Study ID Numbers: 16-19764
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of California, San Francisco:
endometrium
thin uterine lining
uterine scarring

Additional relevant MeSH terms:
Infertility
Gynatresia
Genital Diseases, Male
Genital Diseases, Female