Clinical Trial: Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary:

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.


Sponsor: University of California, San Francisco

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

Endometrial thickness will be measured using transvaginal ultrasound per standard protocol


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: July 3, 2016
Date Started: November 2016
Date Completion: December 2017
Last Updated: November 18, 2016
Last Verified: November 2016